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Title: Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumors ≤15 mm (BR-003) | Condition: Malignant Neoplasm of Breast | Keywords: less than or equal to 15 mm | Summary: | Description: Subjects with biopsy-diagnosed malignant breast tumors less than or equal to 15 mm will be invited to participate. Subjects will receive a screening MRI and if eligible will then have laser ablation, followed by MRI and an excision at 4-6 weeks following the laser procedure. This study will be deemed successful if the lower limit of a 95% confidence interval for the proportion of patients who have complete tumor ablation with one Novilase laser ablation procedure at 4-6 weeks post-procedure is greater than the performance goal. Specifically, Novilase will have demonstrated success if the complete tumor ablation rate is greater than 87.85%. | ArmGroups: [{'label': 'Novilase Laser Ablation and excision', 'type': 'EXPERIMENTAL', 'description': 'Eligible subject will receive image-guided laser ablation of a targeted malignant breast tumor. At 4-6 weeks following the ablation, she will receive a MRI and excision. Pathology and MRI will determine rate of complete ablation. Subject is expected to proceed with radiation and/or adjuvant therapy per standard of care.', 'interventionNames': ['Device: Novilase Laser ablation']}] | Interventions:[{'type': 'DEVICE', 'name': 'Novilase Laser ablation', 'description': 'Image-guided, percutaneous laser ablation of breast tumors', 'armGroupLabels': ['Novilase Laser Ablation and excision']}] | PrimaryOutcomes: [{'measure': 'Percentage of target tumors completely ablated in one procedure', 'description': 'Efficacy: Rate of complete ablation by Novilase laser ablation', 'timeFrame': '4-6 weeks'}, {'measure': 'Frequency of adverse events (categorized using the NCI Common Terminology for Adverse Events (CTCAE) v4.0 guidelines) post-laser ablation and post-surgery', 'description': 'Safety: frequency of AEs', 'timeFrame': '4-6 weeks'}] | SecondaryOutcomes: [{'measure': 'Patient reported rate of return to activities of daily living post-laser ablation and post-surgery', 'description': 'Rate of recovery', 'timeFrame': '4-6 weeks'}, {'measure': 'Physician reported cosmetic satisfaction, utilizing the 4-point scoring system of breast cosmesis in protocol (e.g., excellent, good, fair, poor) post-laser ablation and post-surgery (4-6 weeks)', 'description': 'Post-procedure cosmetic satisfaction', 'timeFrame': '4-6 weeks'}, {'measure': 'Health related quality of life outcome measures at three timepoints via EORTC QLQ-C30 & QLQ-BR23 questionnaire (baseline and 4-6 weeks post-laser ablation and post-surgery)', 'description': 'Health-related quality of life outcome measures', 'timeFrame': '4-6 weeks'}]
Title: An Open-label Positron Emission Tomography Study to Investigate and Quantify Brain and Tumour Penetration of [11C]Lapatinib in Subjects With HER2-overexpressing Breast Cancer | Condition: Cancer | Keywords: Brain penetration, positron emission tomography, Lapatinib | Summary: | Description: Lapatinib is an anti-cancer drug taken by mouth which inhibits the HER2 protein, overexpressed in some breast tumours. It is not known whether lapatinib passes through the blood-brain barrier, and, therefore, whether it can target secondary tumours in the brain. This study will investigate whether lapatinib does indeed enter the brain. Subjects with HER2-overexpressing breast cancer, with and without brain metastases, will receive lapatinib tablets daily for 8 days. The subjects will also receive lapatinib with a small amount of radioactivity attached on the first and last days of dosing to investigate whether it is taken up by the brain, using positron emission tomography (PET) scans. | ArmGroups: [{'label': 'lapatinib', 'type': 'EXPERIMENTAL', 'description': 'unlabelled, administered orally', 'interventionNames': ['Drug: Lapatinib', 'Drug: [11C] lapatinib']}] | Interventions:[{'type': 'DRUG', 'name': 'Lapatinib', 'description': 'Unlabelled, administered orally', 'armGroupLabels': ['lapatinib'], 'otherNames': ['Tykerb', 'Tyverb']}, {'type': 'DRUG', 'name': '[11C] lapatinib', 'description': 'Radiolabelled, administered intravenously', 'armGroupLabels': ['lapatinib']}] | PrimaryOutcomes: [{'measure': 'Brain penetration of [11C]lapatinib', 'timeFrame': '8 days'}, {'measure': 'Brain tumour penetration of [11C]lapatinib', 'timeFrame': '8 days'}] | SecondaryOutcomes: [{'measure': 'Safety as assessed by number of subjects with adverse events', 'timeFrame': '16-19 days'}, {'measure': '[11C]lapatinib uptake in non-brain tumour sites', 'timeFrame': '8 days'}]
Title: Characterization of Peripheral Muscle Function in Patients With Non-small-cell Lung Cancer. | Condition: Non-Small-cell Lung Cancer | Keywords: Biopsy, Maximal incremental cardiopulmonary test, Muscle strength test, magnetic stimulation | Summary: | Description: N/A | ArmGroups: [{'label': 'Lung cancer patient with cachexia', 'description': 'Muscle lumbar area \\< 55cm2/m2 for men and \\< 39 cm2/m2 for women'}, {'label': 'Lung cancer patients without cachexia', 'description': 'Muscle lumbar area over 55cm2/m2 for men and 39 cm2/m2 for women'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Maximal quadriceps strength', 'timeFrame': '1 day (at the time of the diagnosis before any treatment)'}] | SecondaryOutcomes: [{'measure': 'Exercise capacity', 'timeFrame': '1 day (at the time of the diagnosis before any treatment)'}]
Title: A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy (Paclitaxel And Carboplatin) Vs. Chemotherapy Alone For The Treatment Of Advanced Stage Non-Small Cell Lung Cancer. | Condition: Lung Neoplasms | Keywords: | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'CP-547,632'}] | PrimaryOutcomes: [{'measure': 'Statistical estimates used on the Stage 1 data indicated low likely-hood of a positive outcome if the study continued to Stage 2. This provided the basis for discontinuation of the trial.'}] | SecondaryOutcomes: [{'measure': 'Given the outcome of the primary objective, analysis of secondary objectives were not formalized.'}]
Title: A Single Arm, Preoperative, Pilot Study to Evaluate the Safety and Biological Effects of Orally Administered Reparixin in Early Breast Cancer Patients Who Are Candidates for Surgery | Condition: Breast Cancer | Keywords: Cancer Stem Cells, Novel targeted therapy, CXCR1/2 Inhibitors | Summary: | Description: According to the cancer stem cell (CSC) model, tumors are organized in a cellular hierarchy maintained by a subpopulation of cells displaying stem cell properties. These properties include self-renewal (which drives tumorigenesis) and differentiation (which generates the tumor bulk and contributes to cellular heterogeneity). CSCs were first observed in hematological malignancies but have also been identified in solid tumors of breast, prostate, brain, colon and pancreas. CSCs are thought to be resistant to conventional chemotherapies and this may be why relapse occurs in many patients and this might explain the failure to develop therapies that are consistently able to eradicate solid tumors. Although currently available drugs can shrink metastatic tumors, these effects are usually transient and often do not appreciably extend the life of patients. One reason for the failure of these treatments is the acquisition of drug resistance by the cancer cells as they evolve; another possibility is that existing therapies fail to kill CSCs effectively. Existing therapies have been developed largely against the bulk population of tumor cells because they are often identified by their ability to shrink tumors. Because most cancer cells have limited proliferative potential, an ability to shrink a tumor mainly reflects an ability to kill these cells. It seems that normal stem cells from various tissues tend to be more resistant to chemotherapeutics than mature cell types from the same tissues. The reasons for this are not clear, but may relate to high levels of expression of anti-apoptotic proteins or adenosine triphosphate-binding cassette transporters such as the multidrug resistance gene. If the same were true of CSCs, then one would predict that these cells would be more resistant to chemotherapeutics than tumor cells with limited proliferative potential. Even therapies that cause complete regression of tumors might spare enough CSCs to allow re-growth of the tumors. Therapies that are more specifically directed against CSCs might result in much more durable responses and even cures of metastatic tumors. There are limited data on the impact of treatment tailoring based on CSC detection. Gene profiling of CSCs could lead to identification of therapeutic targets on CSCs (e.g. hormone receptors (HR), human epidermal growth factor receptor-2 \[HER-2\] expression, epidermal growth factor receptor \[EGFR\] expression), and could represent tumor biopsy in "real time". Several groups showed frequent discordance of HER-2 status between primary tumor and CSCs, and case reports showed clinical utility for the use of trastuzumab-based therapy based on HER-2 CSCs status. Similarly, the hormonal status of CSCs could be different from that of the primary tumor, which could lead to increase the number of patients suitable for endocrine therapy, but also could explain why endocrine therapy fails in a subset of HR positive (HR+) patients. More specifically, a recent observation from Ginestier et al. demonstrated that over expression of chemokine receptor 1 (CXCR-1) is associated with the aldehyde dehydrogenase positive (ALDH+) cells. In breast carcinomas, the ALDEFLUOR+ phenotype shows partial overlap with the CD44+CD24-Lin-CSC phenotype. Cellular hierarchies have been identified in a series of molecularly characterized breast cancer cell lines and it has been demonstrated that these lines contained ALDEFLUOR+ components that were both tumorigenic and metastatic in NOD/SCID mice. Furthermore, previous observations demonstrated that the addition of recombinant interleukin-8 (IL-8) increased the CSC population as well as increasing its propensity for invasion. Moreover, tissue damage induced by chemotherapeutic agents may induce IL-8 as part of the injury response. This suggests that strategies aimed at interfering with the IL 8/CXCR-1 axis may be able to target CSCs, increasing the efficacy of current therapies. This experimental data provides another therapeutic target in breast cancer. Reparixin seems to be a good candidate for use in breast cancer patients because of its very acceptable toxicity profile shown in the Phase I and II clinical trials conducted so far, along with its observed activity in vitro against breast cancer cell lines and in vivo in tumor xenografts in mice. A phase 1 study is currently underway to study the effects of reparixin in combination with paclitaxel in metastatic breast cancer. This small pilot study aims at exploring the effects on breast CSC markers as well as the safety and PK profile of orally administered single agent reparixin in HER-2 negative (HER-2-) early breast cancer patients in the 3 weeks prior to surgery. The study will be performed in the interval between disease diagnosis and planned surgery and may lead to a minimal delay in surgery. This is balanced by the potential benefits of the study by evaluating CSCs and their prognostic importance as well as obtaining information about the impact of reparixin therapy. | ArmGroups: [{'label': 'Treated patients - Total', 'type': 'EXPERIMENTAL', 'description': 'Patients eligible will be treated with Reparixin as add-in monotherapy', 'interventionNames': ['Drug: Reparixin']}] | Interventions:[{'type': 'DRUG', 'name': 'Reparixin', 'description': '1000 mg Oral Reparixin t.i.d. for 21 consecutive days prior to surgery', 'armGroupLabels': ['Treated patients - Total'], 'otherNames': ['REP']}] | PrimaryOutcomes: [{'measure': 'Change From Baseline to Day 21 in Markers of Cancer Stem Cells (CSCs) in the Primary Tumor and the Tumoral Microenvironment (ALDH1,CD44/CD24)', 'description': 'CSCs were measured in tissue samples by the following techniques: ALDH-1 by ALDEFLUOR and by immunohistochemistry (IHC); CD44/CD24 by flow cytometry or examination of RNA transcripts by RT-PCR and by immunohistochemistry (IHC); epithelial mesenchymal markers (Snail, Twist, Notch) by immunohistochemistry (IHC).', 'timeFrame': 'At day 21'}, {'measure': 'Change From Baseline-1 to Day 21-1 in Pathway Markers by IHC', 'description': 'Pathway markers (AKT, FAK, PTEN and CXCR1) were measured in tissue samples at the pre-study (Day -14 to 0) and Day 21 (or within 24 hours of last dose). For the evaluation of the stain extent, the following semi-quantitative score method (0 to 4) was used: 0, no positive cells; 1, 1-25%; 2, 26-50%; 3, 51-75%; and 4, 76-100%. Hence for this scale, the higher the values, the worse is the outcome. For the evaluation of the stain intensity, the following score method (0 to 3) was used: 0, negative; 1, weak; 2, moderate, 3; strong. Also for this scale, the higher the score, the worse the outcome.\n\nSerine-threonine protein kinase (AKT, also known as protein kinase B, PKB) Focal adhesion kinase (FAK) Chemokine receptor-1 (CXCR1)', 'timeFrame': 'Day 21 (or last day of treatment)'}, {'measure': 'Change From Baseline to Day 21 in Markers of Inflammation', 'description': 'Markers of inflammation (IL-1β, IL-6, IL-8, TNF-α, GM-CSF, VEGF, and b-FGF) were measured in plasma from peripheral blood.\n\nIL = interleukins TNF-α = tumor necrosis factor-alpha GM-CSF = macrophage colony stimulating factor VEGF = vascular endothelial growth factor b-FGF = basic fibroblast growth factor', 'timeFrame': 'At Day 21'}, {'measure': 'Change From Baseline-1 to Day 21-1 in Markers of Angiogenesis (CD31 Staining)', 'description': 'CD31 staining by IHC. For the evaluation of the stain extent, the following semi-quantitative score method (0 to 4) was used: 0, no positive cells; 1, 1-25%; 2, 26-50%; 3, 51-75%; and 4, 76-100%. Hence for this scale, the higher the values, the worse is the outcome. For the evaluation of the stain intensity, the following score method (0 to 3) was used: 0, negative; 1, weak; 2, moderate, 3; strong. Also for this scale, the higher the score, the worse the outcome.\n\nCD31 is a transmembrane glycoprotein, 130-140 kDa, also know as platelet-endothelium cell adhesion molecule (PECAM-1). CD31 is ligand for CD38 and plays a role in thrombosis and angiogenesis. CD31 is strongly expressed in endothelial cells and weakly expressed in megakaryocytes, platelets, occasional plasma cells, lymphocytes (espc. marginal zone B-cells, peripheral T-cells) and neutrophils.', 'timeFrame': 'At day 21'}, {'measure': 'Change From Baseline-1 to Day 21-1 in Markers of Autophagy (P62 and LC3B by IHC)', 'description': 'Autophagy is a lysosomal degradation and recycling process implicated in cancer progression and therapy resistance. Labeling of p62 serves as a useful marker for the induction of autophagy, clearance of protein aggregates, and the inhibition of autophagy. Labeling of LC3B serves to track the binding of p62 and subsequent recruitment of autophagosomes.\n\nFor the evaluation of the extent, the following semi-quantitative score method (0 to 4) was used: 0, no positive cells; 1, 1-25%; 2, 26-50%; 3, 51-75%; and 4, 76-100%. Hence for this scale, the higher the values, the worse is the outcome. For the evaluation of the intensity, the following score method (0 to 3) was used: 0, negative; 1, weak; 2, moderate, 3; strong. Also for this scale, the higher the score, the worse the outcome.', 'timeFrame': 'At day 21'}] | SecondaryOutcomes: [{'measure': 'Pharmacokinetics of Reparixin (DF1681Y, DF1681Y Unbound, DF2243Y, DF2188Y) - Cmax', 'description': 'Once absorbed, reparixin is highly protein bound. By comparing Cmax and AUC for unbound drug to that for total drug, only \\< 0.1% to 0.2% of reparixin is available as unbound (free) drug. The intent of the PK outcomes was not to compare the results between the two cohorts; for this reason results for the PK outcomes are reported for the whole group of the treated patients.\n\nCmax = Maximum plasma concentration obtained directly from the data without interpolation, expressed in concentration units', 'timeFrame': 'At Days 1 (pre-first dose and 0.25, 0.5, 1, 2, 4, 6, 8h post dose) and 21(pre-first dose and 0.25, 0.5, 1, 2, 4, 6, 8h post dose)'}, {'measure': 'Pharmacokinetics of Reparixin (DF1681Y, DF1681Y Unbound, DF2243Y, DF2188Y) - Tmax and T1/2', 'description': 'Once absorbed, reparixin is highly protein-bound. By comparing Cmax and AUC for unbound drug to that for total drug, only \\< 0.1% to 0.2% of reparixin is available as unbound (free) drug. The intent of the PK outcomes was not to compare the results between the two cohorts; for this reason results for the PK outcomes are reported for the whole group of the treated patients.\n\ntmax = Time to reach the maximum plasma concentration obtained directly from the data without interpolation t1/2 = Terminal elimination half-life calculated as ln(2)/ lambda z; calculated only if the coefficient of determination R2 in lambda z estimation is at least 0.8.', 'timeFrame': 'At Days 1 (pre-first dose and 0.25, 0.5, 1, 2, 4, 6, 8h post dose) and 21(pre-first dose and 0.25, 0.5, 1, 2, 4, 6, 8h post dose)'}, {'measure': 'Pharmacokinetics of Reparixin (DF1681Y, DF1681Y Unbound, DF2243Y, DF2188Y) - AUC0-8, AUCinf, AUClast, AUCtau at Day 21,', 'description': 'The intent of the PK outcomes was not to compare the results between the two cohorts; for this reason results for the PK outcomes are reported for the whole group of the treated patients.\n\nAUC0-8 = The area under the plasma concentration-time curve from time 0 to 8 hours post-dose; AUClast = The area under the concentration-time curve from time 0 to last quantifiable concentration AUCtau = The area under the plasma concentration-time curve for dosing interval (dosing interval \\[tau\\] = 8 hours); AUCinf = The total area under the plasma concentration-time curve from time zero to time infinity; AUC0-inf = AUClast + Clast/lambda zeta, where Clast is the last observed concentration ≥ lower limit of quantitation at time tlast.\n\nAll these parameters were calculated by the linear trapezoidal rule.', 'timeFrame': 'At Days 1 (pre-first dose and 0.25, 0.5, 1, 2, 4, 6, 8h post dose) and 21(pre-first dose and 0.25, 0.5, 1, 2, 4, 6, 8h post dose)'}, {'measure': 'Pharmacokinetics of Reparixin (DF1681Y, DF1681Y Unbound, DF2243Y, DF2188Y) - CL/F (L/h) at Day 1, CLSS/F (L/h) Day 21)', 'description': 'The intent of the PK outcomes was not to compare the results between the two cohorts; for this reason results for the PK outcomes are reported for the whole group of the treated patients.\n\nCL/F = Apparent oral clearance - for DF1681Y only, calculated as dose/AUCinf.; calculated only when the coefficient of determination R2 in lambda zeta estimation is at least 0.8 and percent AUC extrapolation is less than or equal to 20%.\n\nCLss/F = Steady state apparent oral clearance - for DF1681Y only calculated as dose/AUCtau.', 'timeFrame': 'At Days 1 (pre-first dose and 0.25, 0.5, 1, 2, 4, 6, 8h post dose) and 21(pre-first dose and 0.25, 0.5, 1, 2, 4, 6, 8h post dose)'}, {'measure': 'Change From Baseline to Day 21 in Leukocytes Subsets', 'description': 'The Leukocytes subsets analyzed are the following: Lymphocyte in WBC, Total T cell in lymphocytes, B cells in lymphocytes, T-helper cell in lymphocytes, CTL in lymphocytes, NKT cell in lymphocytes, ADCC NK subsets in lymphocytes, Regulatory NK subsets in lymphocytes, Exhausted NK subsets in lymphocytes, CD56-CD16+ NK subsets in lymphocytes, CD11b in PMNs - IL-8, CD18 in PMNs - IL-8, MFI of CD11b - IL-8, MFI of CD66b - IL-8, MFI of CD18 - IL-8, CD11b in PMNs - US, CD18 in PMNs - US, MFI of CD11b - US, MFI of CD66b - US, MFI of CD18 - US, Percent Monocytes expressing IL6 - IL-8,Percent Monocytes expressing IL1b - IL-8, Percent Monocytes expressing IL8 - IL-8, Percent Monocytes expressing TNFa - IL-8, Percent Neutrophils expressing IL6 - IL-8, Percent Neutrophils expressing IL1b - IL-8, Percent Neutrophils expressing IL8 - IL-8, Percent Neutrophils expressing TNFa - IL-8,Percent Monocytes expressing IL6 - US,Percent Monocytes expressing IL1b - US, etc.', 'timeFrame': 'At Day 21'}]
Title: A Multi-indication, Single-treatment Arm, Open-label Phase 2 Study of Regorafenib and Nivolumab in Combination in Patients With Recurrent or Metastatic Solid Tumors | Condition: Solid Tumors | Keywords: Pancreatic Ductal Adenocarcinoma (PDAC), Head and Neck Squamous Cell Carcinoma (HNSCC), Esophageal Squamous Cell Carcinoma (ESCC), Glioblastoma Multiforme (GBM), Anaplastic Astrocytoma (AA), Biliary Tract Carcinoma (BTC), PD-1 inhibitor, nivolumab, regorafenib, multi-kinase inhibitor | Summary: | Description: N/A | ArmGroups: [{'label': 'Regorafenib+Nivolumab', 'type': 'EXPERIMENTAL', 'description': 'Parallel-cohort in adult participants with selected recurrent or metastatic tumors (HNSCC, ESCC, PDAC, BTC, and GBM/AA) who have been previously treated with one or more systemic therapy for the selected tumor indication.', 'interventionNames': ['Drug: Regorafenib, (Stivarga, BAY73-4506)', 'Drug: Nivolumab (Opdivo)']}] | Interventions:[{'type': 'DRUG', 'name': 'Regorafenib, (Stivarga, BAY73-4506)', 'description': 'Intake orally, starting with 3x 30 mg tablets every day (once daily.) for 21 days of every 28-day cycle (21 days on, 7 days off).\n\nIf the starting dose is well tolerated dose can be escalated to 120 mg (4x30 mg tablets).', 'armGroupLabels': ['Regorafenib+Nivolumab']}, {'type': 'DRUG', 'name': 'Nivolumab (Opdivo)', 'description': '480 mg administered on Day 1 of each treatment cycle.', 'armGroupLabels': ['Regorafenib+Nivolumab']}] | PrimaryOutcomes: [{'measure': 'Overall Response Rate (ORR)', 'description': 'Tumor response was evaluated as ORR per RECIST 1.1 by local assessments for all tumor types, except for GBM/AA, where ORR per RANO by local assessment was used. ORR was defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR). Participants for whom best overall tumor response was not CR or PR, as well as participants without any post-baseline tumor assessment were considered non-responders. Descriptive statistics were done, no inferential statistical analyses were performed.', 'timeFrame': 'From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 months'}] | SecondaryOutcomes: [{'measure': 'Duration of Response (DOR)', 'description': 'Defined as the time (in days) from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. participants with a CR or PR.', 'timeFrame': 'From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 months'}, {'measure': 'Disease Control Rate (DCR)', 'description': 'CR = Complete response; PR = Partial response; SD = Stable disease', 'timeFrame': 'From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 months'}, {'measure': 'Progression Free Survival (PFS)', 'description': 'PFS was defined as the time (in days) from the start of study intervention to the date of first objectively documented progressive disease (PD) or death from any cause (if no progression was documented).', 'timeFrame': 'From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 months'}, {'measure': '6 Months PFS', 'description': '6 Months PFS rate', 'timeFrame': 'Up to last participant follow 6 months (approximately 22 months)'}, {'measure': 'Overall Survival (OS)', 'description': 'OS was defined as the time (in days) from the start of study intervention to the date of death due to any cause.', 'timeFrame': 'From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 months'}, {'measure': '1 Year OS', 'timeFrame': 'From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 month]'}, {'measure': 'Number of Participants With Adverse Events', 'description': 'AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.', 'timeFrame': 'Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months'}]
Title: An Exploratory Clinical Study of Statins for Improving Chemotherapy and Maintenance in Patients With Ovarian Cancer: a Prospective, Multicenter Clinical Study | Condition: Ovarian Cancer | Keywords: Statins | Summary: | Description: N/A | ArmGroups: [{'label': 'Statin Group', 'type': 'EXPERIMENTAL', 'description': 'Statins, 40 mg daily for 1 year or with dosage adjusted based on patient tolerance', 'interventionNames': ['Drug: Statin']}, {'label': 'Control Group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Sugar pill daily for 1 year', 'interventionNames': ['Drug: Sugar pill']}] | Interventions:[{'type': 'DRUG', 'name': 'Statin', 'description': 'Statin Group: Conventional chemotherapy and maintenance therapy combined with statins.', 'armGroupLabels': ['Statin Group']}, {'type': 'DRUG', 'name': 'Sugar pill', 'description': 'Control Group: Conventional chemotherapy and maintenance therapy alone.', 'armGroupLabels': ['Control Group']}] | PrimaryOutcomes: [{'measure': 'Progression free survival', 'description': 'The time between the start of the trial and tumor progression (in any way) or death (from any cause)', 'timeFrame': '12-month'}, {'measure': 'Disease free survival', 'description': 'Time from surgical resection to local recurrence', 'timeFrame': '12-month'}] | SecondaryOutcomes: [{'measure': 'Changes of tumor marker CA125', 'description': 'Changes in Serum CA125 from Enrollment to End of Trial', 'timeFrame': '12-month'}, {'measure': 'Changes of tumor marker HE4', 'description': 'Changes in Serum HE4 from Enrollment to End of Trial', 'timeFrame': '12-month'}, {'measure': 'Lipid change', 'description': 'Changes in Serum Lipid from Enrollment to End of Trial', 'timeFrame': '12-month'}]
Title: Pharmacokinetic and Pharmacodynamic Studies of Liothyronine. A Study on the Metabolic Effects of Thyroid Hormone | Condition: Malignant Struma Ovarii, Papillary Thyroid Cancer, Hurthle Cell Thyroid Cancer, Follicular Thyroid Cancer, Tall Cell Variant Thyroid Cancer | Keywords: Hypothyroidism, Thyroid Cancer, Triiodothyronine (T3), Energy Expenditure, Thyroid Hormone | Summary: | Description: In human adults thyroid hormone action plays a critical role in the modulation of metabolism and the function of virtually all organ/systems. The specificity of the hormonal action is ultimately the result of the interaction of the active hormone, triiodothyronine (T3), with the receptors isoforms and the co-activators and co-repressors specific for the various cells target of the hormonal action. Circulating and tissue levels of T3 are the result of the secretion of T3 and its precursor, thyroxine (T4), from the thyroid gland, the peripheral conversion of T4 into T3, and the degradation of these hormones. This complex system has only been partially studied in humans and very little is known regarding the kinetics of T3, and in particular on the correlation between circulating levels of T3 and end-organ target tissue thyroid hormone action. The aim of this protocol is to characterize the pharmacokinetics of T3 and its biological effects at various concentrations in a cohort of thyroidectomized patients undergoing thyroid hormone replacement therapy withdrawal for the management of thyroid cancer. Sixteen patients with a clinical indication for thyroid hormone withdrawal in preparation for 131I therapy or 123I diagnostic scan for follow-up and management of differentiated thyroid cancer will be recruited for this study. After enrollment in the study, the patients baseline characteristics will be determined during an outpatient visit while receiving levothyroxine (L-T4) therapy. The L-T4 therapy then will be suspended and substituted with an equivalent thrice daily liothyronine (L-T3) therapy for one month. Patients will be admitted to the NIH Clinical Center on the day prior to withdrawal of the T3 therapy until the diagnostic scan or the administration of radioactive iodine. During the hospitalization for this research protocol, which is expected to last eleven days, the following studies will be performed: serial blood sampling for circulating thyroid hormones to obtain pharmacokinetic parameters of L-T3, lipids, glucose and insulin, resting energy expenditure, echocardiogram, skeletal muscle strength measurement, cardiac, hepatic and skeletal muscles MRI, and quality of life and well-being questionnaires. The pharmacokinetic parameters of L-T3 will also be assessed with the first dose after the diagnostic scan or the administration of radioactive iodine. The results obtained from this study will help in understanding the effects of thyroid hormone on metabolism, and may lead to important information on how to optimize the duration of the thyroid hormone therapy withdrawal for the treatment of thyroid cancer. | ArmGroups: [{'label': 'Group 1', 'description': 'Adults with clinical indication for withdrawal from thyroid hormone replacement therapy in preparation for nuclear medicine imaging or therapeutic procedures with radioactive iodine'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': '1. To assess the pharmacokinetics of T3 in patients devoid of endogenous or exogenous T4 during acute L-T3 withdrawal at steady- state and after the first L-T3 dose administration', 'description': 'to study T3 kinetics in thyroidectomized patients treated with liothyronine (L- T3) replacement therapy in preparation for diagnostic or therapeutic nuclear medicine procedures for the follow-up and management of differentiated thyroid cancer', 'timeFrame': '4 weeks after stopping L-T4 thyroid hormone replacement therapy and starting L-T3 treatment'}, {'measure': '2. To estimate the minimal duration of L-T3 therapy withdrawal required to achieve a serum TSH level, equal or greater than 30 uIU/mL, to assure effective 131I therapy for treatment of differentiated thyroid cancer', 'description': 'to study T3 kinetics in thyroidectomized patients treated with liothyronine (L- T3) replacement therapy in preparation for diagnostic or therapeutic nuclear medicine procedures for the follow-up and management of differentiated thyroid cancer', 'timeFrame': '4 weeks after stopping L-T4 thyroid hormone replacement therapy and starting L-T3 treatment'}, {'measure': '3. To correlate clinical and biochemical parameters of thyroid hormone action, with circulating levels of T3 during L-T3 therapy withdrawal', 'description': 'to study T3 kinetics in thyroidectomized patients treated with liothyronine (L- T3) replacement therapy in preparation for diagnostic or therapeutic nuclear medicine procedures for the follow-up and management of differentiated thyroid cancer', 'timeFrame': '4 weeks after stopping L-T4 thyroid hormone replacement therapy and starting L-T3 treatment'}] | SecondaryOutcomes: N/A
Title: Mechanisms Explaining Psychological Distress In CErvical Cancer Patients and Partners (DICE): a Population-based Prospective Study | Condition: Cervical Cancer, Psychologic Stress, Psychological Distress, Survivorship, Quality of Life | Keywords: | Summary: | Description: Study design: Prospective population-based study in which cervical cancer patients and their partners are included shortly after diagnosis and followed until 10 years after diagnosis. Patients from treatment centres in the Netherlands and their partners will be asked to complete questionnaires after diagnosis, after 6 months, and after 1, 2, 5 and 10 year. Clinical data like disease stage, initial treatment and mortality will be extracted from the Netherlands Cancer Registry. In a subsample of patients, additionally objective lifestyle (actigraph, biosensor) and biological (blood, hair) measures are assessed at diagnosis and after 6, 12 and 24 months. . Study population: Newly diagnosed stage 1-3 cervical cancer patients (N=520) and their partners (N=312, expected) from any treatment centre in the Netherlands will be asked to fill out questionnaires. In a subsample of patients (N=116) additionally lifestyle and biological measures are assessed at all time-points. Main study parameters/endpoints: psychological distress (anxiety, depression, perceived stress, cancer worry) Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients and partners are asked to complete a questionnaire at 6 points in time: after diagnosis, after 6 months, and after 1, 2, 5 and 10 year. Patients will additionally be asked to complete an online food diary for 3 days. A subsample of patients will be asked to donate blood samples (2X10 ml, 10 minutes) to assess inflammation markers and telomere length, to donate a scalp hair sample (10 mg) to assess hormone production after diagnosis and after 6, 12 and 24 months, and to wear an Actigraph activity tracker to assess physical activity and sleep and a Philips Biosensor to assess heart rate variability as a marker of vagal nerve function at 6, 12 and 24 months. | ArmGroups: [{'label': 'Cervical cancer patients and their partners', 'description': '520 cervical cancer patients will complete questionnaires, online food diary and wear a fitbit after diagnosis, after 6 months, and after 1, 2, 5 and 10 years. In addition, a subsample (n=116) will donate blood samples and a scalp hair sample after diagnosis and 6, 12 and 24 months. We expect 312 partners of cervical cancer patients to included in the study and complete questionnaires after diagnosis, after 6 months, and after 1, 2, 5 and 10 years'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Anxiety/ depression', 'description': 'Hospital Anxiety and Depression Scale (1-21, higher scores indicate more anxiety or depression)', 'timeFrame': '24 months'}] | SecondaryOutcomes: [{'measure': 'Cancer worry', 'description': 'Impact of Cancer version 2 (Worry Scale) (0-5, higher scores indicate more worry)', 'timeFrame': '24 months'}, {'measure': 'Perceived stress', 'description': 'Perceived Stress Scale (0-40, higher scores indicate more perceived stress)', 'timeFrame': '24 months'}, {'measure': 'Health-related quality of life', 'description': 'EORTC Quality of Life Questionnaire (QLQC30) (0-100, higher scores indicate better quality of life or more symptoms)', 'timeFrame': '24 months'}, {'measure': 'Cervical cancer health-related quality of life', 'description': 'EORTC Cervical Cancer Module (CX24) (0-100, higher scores indicate better quality of life or more symptoms)', 'timeFrame': '24 months'}, {'measure': 'Sexual Health', 'description': 'EORTC Sexual Health Questionnaire (SHQ22) (0-100, higher scores indicate better quality of life or more symptoms)', 'timeFrame': '24 months'}]
Title: A Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Previously Treated With Anti-PD-1 or Anti-PD-L1 Antibodies (KEYNOTE-A04) | Condition: Solid Tumor, Adult | Keywords: | Summary: | Description: This is a Phase 1/2a, multicenter, dose-finding, consecutive-cohort, open-label trial of BI-1206 in combination with pembrolizumab in subjects with advanced solid tumors who have previously received treatment with a PD-1/PD-L1 immune checkpoint inhibitor. The trial will consist of 2 main parts: Phase 1 with 2 different sets of cohorts assessing IV or SC dosing, with dose escalation of BI-1206 and selection of the RP2D of IV dosing (ivRP2D) and the RP2D of SC dosing (scRP2D). Phase 2a with 3 expansion cohorts at the scRP2D for all subjects treated with pembrolizumab and BI-1206. Each of the 3 expansion cohorts will comprise a specific subset of subjects with advanced solid tumors (e.g., non-small-cell lung cancer, metastatic melanoma, and other tumor types known to be responsive to PD-1/PD-L1 immune checkpoint inhibition). Subjects will initially receive 3 cycles of therapy with pembrolizumab in combination with BI-1206, either IV or SC. Subjects who show clinical benefit (CR, PR, or SD) at the Week 9 Visit may continue on combination therapy (pembrolizumab/BI-1206). Starting at Week 10, these subjects will receive additional cycles of pembrolizumab and BI-1206 every 3 weeks for up to 32 additional cycles or up to 2 years from their first dose of BI-1206 therapy or until progression. | ArmGroups: [{'label': 'BI-1206 + Pembrolizumab 25mg/mL (MK-3475)', 'type': 'EXPERIMENTAL', 'description': 'BI-1206 administrated either IV or SC + Pembrolizumab 200mg administered IV every third week as a fixed dose will be used.', 'interventionNames': ['Drug: BI1206']}] | Interventions:[{'type': 'DRUG', 'name': 'BI1206', 'description': 'BI-1206 administrated either IV or SC every third week. Pembrolizumab 200mg administered IV every third week as a fixed dose will be used in Phase 1 and IIa.\n\nThe mTPI2 Design will be used for both the IV and SC cohorts. ivRP2D and scRP2D to be used in Phase', 'armGroupLabels': ['BI-1206 + Pembrolizumab 25mg/mL (MK-3475)'], 'otherNames': ['Pembrolizumab 25mg/mL (MK-3475)']}] | PrimaryOutcomes: [{'measure': 'Documenting AEs and SAEs and determining causality in relation to BI-1206 IV or SC and/or pembrolizumab', 'description': 'Assess the safety and tolerability profile of increasing doses of BI-1206 in combination with pembrolizumab, graded according to National Cancer Institute \\[NCI\\]-CTCAE version 4.0', 'timeFrame': 'Up to 2 year'}, {'measure': 'Determining the MTD of BI-1206 at the same dose level experiencing a BI-1206 or pembrolizumab-related or possibly related dose-limiting toxicity (DLT)', 'description': 'Select the RP2D dose for BI-1206 IV and SC using mTPI-2 design.', 'timeFrame': 'During the 42-day treatment period on induction therapy'}] | SecondaryOutcomes: [{'measure': 'Evaluation of PK parameters for BI-1206 IV and SC.', 'description': 'Determine the PK parameter s of BI-1206 ((i.e., AUC, Cmax, Tmax, and half-life \\[t½\\])', 'timeFrame': 'Up to 2 year'}, {'measure': 'Evaluation of ADA response to BI-1206 IV or SC', 'description': 'Assess the immunogenicity of BI-1206.', 'timeFrame': 'Up to 2 year'}, {'measure': 'Measurement of CD32b receptor occupancy on B cells.', 'description': 'Evaluate the effect of BI-1206 IV or SC when administered in combination with pembrolizumab on CD32b receptor occupancy on B cells in subjects with advanced solid tumors.', 'timeFrame': 'Up to 2 year'}]
Title: Young Adult Survivors United Cancer Research Registry | Condition: Cancer, Leukemia, Sarcoma, Germ Cell Cancer, Lymphoma, Colorectal Cancer, Melanoma, Breast Cancer | Keywords: young adult cancer | Summary: | Description: N/A | ArmGroups: N/A | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Anxiety', 'description': 'General Anxiety Disorder-7 (GAD-7). Scores range from 0-21 with higher scores indicating higher levels of anxiety.', 'timeFrame': 'enrollment in registry, 6 months later, yearly until death'}, {'measure': 'Depressive symptoms', 'description': 'Patient Health Questionnaire- 9 (PHQ-9) Scores range from 0-27, with higher scores indicating more depressive symptoms.', 'timeFrame': 'enrollment in registry, 6 months later, yearly until death'}, {'measure': 'Social Support', 'description': 'MOS Social Support Survey Instrument The survey consists of four separate social support subscales and an overall functional social support index. A higher score for an individual scale or for the overall support index indicates more support.\n\nMOS Social Support Survey Instrument\n\nMeasure of Social Support Survey Instrument', 'timeFrame': 'enrollment in registry, 6 months later, yearly until death'}, {'measure': 'Financial Toxicity', 'description': 'COST: A FACIT Measure of Financial Toxicity (COST - FACIT (Ver 2)) Scores range from 0-44. The higher the score, the better the Financial Well-Being', 'timeFrame': 'enrollment in registry, 6 months later, yearly until death'}, {'measure': 'Needs Assessment', 'description': 'AYA Psycho-Oncology Screening Tool (AYA-POST) There is no scoring required for this tool.', 'timeFrame': 'enrollment in registry'}] | SecondaryOutcomes: [{'measure': 'Name, address, email, phone number', 'description': 'Contact information if willing to be alerted about future research', 'timeFrame': 'enrollment in registry'}]
Title: Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue During Hematopoetic Stem Cell Transplantation for Multiple Myeloma | Condition: Cancer-related Problem/Condition, Depression, Circadian Rhythm Disorders | Keywords: Autologous Stem Cell Transplant, Multiple Myeloma, oncology, circadian rhythms, light therapy, Hematopoietic stem cell transplantation | Summary: | Description: N/A | ArmGroups: [{'label': 'PEI Experimental Light', 'type': 'EXPERIMENTAL', 'description': "Ambient light fixture installed in the patient's hospital room", 'interventionNames': ['Device: PEI Experimental Light']}, {'label': 'Comparison Light', 'type': 'ACTIVE_COMPARATOR', 'description': "Ambient light fixture installed in the patient's hospital room", 'interventionNames': ['Device: Comparison Light']}] | Interventions:[{'type': 'DEVICE', 'name': 'PEI Experimental Light', 'description': 'Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.', 'armGroupLabels': ['PEI Experimental Light']}, {'type': 'DEVICE', 'name': 'Comparison Light', 'description': 'Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.', 'armGroupLabels': ['Comparison Light']}] | PrimaryOutcomes: [{'measure': 'FACIT-Fatigue Scale', 'description': 'The FACIT-Fatigue scale is a13 item scale, full scale 0-52, with higher score indicating better functioning or less fatigue.', 'timeFrame': 'Baseline, Day 2, 7, 14, 28 and 90'}] | SecondaryOutcomes: [{'measure': 'Multidimensional Fatigue', 'description': "The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Tested for its psychometric properties in cancer patients receiving radiotherapy, patients with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians, it was found to have good Test-retest Reliability (r=0.80) and great Internal Consistency (Cronbach's alpha = 0.92).", 'timeFrame': 'up to 3 months'}, {'measure': 'The Pittsburgh Sleep Quality Index', 'description': 'The Pittsburgh Sleep Quality Index consists of 19 self-rated instrument full scale from 0-21, with higher score indicating poorer sleep quality.', 'timeFrame': 'Baseline, Day 30 and Day 90'}, {'measure': 'SF-36 Scale', 'description': 'Quality of life assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability', 'timeFrame': 'Baseline and 30 days post hospital discharge'}, {'measure': 'Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale)', 'description': 'Number of participants with score 16 or greater on CES-D, 20 item questionnaire that reflects major dimensions of depression: depressed mood; feelings of guilt and worthlessness; feelings of helplessness and hopelessness; psychomotor retardation; loss of appetite; and sleep disturbance. Full score from 0- 20, with higher score indicating more symptomology.', 'timeFrame': 'Baseline, Day 2, Day 7, and Day 14 post transplant'}, {'measure': 'CES-D (Center for Epidemiologic Studies Depression Scale)', 'description': 'CES-D, 20 item questionnaire that reflects major dimensions of depression: depressed mood; feelings of guilt and worthlessness; feelings of helplessness and hopelessness; psychomotor retardation; loss of appetite; and sleep disturbance. Full score from 0- 20, with higher score indicating more symptomology.', 'timeFrame': 'Baseline, Day 2, 7, 14, 28, and 90'}, {'measure': 'The Positive and Negative Affect Schedule (PANAS)', 'description': 'PANAS is a 20-item self-report measure of positive and negative affect. Each item rated on a 5-point scale of 1 (not at all) to 5 (extremely), each subscale from 1-5, full score from 1-5, with higher score indicating more symptoms. Change in PANAS at Day 30 and Day 90 as compared to baseline.', 'timeFrame': 'Baseline, Day 30, Day 90'}, {'measure': 'Change in Brief Symptoms Inventory-18 (BSI-18)', 'description': 'Brief Symptom Inventory-18 (BSI-18) - self-report 18-item instrument. Raw scores on the BSI-18 are converted to t-scores based on gender-specific normative data from non-patient community dwelling U.S. adults. A T-score = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating more symptom.', 'timeFrame': 'Baseline and Day 90'}, {'measure': 'Fatigue Line Scale', 'description': 'Simple numeric graphic rating scale, marked on a line numbering 0-100, with higher score indicating more fatigue. Replaces the FACIT fatigue scale for daily fatigue assessment during inpatient procedures.', 'timeFrame': 'baseline, day 2, 7, and 14'}, {'measure': 'Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)', 'description': 'Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) is a 30-item short form of the MFSI that measures five dimensions: general, physical, emotional, mental fatigue, and vigor. Each item is rated on a five-point Likert scale from 0 (not at all) to 4 (extremely). The total MFSI-SF score ranges from 0-4, with a higher score indicating a higher fatigue level.', 'timeFrame': 'Baseline, Day 30 after Discharge, Day 90 after Discharge'}, {'measure': 'Sleep Latency', 'description': 'Sleep latency measured by actigraph - Sleep latency is the average period of time between bed time and sleep start time', 'timeFrame': 'Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge'}, {'measure': 'Sleep Efficiency', 'description': 'Sleep efficiency measured by actigraph - Sleep efficiency is defined as the average percentage of time in bed actually spent sleeping', 'timeFrame': 'Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge'}, {'measure': 'Wake Time', 'description': 'Wake time measured by actigraph. Wake time is the average number of minutes the participant spent awake each night during the 5 day period. Baseline assessments were taken before transplant and day 2 is two days after transplant which is at least one week after the baseline.', 'timeFrame': 'Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge'}, {'measure': 'Wake Percent', 'description': 'Wake percent measured by actigraph - Wake percent is the average percent of each night spent awake', 'timeFrame': 'Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge'}, {'measure': 'Sleep Time', 'description': 'Sleep time measured by actigraph. Sleep time - average number of minutes the participant was asleep each night during the 5 day period. Baseline assessments were taken before transplant and day 2 is two days after transplant which is at least one week after the baseline.', 'timeFrame': 'Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge'}, {'measure': 'Sleep Percent', 'description': 'Sleep percent measured by actigraph. Sleep percent is the percent of time spent in bed that the participant is asleep.', 'timeFrame': 'Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge'}, {'measure': 'Melatonin', 'description': 'Melatonin level', 'timeFrame': 'Baseline and Discharge'}]
Title: A Phase 1b Multi-cohort Study of the Combination of Pembrolizumab (MK-3475) Plus Binimetinib Alone or the Combination of Pembrolizumab Plus Chemotherapy With or Without Binimetinib in Participants With Metastatic Colorectal Cancer (KEYNOTE-651) | Condition: Metastatic Colorectal Cancer | Keywords: CRC, MSS, non-MSI-H, PD-1, anti-PD-1, anti PD-1, MEK, MEK inhibitor | Summary: | Description: N/A | ArmGroups: [{'label': 'Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg', 'type': 'EXPERIMENTAL', 'description': 'Participants in Cohort A will receive pembrolizumab (200 mg) intravenous (IV) every 3 weeks (Q3W) plus binimetinib orally at of 30 mg twice a day (BID) until disease progression or discontinuation.', 'interventionNames': ['Biological: Pembrolizumab', 'Drug: Binimetinib']}, {'label': 'Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg', 'type': 'EXPERIMENTAL', 'description': 'Participants in Cohort A will receive pembrolizumab (200 mg) IV Q3W plus binimetinib orally at 45 mg BID (Dose Level 2 \\[DL2\\]) until disease progression or discontinuation.', 'interventionNames': ['Biological: Pembrolizumab', 'Drug: Binimetinib']}, {'label': 'Cohort B Part 1: Pembrolizumab + mFOLFOX7', 'type': 'EXPERIMENTAL', 'description': 'Participants in Cohort B will receive pembrolizumab (200 mg) IV Q3W plus mFOLFOX7 (oxaliplatin 85 mg/m\\^2; leucovorin \\[calcium folinate\\] 400 mg/m\\^2; fluorouracil \\[5-FU\\] 2400 mg/m\\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.', 'interventionNames': ['Biological: Pembrolizumab', 'Drug: Oxaliplatin', 'Drug: Leucovorin', 'Drug: 5-Fluorouracil [5-FU]']}, {'label': 'Cohort B Part 2: Pembrolizumab + mFOLFOX', 'type': 'EXPERIMENTAL', 'description': 'During Part 2, participants in Cohort B will receive pembrolizumab (200 mg) IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\\^2; leucovorin \\[calcium folinate\\] 400 mg/m\\^2; fluorouracil \\[5-FU\\] 2400 mg/m\\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.', 'interventionNames': ['Biological: Pembrolizumab', 'Drug: Oxaliplatin', 'Drug: Leucovorin', 'Drug: 5-Fluorouracil [5-FU]']}, {'label': 'Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg', 'type': 'EXPERIMENTAL', 'description': 'Participants in Cohort C will receive pembrolizumab 200 mg IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\\^2; leucovorin \\[calcium folinate\\] 400 mg/m\\^2; fluorouracil \\[5-FU\\] 2400 mg/m\\^2 over 46-48 hours) IV Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.', 'interventionNames': ['Biological: Pembrolizumab', 'Drug: Binimetinib', 'Drug: Oxaliplatin', 'Drug: Leucovorin', 'Drug: 5-Fluorouracil [5-FU]']}, {'label': 'Cohort D Part 1: Pembrolizumab + FOLFIRI', 'type': 'EXPERIMENTAL', 'description': 'Participants in Cohort D will receive a standard dose (DL1) of pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\\^2; leucovorin \\[calcium folinate\\] 400 mg/m\\^2; 5-FU 2400 mg/m\\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.', 'interventionNames': ['Biological: Pembrolizumab', 'Drug: Leucovorin', 'Drug: 5-Fluorouracil [5-FU]', 'Drug: Irinotecan']}, {'label': 'Cohort D Part 2: Pembrolizumab + FOLFIRI', 'type': 'EXPERIMENTAL', 'description': 'During Part 2, participants in Cohort D will receive pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\\^2; leucovorin \\[calcium folinate\\] 400 mg/m\\^2; 5-FU 2400 mg/m\\^2 over 46-48 hours) until disease progression or discontinuation.', 'interventionNames': ['Biological: Pembrolizumab', 'Drug: Leucovorin', 'Drug: 5-Fluorouracil [5-FU]', 'Drug: Irinotecan']}, {'label': 'Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg', 'type': 'EXPERIMENTAL', 'description': 'Participants in Cohort E will receive pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\\^2; leucovorin \\[calcium folinate\\] 400 mg/m\\^2; 5-FU 2400 mg/m\\^2 over 46-48 hours) Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.', 'interventionNames': ['Biological: Pembrolizumab', 'Drug: Binimetinib', 'Drug: Leucovorin', 'Drug: 5-Fluorouracil [5-FU]', 'Drug: Irinotecan']}, {'label': 'Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 45 mg', 'type': 'EXPERIMENTAL', 'description': 'During Part 2, participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\\^2; leucovorin \\[calcium folinate\\] 400 mg/m\\^2; 5-FU 2400 mg/m\\^2 over 46-48 hours) Q2W plus binimetinib orally at the starting dose of 45 mg BID until disease progression or discontinuation. Cohort A During Part 2, participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\\^2; leucovorin \\[calcium folinate\\] 400 mg/m\\^2; 5-FU 2400 mg/m\\^2 over 46-48 hours) Q2W plus binimetinib orally at the starting dose of 45 mg BID until disease progression or discontinuation.', 'interventionNames': ['Biological: Pembrolizumab', 'Drug: Binimetinib', 'Drug: Leucovorin', 'Drug: 5-Fluorouracil [5-FU]', 'Drug: Irinotecan']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'Pembrolizumab', 'description': '200 mg Pembrolizumab solution for IV infusion Q3W', 'armGroupLabels': ['Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg', 'Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg', 'Cohort B Part 1: Pembrolizumab + mFOLFOX7', 'Cohort B Part 2: Pembrolizumab + mFOLFOX', 'Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg', 'Cohort D Part 1: Pembrolizumab + FOLFIRI', 'Cohort D Part 2: Pembrolizumab + FOLFIRI', 'Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg', 'Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 45 mg'], 'otherNames': ['MK-3475']}, {'type': 'DRUG', 'name': 'Binimetinib', 'description': 'tablet orally BID at 30 or 45 mg depending upon DLT profile', 'armGroupLabels': ['Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg', 'Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg', 'Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg', 'Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg', 'Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 45 mg'], 'otherNames': ['MEK162, ARRY-162, ARRY-438162']}, {'type': 'DRUG', 'name': 'Oxaliplatin', 'description': '85 mg/m\\^2 as IV infusion. Administered Q2W as part of mFOLFOX7 cocktail. Dose may be de-escalated to 70 mg/m\\^2 if the standard dose of mFOLFOX7 is deemed too toxic per mTPI, based upon occurrence of DLTs.', 'armGroupLabels': ['Cohort B Part 1: Pembrolizumab + mFOLFOX7', 'Cohort B Part 2: Pembrolizumab + mFOLFOX', 'Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg']}, {'type': 'DRUG', 'name': 'Leucovorin', 'description': '400 mg/m\\^2 as IV infusion. Administered Q2W as part of mFOLFOX7 or FOLFIRI cocktail, depending upon allocation.', 'armGroupLabels': ['Cohort B Part 1: Pembrolizumab + mFOLFOX7', 'Cohort B Part 2: Pembrolizumab + mFOLFOX', 'Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg', 'Cohort D Part 1: Pembrolizumab + FOLFIRI', 'Cohort D Part 2: Pembrolizumab + FOLFIRI', 'Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg', 'Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 45 mg'], 'otherNames': ['calcium folinate']}, {'type': 'DRUG', 'name': '5-Fluorouracil [5-FU]', 'description': '2400 mg/m\\^2 over 46-48 hours as IV infusion. Administered Q2W as part of mFOLFOX7 or FOLFIRI cocktail, depending upon allocation. Dose may be de-escalated to 2000 mg/m\\^2 if the standard dose of mFOLFOX7 or FOLFIRI is deemed too toxic per mTPI, based upon occurrence of DLTs.', 'armGroupLabels': ['Cohort B Part 1: Pembrolizumab + mFOLFOX7', 'Cohort B Part 2: Pembrolizumab + mFOLFOX', 'Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg', 'Cohort D Part 1: Pembrolizumab + FOLFIRI', 'Cohort D Part 2: Pembrolizumab + FOLFIRI', 'Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg', 'Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 45 mg']}, {'type': 'DRUG', 'name': 'Irinotecan', 'description': '180 mg/m\\^2 as IV infusion. Administered Q2W as part of FOLFIRI cocktail. Dose may be de-escalated to 150 mg/m\\^2 if the standard dose of FOLFIRI is deemed too toxic per mTPI, based upon occurrence of DLTs.', 'armGroupLabels': ['Cohort D Part 1: Pembrolizumab + FOLFIRI', 'Cohort D Part 2: Pembrolizumab + FOLFIRI', 'Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg', 'Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 45 mg']}] | PrimaryOutcomes: [{'measure': 'Percentage of Participants Who Experienced Dose-Limiting Toxicity (DLT)', 'description': 'The occurrence of any of the following toxicities during Part 1 of the study (the first 21 days for Cohort A, first 28 days for Cohorts B,C, D, \\& E), if possibly, probably or definitely related to study treatment, was considered a DLT:\n\nGrade (Gr) 4 non hematologic toxicity, Gr 4 hematologic toxicity lasting \\>7 days, Gr 3 thrombocytopenia, Any non-hematologic AE ≥Gr 3 in severity, Any Gr 3 or Gr 4 non-hematologic laboratory value, Febrile neutropenia Gr 3 or Gr 4, Any prolonged delay in initiating study therapy due to a treatment-related AE that started during the DLT period, Any treatment-related toxicity that causes the participant to discontinue treatment during the DLT period, Missing \\>25% of binimetinib doses as a result of drug-related AE(s), Gr 5 toxicity, Cardiac disorders and vascular disorders, Eye disorders (Retinopathy or retinal detachment Gr ≥ 3).', 'timeFrame': 'Up to approximately first 28 days of treatment'}] | SecondaryOutcomes: [{'measure': 'Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)', 'description': 'ORR was determined in all participants and was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). The percentage of participants who experienced CR or PR is presented. Per Protocol, analysis was per cohort.', 'timeFrame': 'Up to Approximately 64 months'}]
Title: A Phase 1, Multi-center, Open-label, Single-arm, Dose-escalation, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of FN-1501 Monotherapy in Patients With Advanced Solid Tumors or Relapsed/Refractory Acute Myeloid Leukemia (AML) | Condition: Advanced Cancer, Solid Tumors, Acute Myeloid Leukemia Refractory, Acute Myeloid Leukemia, in Relapse | Keywords: | Summary: | Description: This is a phase 1, first-in-human, open-label, multicenter, dose escalation study. Dose escalation will follow the traditional 3+3 design. Patients will be screened for eligibility for up to 28 days prior to entry into the study. The starting dose will be 2.5 mg/day (once daily). The period for DLT assessment is 21 days from the first dose of FN-1501. Evaluation of a cohort of at least three (3) patients completing DLT assessment at any given dose level is required prior to determining the next dose level and dose regimen for the subsequent cohort. After the first patient in the cohort receives the Cycle 1, Day 1 dose, subsequent patients in that cohort will not be dosed until the first patient has been evaluated for at least 48 hours to exclude unexpected acute toxicity. The continuous safety evaluation will be performed by investigators, the medical monitor, and the sponsor. A Safety Monitoring Committee (SMC) will determine dose levels to be administered and dose regimen during dose escalation based on the data available from the previous dose levels. If an MTD is not identified due to paucity of DLTs, the RP2D will be determined based on pharmacokinetics, safety, tolerability, and preliminary efficacy. If a patient wishes to continuously receive study treatment on completion of Cycle 1, the patient can continue study treatment in 21-day Cycle 2 and subsequent cycles (same as Cycle 2, all of 21 days' duration), defined as administration of 3 times per week for 2 weeks followed by one week off, at the discretion of the investigator. The primary endpoint of this study is to determine the recommended phase 2 dose (RP2D) of FN-1501 based on pharmacokinetics, safety and tolerability, as well as preliminary efficacy. | ArmGroups: [{'label': 'FN-1501', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: FN-1501']}] | Interventions:[{'type': 'DRUG', 'name': 'FN-1501', 'description': "Eligible patients will receive a single intravenous infusion of study drug on Days 1, 3, 5, 8, 10, and 12 of a 21-day cycle. Dosing will begin at 2.5 mg once per day on the assigned days. Dose escalation will use the traditional 3+3 design and follow a modified Fibonacci sequence until MTD is reached. Increments of 33% in the dose of FN-1501 will be undertaken after reaching 30 mg/day. At least 3 patients will be enrolled in each cohort. Administration of FN-1501 will be continued until disease progression, intolerable toxicity, withdrawal of consent, or termination according to the Principal Investigator's judgment or at the sponsor's request.", 'armGroupLabels': ['FN-1501']}] | PrimaryOutcomes: [{'measure': 'Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03', 'timeFrame': 'From first dose until 30 days after the last dose.'}, {'measure': 'To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)', 'description': 'The recommended phase 2 dose (RP2D) of FN-1501 will be determined based on pharmacokinetics, safety and tolerability, as well as preliminary efficacy.', 'timeFrame': 'During the first year.'}] | SecondaryOutcomes: [{'measure': 'Area under the plasma concentration-time curve from zero to the last measurable concentration (AUC0-last)', 'timeFrame': 'During the first year.'}, {'measure': 'Area under concentration-time curve from 0 to 24 hours (AUC(0-24))', 'timeFrame': 'During the first year.'}, {'measure': 'Area under the plasma concentration time curve from zero to infinity (AUC0-∞)', 'timeFrame': 'During the first year.'}, {'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'During the first year.'}, {'measure': 'Time to maximum observed plasma concentration (tmax)', 'timeFrame': 'During the first year.'}, {'measure': 'Terminal half-life (t1/2)', 'timeFrame': 'During the first year.'}, {'measure': 'Clearance (CL)', 'timeFrame': 'During the first year.'}, {'measure': 'Apparent volume of distribution (Vd)', 'timeFrame': 'During the first year.'}, {'measure': 'Measurement of anti-tumor activity of FN-1501 according to RECIST version 1.1 (solid tumor)', 'timeFrame': 'During the first year.'}, {'measure': 'Measurement of anti-tumor activity of FN-1501 including but not limited to CT/MRI images', 'timeFrame': 'During the first year.'}]
Title: Observational Study With Metronomic Oral Vinorelbine in Elderly Patients With Locally Advanced / Metastatic Non-small-cell Lung Cancer (NSCLC) | Condition: Locally Advanced/ Metastatic NSCLC | Keywords: | Summary: | Description: Vinorelbine is the first line reference drug in the elderly patient with locally advanced / metastatic non-small-cell lung cancer (NSCLC). The introduction of the oral formulation of vinorelbine has determined a further impulse to its use in 1st line and above all to its use as "metronomic" therapy. Metronomic chemotherapy offers the advantage of increasing the overall dosage of the drug administered, but reducing the side effects or making them more easily manageable; it is practically a question of administering fractionated doses of the drug continuously for long periods (generally up to the progression of unacceptable disease or toxicity). This study collects data on the efficacy and tolerability of oral metronomic vinorelbine in elderly patients with NSCLC, performed as per normal clinical practice. | ArmGroups: [{'label': 'VINORELBINA', 'description': "Vinorelbine 40 mg (2 cps of 20 mg) three times a week (Monday. Wednesday, Friday), for the first 2 weeks.\n\nStarting from the third week, in the absence of any severe toxicity (≥ 3) and in the opinion of the clinician, the dosage can be increased to 50 mg (1 cps from 30 + 1 cps from 20 mg), three times a week ( Monday, Wednesday, Friday) continuously.\n\nThe dosage of 40 or 50 mg is continued until progression, patient refusal or unacceptable toxicity (in the clinician's opinion).", 'interventionNames': ['Drug: Vinorelbine']}] | Interventions:[{'type': 'DRUG', 'name': 'Vinorelbine', 'description': "Vinorelbine 40 mg (2 cps of 20 mg) three times a week (Monday. Wednesday, Friday), for the first 2 weeks.\n\nStarting from the third week, in the absence of any severe toxicity (≥ 3) and in the opinion of the clinician, the dosage can be increased to 50 mg (1 cps from 30 + 1 cps from 20 mg), three times a week ( Monday, Wednesday, Friday) continuously.\n\nThe dosage of 40 or 50 mg is continued until progression, patient refusal or unacceptable toxicity (in the clinician's opinion).", 'armGroupLabels': ['VINORELBINA']}] | PrimaryOutcomes: [{'measure': 'TUMOR RESPONSE', 'description': 'STABLE DISEASE', 'timeFrame': '6 MONTHS'}, {'measure': 'number of adverse events', 'description': 'TOLERANCE TO VINORELBINE', 'timeFrame': '6 MONTHS'}] | SecondaryOutcomes: [{'measure': 'PFS', 'description': 'PROGRESSION FREE SURVIVAL', 'timeFrame': '1 year'}, {'measure': 'OS', 'description': 'OVERALLA SURVIVAL', 'timeFrame': '1 YEAR'}]
Title: An Access Delivery Model That Eliminates Barriers to Breast Cancer Care Delivery With Emphasis on the Coordination of Care Within and Between an Outpatient Screening Facility and a Diagnostic and Treatment Center | Condition: Breast Cancer | Keywords: Breast | Summary: | Description: This purpose of this protocol is to systematically evaluate the role of Patient Navigators, non-medical personnel who assist in the coordination of care, for women attending a breast cancer screening clinic in Harlem who are found to have a suspicious result. The concept of patient navigation, developed by Dr. Harold Freeman, has been identified as a promising strategy to reduce disparities in health care for minorities and the underserved. This protocol will evaluate the role of the Patient Navigator in coordinating care for women who are referred to the Ralph Lauren Center for Cancer Care and Prevention (RLCCCP) from the Breast Examination Center of Harlem (BECH). To achieve this, we propose four interrelated tasks. First, we will characterize in detail the specific nature of the activities of the Navigators as they remedy barriers to the receipt of breast cancer care. Secondly, we will determine whether the presence of the Navigator minimizes the percentage of patients with significant delays in receipt of necessary care. Third, we will measure patient satisfaction with care and their perceptions of the value of the Navigator. Finally, we will provide a baseline needs assessment of those (eligible) patients requiring pain and palliation services. Specific Aims: 1. To characterize the role of Patient Navigators by defining the specific tasks and activities they perform in order to eliminate and/or reduce barriers to receipt of cancer care. 2. To evaluate how the presence of a Patient Navigator influences the time intervals from receipt of a suspicious screening mammogram or palpable breast mass to appropriate diagnosis and or treatment. 3. To measure patient's satisfaction with the coordination of care in the presence of a Patient Navigator. 4. To descriptively assess the pain and palliation needs of the population under study. | ArmGroups: [{'label': '1', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Patient Navigation']}] | Interventions:[{'type': 'OTHER', 'name': 'Patient Navigation', 'description': "we will conduct a detailed analysis of how the patient navigators' time is actually utilized by having them record a detailed log categorizing their activities as it relates to the elimination of recognized barriers to care. Second, we will measure the time interval from receipt of a suspicious mammogram to appropriate diagnostic evaluation and or treatment.\n\nWe will measure the number of women who experience diagnostic and or treatment delay and whether the presence of a Patient Navigator enables delivery of coordinated care that avoids delays. Third, we will measure patients' satisfaction with aspects of their care, focusing particularly on care coordination using validated instruments designed for this purpose.", 'armGroupLabels': ['1']}] | PrimaryOutcomes: [{'measure': 'Eval how Navigators spend time & specific tasks undertake to coordinate care.Specificatn of time intervals from receipt of suspicious screening mammogram to receipt of approp diagnostic eval.Pt satisfaction evaluatn take place w/in 1 month of i', 'timeFrame': '5 years'}] | SecondaryOutcomes: N/A
Title: Randomized Phase III Trial Comparing Intensity Modulated Radiotherapy With Integrated Boost to Conventional Radiotherapy With Consecutive Boost in Patients With Breast Cancer After Breast Conserving Surgery | Condition: Breast Cancer | Keywords: IMRT, Integrated boost, adjuvant radiotherapy, breast cancer, breast conserving surgery | Summary: | Description: N/A | ArmGroups: [{'label': 'IMRT + integrated boost', 'type': 'EXPERIMENTAL', 'description': '28 fractions delivering 50.4 Gy to the whole breast and 64.4 Gy to the tumor-bed by an integrated boost', 'interventionNames': ['Radiation: IMRT with an simultaneous integrated boost']}, {'label': 'Conventional RT + sequential boost', 'type': 'OTHER', 'description': 'Conventional radiotherapy of the whole breast in 28 fractions to a dose of 50.4 Gy and a consecutive boost in 8 fractions to a total dose of 66.4 Gy', 'interventionNames': ['Radiation: IMRT with an simultaneous integrated boost']}] | Interventions:[{'type': 'RADIATION', 'name': 'IMRT with an simultaneous integrated boost', 'description': 'IMRT in 28 fractions delivering 50.4 Gy to the whole breast and 64.4 Gy to the tumor-bed', 'armGroupLabels': ['Conventional RT + sequential boost', 'IMRT + integrated boost']}] | PrimaryOutcomes: [{'measure': 'cosmetic results', 'description': 'The cosmetic outcome will be assessed by two independent investigators using the Harvard criteria (excellent, good, fair, poor). Additional parameters to be evaluated are skin color, teleangiectasy, scars, shrinking and asymmetry. Evaluation will also be carried out using a quantitative digitizer scoring system based on standardized photodocumentations of the breast, as described by Vrieling et al.. by calculation of a breast retraction assessment (BRA) score.', 'timeFrame': '2 years'}, {'measure': 'local recurrence rates', 'timeFrame': '5 years'}] | SecondaryOutcomes: [{'measure': 'fraction of patients surviving (overall survival)', 'description': 'ratio of number of patients alive to total number of patients treated', 'timeFrame': '15 years'}, {'measure': 'fraction of patients surviving without tumor recurrence (disease-free survival)', 'description': 'ratio of patients alive without tumor recurrence to total number of patients treated', 'timeFrame': '15 years'}, {'measure': 'quality of life', 'description': 'EORTC questionnaires QLQ-C30 and QLQ-BR23', 'timeFrame': '2 years'}, {'measure': 'occurence of secondary malignancies', 'description': 'ratio of patients with occurence of secondary malignancies to total number of patients treated', 'timeFrame': '15 years'}]
Title: EFFECT OF ENDOSCOPIC TATTOOING WITH CARBON BLACK SUSPENSION ON THE STAGING OF COLON CANCER | Condition: Endoscopic Tattoo of Suspected Colon Cancer | Keywords: | Summary: | Description: Other objectives are: * to assess intraoperative visibility of carbon black tattoo in the tumor region and surrounding tissues * to assess microscopic distribution of carbon ink in the layers of the colonic wall and adjacent tissues * to assess complications related to carbon black tattoo procedure like microscopic fibrosis, micro- or macroscopic scarring, inflammatory reactions * to assess long-term effects of ink injections on control endoscopies at 6 and 12 months * to assess dissection time in tattooed-non tattooed lymphatic tissues | ArmGroups: [{'label': 'Tattoo arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tattoo will be placed by endoscopic submucosal injection of carbon black suspension', 'interventionNames': ['Device: carbon black suspension colonic tattoo injection']}, {'label': 'Control arm', 'type': 'NO_INTERVENTION', 'description': 'Tattoo will not be placed but case will follow standard procedure'}] | Interventions:[{'type': 'DEVICE', 'name': 'carbon black suspension colonic tattoo injection', 'description': 'Examine the SPOT syringe to verify that the pigment is fully suspended. A 23 or 25 G sclerotherapy needle is recommended for this procedure, attach the syringe and prime with SPOT. After injection catheter is primed, manoeuver with the endoscope for optimal injection position and inject tangentially, at a 30-40˚ angle to the mucosa and create a saline bleb to find the submucosal plane prior to injecting SPOT to reduce risk of intramural injection. Document both the depth of scope and anatomic location of each tattoo and the ink consumption as well. Place injection 2-3 cm distal (downstream) of the area of interest. Use 0.5-0.75 mL per injection site and no more than 8 mL per patient. Place SPOT tattoos in 3-4 quadrants around the lumen to increase likelihood of visualisation.', 'armGroupLabels': ['Tattoo arm'], 'otherNames': ['GI supply SPOT endoscopic marker']}] | PrimaryOutcomes: [{'measure': 'Number of tumors visualised from peritoneal cavity/number of tattoos visualised form peritoneal cavity', 'description': 'Distance in cm from tumor wich far carbon injection marked mucosa and adjacent tissues Number of inflammatory cells per field of view in injection site vs. non-injected mucosa Number of dissected total/normal/metastatic/carbon colored lymph nodes', 'timeFrame': '1 year'}] | SecondaryOutcomes: N/A
Title: Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy: a Prospective Randomized Comparative Phase II Trial | Condition: Urothelial Bladder Cancer | Keywords: Urothelial bladder cancer | Summary: | Description: N/A | ArmGroups: [{'label': 'Control arm', 'type': 'NO_INTERVENTION', 'description': 'Standard of care'}, {'label': 'Experimental arm', 'type': 'EXPERIMENTAL', 'interventionNames': ['Radiation: Experimental arm']}] | Interventions:[{'type': 'RADIATION', 'name': 'Experimental arm', 'description': 'Consolidative radiotherapy (pelvic irradiation and/or metastases irradiation) + standard of care +/- previous transurethral resection of bladder tumor', 'armGroupLabels': ['Experimental arm']}] | PrimaryOutcomes: [{'measure': 'Overall Survival', 'timeFrame': '4 years for each patient'}] | SecondaryOutcomes: [{'measure': 'Progression Free Survival', 'timeFrame': '4 years for each patient'}, {'measure': 'Safety will be assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5)', 'timeFrame': '4 years for each patient'}, {'measure': 'Quality of life will be evaluated by the EORTC QLQ-C-30 questionnaire', 'timeFrame': '4 years for each patient'}]
Title: The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity | Condition: Head and Neck Cancer, Oral Mucositis | Keywords: Head Cancer, Neck Cancer, Oral Mucositis, Oral Health, Radiation, Chemoradiation | Summary: | Description: This is a prospective, single blind, two arm, randomized, controlled trial to test the efficacy of an oral care protocol to treat oral mucositis (OM) in patients receiving radiation (RT) or chemoradiation (chemoRT) for head and neck cancer. This trial will also measure salivary proinflammatory cytokines, and evaluate other clinical effects of the intervention during cancer therapy. In addition, oral mucosal swabs will be collected for the future characterization of changes in the microbiome associated with OM severity. Patients will be randomized in a 1:1 ratio to two different oral care protocols within 4 strata defined by type of RT (Proton beam therapy (Protons)) vs intensity-modulated radiation therapy (IMRT) and cancer treatment (RT versus chemoRT). Eligible subjects will be assigned to receive either the Oral Mucosal Deterging and Dental Prophylaxis protocol (OMDP) or a Standard of Care Oral Hygiene protocol (SOC-OH). Prior to randomization, all enrolled subjects will receive a baseline dental prophylaxis and fluoride varnish application prior to start of RT or chemoRT to ensure that all subjects enter the study with comparable oral health. Subjects assigned to OMDP will receive the OMDP Protocol (Oral Mucosal Deterging and Dental Prophylaxis) at weekly intervention visits. Subjects randomized to the SOC-OH will receive oral health instructions following the American Dental Association Guidelines and will have their teeth cleaned (brushed) during weekly intervention visits; no treatment to the oral mucosa will be provided to this group. At each bi-weekly study visit, study assessments will include the collection of saliva and oral mucosal swabs, an oral exam and OM assessment, and the completion of questionnaires. During the course of the study, subjects will attend one baseline visit, up to 9 intervention visits, and a follow-up visit approximately 3 months after completion of RT. Local supportive care, including normal saline rinses, topical anesthetics, mixed medication mouthwashes (e.g. Magic Mouthwash), feeding tubes, and pain management will be allowed according to each recruitment site's standard of care procedures. | ArmGroups: [{'label': 'Standard of Care Oral Hygiene', 'type': 'PLACEBO_COMPARATOR', 'description': 'Standard of Care Oral Hygiene group (SOC-OH): Subjects assigned to SOC-OH will attend weekly oral care visits where they will have their teeth brushed with a soft bristled toothbrush by the interventionist. No treatment to the oral mucosa will be provided to this group as part of the intervention. Subjects will receive oral care instructions and will be asked to follow SOC oral hygiene instructions at home.', 'interventionNames': ['Other: Standard of Care Oral Hygiene']}, {'label': 'Oral Mucosal Deterging and Dental Prophylaxis (OMDP)', 'type': 'EXPERIMENTAL', 'description': 'Oral Mucosal Deterging \\& Dental Prophylaxis (OMDP) protocol: Subjects assigned to OMDP will attend weekly intervention visits during which they will have their teeth cleaned and will receive the OMDP intervention as follows: subjects will receive a professional dental prophylaxis including periodontal surface debridement and deterging of the oral mucosal surfaces. Subjects will be asked to follow OMDP oral hygiene instructions at home.', 'interventionNames': ['Procedure: Oral mucosal deterging and dental prophylaxis']}] | Interventions:[{'type': 'OTHER', 'name': 'Standard of Care Oral Hygiene', 'description': 'Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing.', 'armGroupLabels': ['Standard of Care Oral Hygiene']}, {'type': 'PROCEDURE', 'name': 'Oral mucosal deterging and dental prophylaxis', 'description': 'Subjects will receive a professional dental prophylaxis including periodontal surface debridement \\[a light-touch, gentle form of instrumentation performed with an ultrasonic instrument to promote plaque removal, to facilitate biofilm disruption and endotoxin flushing, but yet with the preservation of the periodontal cementum\\] and deterging of the oral mucosal surfaces.', 'armGroupLabels': ['Oral Mucosal Deterging and Dental Prophylaxis (OMDP)']}] | PrimaryOutcomes: [{'measure': 'Oral mucosal severity', 'description': "Oral mucositis severity as measured by the World Health Organization's Oral Toxicity Scale (WHO OTS); severity is graded 0 through 4, with 4 being the worst. Grade 0 (none), Grade 1 (oral soreness, erythema), Grade 2 (ulceration, solid diet tolerated), Grade 3 (ulceration, liquid diet only), and Grade 4 (nothing by mouth).", 'timeFrame': 'Baseline through 3 months post radiation therapy'}] | SecondaryOutcomes: [{'measure': 'Correlative measures', 'description': 'Salivary cytokines: Levels of Th1/Th2-type cytokines IL10, IL8, IL12p70, TNF alpha, IL4, IL1b, IL2, IL13, IL5, and IFN gamma will be assessed, in addition to levels of gp340.', 'timeFrame': 'Baseline through 3 months post radiation therapy'}, {'measure': 'Oral mucositis assessment', 'description': 'Mucositis will be assessed using the WHO Oral Toxicity Scale (see above) and the NCI Common Terminology Criteria for Adverse Events (grade 1 through 5 with grade 5 being most severe/death)', 'timeFrame': 'Baseline through 3 months post radiation therapy'}, {'measure': 'Duration and time to onset of severe OM', 'description': 'OM severity will be measured by a blinded member of the study team using the WHO OTS (previously described) and the duration and time to onset of severe OM measured in days.', 'timeFrame': 'Baseline through 3 months post radiation therapy'}, {'measure': 'Salivary hypofunction', 'description': 'Changes in saliva flow rate (mL/minute) will be assessed by a 5 minute stimulated saliva collection.', 'timeFrame': 'Baseline through 3 months post radiation therapy'}, {'measure': 'Average mouth and throat soreness', 'description': 'Average mouth and throat soreness (MTS) will be assessed using the validated Oral Mucositis and Daily Questionnaire (Stiff et al.)', 'timeFrame': 'Baseline through 3 months post radiation therapy'}, {'measure': 'QOL and Function', 'description': 'Quality of life and function will be assessed using the validated EORTC-QLQ-C30 for head and neck cancers. This questionnaire assesses general quality of life as well as issues specific to head and neck cancer patients (e.g. difficulty swallowing, pain, dry mouth).', 'timeFrame': 'Baseline through 3 months post radiation therapy'}, {'measure': 'Progression free survival', 'description': 'Progression free survival', 'timeFrame': 'Time from randomization to date of progression or death from any cause, whichever comes first, assessed up to 5 years after completion of RT'}, {'measure': 'Overall survival', 'description': 'Overall survival', 'timeFrame': 'Time from randomization to date of death from any cause, assessed assessed up to 5 years after completion of RT'}]
Title: Molecular Assessment for Gastro-Esophageal Cancer | Condition: Esophageal Cancer, Gastric Cancer, Barrett Esophagus | Keywords: Oncometabolites, Early-stage cancer, Diagnostic testing, Screening | Summary: | Description: N/A | ArmGroups: [{'label': 'Gastro-esophageal cancer group', 'type': 'EXPERIMENTAL', 'description': 'Participants with gastroesophageal cancer providing a breath and blood sample for biomarker identification', 'interventionNames': ['Diagnostic Test: Breath analysis', 'Diagnostic Test: Blood analysis']}, {'label': "Barrett's esophagus group", 'type': 'ACTIVE_COMPARATOR', 'description': "Participants with Barrett's esophagus providing a breath and blood sample for biomarker identification", 'interventionNames': ['Diagnostic Test: Breath analysis', 'Diagnostic Test: Blood analysis']}, {'label': 'Healthy controls', 'type': 'ACTIVE_COMPARATOR', 'description': 'Healthy controls providing a breath and blood sample for biomarker identification', 'interventionNames': ['Diagnostic Test: Breath analysis', 'Diagnostic Test: Blood analysis']}] | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'Breath analysis', 'description': 'Detection of proteins and volatile organic compounds (oncometabolites) in the exhaled breath', 'armGroupLabels': ["Barrett's esophagus group", 'Gastro-esophageal cancer group', 'Healthy controls']}, {'type': 'DIAGNOSTIC_TEST', 'name': 'Blood analysis', 'description': 'Detection of proteins and circulating tumor DNA (oncometabolites) in the peripheral blood', 'armGroupLabels': ["Barrett's esophagus group", 'Gastro-esophageal cancer group', 'Healthy controls']}] | PrimaryOutcomes: [{'measure': 'Identification of the concentrations of oncometabolites', 'description': 'Identify the concentrations of cancer-related metabolites (oncometabolites) in the exhaled breath and blood compared to healthy controls', 'timeFrame': 'year 1-2'}] | SecondaryOutcomes: [{'measure': 'Assessment of incidence of early-stage cancer', 'description': "Distinguish early-stage gastro-oesophageal cancer from Barrett's esophagus and healthy controls based on sensitivity, specificity and accuracy of the oncometabolite concentration", 'timeFrame': 'year 2-5'}, {'measure': 'Assessment of incidence of therapy response', 'description': 'Predict and assess therapy response prior to surgery, based on sensitivity, specificity and accuracy of the oncometabolite concentration', 'timeFrame': 'year 2-5'}, {'measure': 'Assessment of percentage change of therapy response', 'description': 'Assess changes in the concentrations of the oncometabolites related to treatment.', 'timeFrame': 'year 2-5'}, {'measure': 'Assessment of incidence of recurrence', 'description': 'Predict and assess recurrence, based on sensitivity, specificity and accuracy of the oncometabolite concentration', 'timeFrame': 'year 2-5'}]
Title: Phase IB, Open-Label, Multicenter, Dose-Escalation Study Followed by an Extension Phase to Evaluate the Safety, Pharmacokinetics and Activity of RO5479599, a Glycoengineered Antibody Against HER3, Administered in Combination With Pertuzumab and Paclitaxel in Patients With Metastatic Breast Cancer Expressing HER3 & HER2 Protein | Condition: Breast Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Lumretuzumab Dose Escalation', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive escalating doses of lumretuzumab starting at 1000 mg IV (on Day 1, except Cycle 1 where lumretuzumab will be administered on Day 2) along with paclitaxel 80 mg/m\\^2 IV (on Days 1, 8, and 15), and pertuzumab 840 mg IV (on Day 1) initial dose followed by 420 mg IV, in each 21-day cycle. Participants will be treated until disease progression, unacceptable toxicities, and withdrawal from treatment for other reasons or death.', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Pertuzumab', 'Drug: Lumretuzumab']}, {'label': 'EPC1: Lumretuzumab (Prior Chemotherapy)', 'type': 'EXPERIMENTAL', 'description': 'Extension phase Cohort 1 (EPC1): Participants will receive lumretuzumab 1000 mg IV (on Day 1) along with paclitaxel 80 mg/m\\^2 IV (on Days 1, 8, and 15), and pertuzumab 840 mg IV (on Day 1) initial dose followed by 420 mg IV, in each 21-day cycle. Participants will be treated until disease progression, unacceptable toxicities, and withdrawal from treatment for other reasons or death.', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Pertuzumab', 'Drug: Lumretuzumab']}, {'label': 'EPC2: Lumretuzumab (Without Prior Chemotherapy)', 'type': 'EXPERIMENTAL', 'description': 'Extension phase Cohort 2 (EPC2): Participants will receive lumretuzumab 2000 mg IV (on Day 1) along with paclitaxel 80 mg/m\\^2 IV (on Days 1, 8, and 15), and pertuzumab 420 mg IV (on Day 1), in each 21-day cycle. Participants will be treated until disease progression, unacceptable toxicities, and withdrawal from treatment for other reasons or death. Only participants with no prior chemotherapy for metastatic disease and/or a maximum of only one prior chemotherapy regimen in adjuvant or neoadjuvant setting will be enrolled in this cohort.', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Pertuzumab', 'Drug: Lumretuzumab']}] | Interventions:[{'type': 'DRUG', 'name': 'Paclitaxel', 'description': 'Paclitaxel IV infusion will be administered as per schedule described in individual arm.', 'armGroupLabels': ['EPC1: Lumretuzumab (Prior Chemotherapy)', 'EPC2: Lumretuzumab (Without Prior Chemotherapy)', 'Lumretuzumab Dose Escalation']}, {'type': 'DRUG', 'name': 'Pertuzumab', 'description': 'Pertuzumab IV infusion will be administered as per schedule described in individual arm.', 'armGroupLabels': ['EPC1: Lumretuzumab (Prior Chemotherapy)', 'EPC2: Lumretuzumab (Without Prior Chemotherapy)', 'Lumretuzumab Dose Escalation'], 'otherNames': ['Perjeta']}, {'type': 'DRUG', 'name': 'Lumretuzumab', 'description': 'Lumretuzumab will be administered as per schedule described in individual arm.', 'armGroupLabels': ['EPC1: Lumretuzumab (Prior Chemotherapy)', 'EPC2: Lumretuzumab (Without Prior Chemotherapy)', 'Lumretuzumab Dose Escalation'], 'otherNames': ['RO5479599; RG7116']}] | PrimaryOutcomes: [{'measure': 'Percentage of Participants With Dose-Limiting Toxicities (DLTs)', 'timeFrame': 'Day 1 up to Day 21'}, {'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': 'Baseline up to approximately 39 months'}, {'measure': 'Percentage of Participants With Anti-Human Antibodies (HAHAs) to lumretuzumab [RO5479599]', 'timeFrame': 'Pre-infusion (Pr-I) (0 hour [h]) on Day 1 (D1) of each Cycle (Cy) up to approximately 39 months (assessed at Pr-I on D1 of each treatment Cy up to 28 and 42-45 days after last infusion [up to approximately 39 months overall]) (1 Cy = 21 days)'}, {'measure': 'Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of lumretuzumab [RO5479599]', 'timeFrame': 'Pr-I (0 Hr) & 3, 24, 72, 168, 264, 312, 432, & 480 Hr post D1 infusion (infusion duration = 1.5-2 hours) of Cy4, 8 & post D2 infusion of Cy1; D1 of all other cycles up to 28 and 42-45 days after last dose (up to approximately 39 months) (1 Cy = 21 days)'}, {'measure': 'Pharmacokinetics: Maximum Serum Concentration (Cmax) of lumretuzumab [RO5479599]', 'timeFrame': 'Pr-I (0 Hr) & 3, 24, 72, 168, 264, 312, 432, & 480 Hr post D1 infusion (infusion duration = 1.5-2 hours) of Cy4, 8 & post D2 infusion of Cy1; D1 of all other cycles up to 28 and 42-45 days after last dose (up to approximately 39 months) (1 Cy = 21 days)'}, {'measure': 'Pharmacokinetics: Trough Serum Concentration (Ct) of lumretuzumab [RO5479599]', 'timeFrame': 'Pr-I (0 h) on D1 of each cycles beginning from Cy 2 up to 28 and 42-45 days after last infusion (up to approximately 39 months) (1 Cy = 21 days)'}, {'measure': 'Pharmacokinetics: Time to Reach Maximum Serum Concentration (tmax) of lumretuzumab [RO5479599]', 'timeFrame': 'Pr-I (0 h) & 3, 24, 72, 168, 264, 312, 432, & 480 Hr post D1 infusion (infusion duration = 1.5-2 h) of Cy4, 8 & post D2 infusion of Cy1; D1 of all other cycles up to 28 and 42-45 days after last dose (up to approximately 39 months) (1 Cy = 21 days)'}, {'measure': 'Pharmacokinetics: Clearance (CL) of lumretuzumab [RO5479599]', 'timeFrame': 'Pr-I (0 h) & 3, 24, 72, 168, 264, 312, 432, & 480 h post D1 infusion (infusion duration = 1.5-2 h) of Cy4, 8 & post D2 infusion of Cy1; D1 of all other cycles up to 28 and 42-45 days after last dose (up to approximately 39 months) (1 Cy = 21 days)'}, {'measure': 'Pharmacokinetics: Volume of distribution (V) of lumretuzumab [RO5479599]', 'timeFrame': 'Pr-I (0 h) & 3, 24, 72, 168, 264, 312, 432, & 480 h post D1 infusion (infusion duration = 1.5-2 h) of Cy4, 8 & post D2 infusion of Cy1; D1 of all other cycles up to 28 and 42-45 days after last dose (up to approximately 39 months) (1 Cy = 21 days)'}, {'measure': 'Pharmacokinetics: Accumulation Ratio of lumretuzumab [RO5479599]', 'timeFrame': 'Pr-I (0 h) & 3, 24, 72, 168, 264, 312, 432, & 480 h post D1 infusion (infusion duration = 1.5-2 h) of Cy4, 8 & post D2 infusion of Cy1; D1 of all other cycles up to 28 and 42-45 days after last dose (up to approximately 39 months) (1 Cy = 21 days)'}, {'measure': 'Pharmacokinetics: Elimination Half-Life (t1/2) of lumretuzumab [RO5479599]', 'timeFrame': 'Pr-I (0 h) & 3, 24, 72, 168, 264, 312, 432, & 480 h post D1 infusion (infusion duration = 1.5-2 h) of Cy4, 8 & post D2 infusion of Cy1; D1 of all other cycles up to 28 and 42-45 days after last dose (up to approximately 39 months) (1 Cy = 21 days)'}, {'measure': 'Pharmacokinetics: Serum Concentration at the Time of Tumor Progression (Cprog) of lumretuzumab [RO5479599]', 'timeFrame': 'At the time of tumor progression (up to approximately 39 months)'}, {'measure': 'Pharmacokinetics: Serum Concentration at the Time of Tumor Response (Complete response [CR]/Partial Response [PR]) of lumretuzumab [RO5479599]', 'timeFrame': 'At the time of tumor progression (up to approximately 39 months)'}, {'measure': 'Pharmacokinetics: Serum Concentration at the Time of DLT of lumretuzumab [RO5479599]', 'timeFrame': 'At the time of DLT (up to 21 days)'}, {'measure': 'Pharmacokinetics: Serum Concentration at the Time of Tumor and Skin Biopsy (Cb) of lumretuzumab [RO5479599]', 'timeFrame': 'At the time of tumor/skin biopsy (up to approximately 39 months)'}, {'measure': 'Pharmacokinetics: Serum Concentration at the Time of Infusion-Related Reactions (IRR) of lumretuzumab [RO5479599]', 'timeFrame': 'At the time of IRR (up to approximately 39 months)'}, {'measure': 'Recommended Phase II Dose of lumretuzumab [RO5479599]', 'timeFrame': 'Day 1 up to Day 21'}] | SecondaryOutcomes: [{'measure': 'Percentage of Participants With Best Overall Response of CR or PR (Objective Response) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1) Criteria', 'timeFrame': 'Baseline up to documented disease progression (PD) or death, whichever occurs first up to approximately 39 months (assessed at baseline thereafter every 9 weeks up to 28 days after last infusion or early discontinuation)'}, {'measure': 'Percentage of Participants With Best Overall Response of CR or PR or SD (Disease Control), Assessed Using RECIST V1.1 Criteria', 'timeFrame': 'Baseline up to documented PD or death, whichever occurs first up to approximately 39 months (assessed at baseline thereafter every 9 weeks up to 28 days after last infusion or early discontinuation)'}, {'measure': 'Duration of Response, Assessed Using RECIST V1.1 Criteria', 'timeFrame': 'From first confirmed documented objective response (CR/PR) up to documented PD or death, whichever occurs first up to approximately 39 months (assessed at baseline thereafter every 9 weeks up to 28 days after last infusion or early discontinuation)'}, {'measure': 'Progression-Free Survival Assessed Using RECIST V1.1 Criteria', 'timeFrame': 'Baseline up to documented PD or death, whichever occurs first up to approximately 39 months (assessed at baseline thereafter every 9 weeks up to 28 days after last infusion or early discontinuation)'}, {'measure': 'Overall Survival', 'timeFrame': 'Baseline up to death (up to approximately 39 months)'}]
Title: Telephone-Based Mindfulness CBT for Patients in Community Settings With Advanced Cancer | Condition: Advanced Cancer | Keywords: | Summary: | Description: Individuals with advanced cancers often experience significant symptom burden including pain, fatigue, and psychological distress, all while facing acceptance of the meaning of their advanced disease. Evidence-based behavioral interventions have been developed to alleviate this multiple symptom burden but are understudied and the treatments that are available are often not easily accessed by patients most in need in community-based settings. The current study examines the feasibility and acceptability of an open trial of mindfulness-based Cognitive Behavioral Therapy intervention delivered via telephone to men and women age 21 and older with a diagnosis of advanced cancer. Potential participants (N=35) will be recruited via letter from their oncologist at community-based clinics (N=18) and those served at the Duke Cancer Institute in Durham who live more than 60 miles away (N=17). Following informed consent, participants will be asked to complete assessments (e..g., examining their pain, anxiety, depression, fatigue, and engagement in valued activity). They will then receive 4 weekly 50-minute telephone sessions with a study therapist and practice skills learned in session at home. After completing the 4 sessions, they will complete a post-treatment assessment. Data analyses will examine the feasibility and acceptability of the study by assessing participant engagement, and will examine changes in key psychological variables (e.g., pain, anxiety, depression, fatigue, and valued activity) from baseline to post-treatment. There is minimal risk related to confidentiality of data and the possibility of feeling uncomfortable in the study. All study contacts will be conducted by trained study staff and supervised by the PI; a licensed clinical psychologist. Participant tracking data will be stored online via REDCAP and accessed only by study staff, participant assessment data will be collected and stored online via REDCap, and audio recordings of study telephone sessions will be stored on Duke servers. | ArmGroups: [{'label': 'Cognitive Behavioral Mutli-Symptom management(CBT)', 'type': 'OTHER', 'description': 'Learn to manage distress, fatigue, and/or pain via Cognitive Behavioral Multi-Symptom Management(CBT). Four sessions will be conducted each session is approximately one hour.', 'interventionNames': ['Behavioral: Cognitive Behavioral Mutli-Symptom management(CBT)']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Cognitive Behavioral Mutli-Symptom management(CBT)', 'description': 'Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions.', 'armGroupLabels': ['Cognitive Behavioral Mutli-Symptom management(CBT)']}] | PrimaryOutcomes: [{'measure': 'Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment.', 'description': 'Feasibility will be shown by no more than 20% study attrition.', 'timeFrame': '8 weeks'}, {'measure': 'Acceptability, as measured by Client Satisfaction Questionnaire 10-item version', 'description': 'Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the CBT protocol (mean score of 7) on the CSQ', 'timeFrame': '8 weeks'}, {'measure': 'Feasibility as measured by study accrual by meeting recruitment goal', 'description': 'Feasibility will be shown by meeting targeted study accrual (N=35) in the 12-month study period.', 'timeFrame': '8 weeks'}, {'measure': 'Feasibility as measured by adherence to the study protocol by number of intervention sessions completed by the participant', 'description': 'Feasibility will be shown by adherence to at least 75% of the intervention sessions (3/4)', 'timeFrame': '8 weeks'}] | SecondaryOutcomes: [{'measure': 'Change in pain', 'description': 'Pain will be assessed with the Brief Pain Inventory (BPI)', 'timeFrame': 'Baseline and 8 weeks'}, {'measure': 'Change in fatigue', 'description': 'Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form.', 'timeFrame': 'Baseline and 8 weeks'}, {'measure': 'Change in depression', 'description': 'The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)', 'timeFrame': 'Baseline and 8 weeks'}, {'measure': 'Change in Mindfulness', 'description': 'Acceptance and mindfulness will be assessed using the Acceptance and Action Questionnaire-II, the most widely used measure of mechanism of change in ACT-based medical treatment studies.', 'timeFrame': 'Baseline and 8 weeks'}, {'measure': 'Change in anxiety', 'description': 'The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)', 'timeFrame': 'Baseline and 8 weeks'}, {'measure': 'Change in Acceptance', 'description': 'Acceptance and mindfulness will be assessed using the Acceptance and Action Questionnaire-II, the most widely used measure of mechanism of change in ACT-based medical treatment studies.', 'timeFrame': 'Baseline and 8 weeks'}]
Title: Assessment for Long-Term Cardiovascular Impairment Associated With Trastuzumab Cardiotoxicity in HER2-Positive Breast Cancer Survivors | Condition: Trastuzumab Cardiotoxicity, HER2-Positive Breast Cancer Survivors | Keywords: Cardiovascular Impairment, 15-258 | Summary: | Description: N/A | ArmGroups: [{'label': 'treated with trastuzmab no cardiac effects', 'interventionNames': ['Device: 2D Echocardiogram', 'Device: Cardiopulmonary exercise testing and post-CPET cardiac function']}, {'label': 'treated with trastuzmab with cardiac effects', 'interventionNames': ['Device: 2D Echocardiogram', 'Device: Cardiopulmonary exercise testing and post-CPET cardiac function']}, {'label': 'healthy volunteers no cancer treatment', 'interventionNames': ['Device: 2D Echocardiogram', 'Device: Cardiopulmonary exercise testing and post-CPET cardiac function']}] | Interventions:[{'type': 'DEVICE', 'name': '2D Echocardiogram', 'description': 'All patients will undergo a two-dimensional echocardiogram with speckle tracking strain analysis within the MSK echocardiography laboratory.', 'armGroupLabels': ['healthy volunteers no cancer treatment', 'treated with trastuzmab no cardiac effects', 'treated with trastuzmab with cardiac effects']}, {'type': 'DEVICE', 'name': 'Cardiopulmonary exercise testing and post-CPET cardiac function', 'description': 'To determine VO2peak, an electronic motorized treadmill test with 12-lead ECG monitoring (Mac ® 5000, GE Healthcare) will be performed by certified exercise physiologists.', 'armGroupLabels': ['healthy volunteers no cancer treatment', 'treated with trastuzmab no cardiac effects', 'treated with trastuzmab with cardiac effects']}] | PrimaryOutcomes: [{'measure': 'cardiac function', 'description': 'Exercise capacity will be assessed by CPET, and echocardiographic images will be obtained immediately after CPET to evaluate contractile reserve.', 'timeFrame': '2 years'}] | SecondaryOutcomes: N/A
Title: International Multicenter Phase I Trial of Hydroxyurea in Combination With Dose-Intense Temozolomide in Recurrent Glioblastoma | Condition: Glioma, Glioblastoma | Keywords: Glioma, Recurrent glioma, Glioblastoma multiforme, Recurrent Glioblastoma multiforme, Hydroxyurea, Temozolomide | Summary: | Description: N/A | ArmGroups: [{'label': 'Daily hydroxyurea and temozolomide', 'type': 'EXPERIMENTAL', 'description': 'Hydroxyurea and temozolomide will be administered every 4 weeks, with 28 consecutive days defined as a treatment cycle. Treatment will be administered on an outpatient basis. Oral hydroxyurea (dose specified by the Dose Cohort below) and oral temozolomide (50 mg/m2/day) will be administered daily in 28-day cycles for 12 cycles or until unacceptable toxicity, intolerance, progressive disease, or withdrawal of consent. Patients will be treated in dose cohorts of 3 with each cohort receiving a specific daily dose assignment of hydroxyurea.\n\nAll patients in the study will receive temozolomide at 50 mg/m2/day ("dose-intense" schedule). The starting dose level for hydroxyurea will be 200 mg daily (QD) up to a maximum of 2000mg hydroxyurea a day.', 'interventionNames': ['Drug: Hydroxyurea', 'Drug: Temozolomide']}] | Interventions:[{'type': 'DRUG', 'name': 'Hydroxyurea', 'description': '147-94-4/HYDROXYCARBAMIDE/HYDROXYCARBAMIDE/based on myeloproliferative disorders (MPD) record: SUB08076MIG', 'armGroupLabels': ['Daily hydroxyurea and temozolomide'], 'otherNames': ['Hydroxycarbamide']}, {'type': 'DRUG', 'name': 'Temozolomide', 'description': '85622-93-1 /TEMOZOLOMIDE/TEMOZOLOMIDE/based on myeloproliferative disorders (MPD) record: SUB10889MIG', 'armGroupLabels': ['Daily hydroxyurea and temozolomide'], 'otherNames': ['Temodar']}] | PrimaryOutcomes: [{'measure': 'Maximal tolerated dose (MTD) hydroxyurea in combination with dose intense temozolomide', 'description': 'MTD', 'timeFrame': '12 months'}] | SecondaryOutcomes: N/A
Title: Strain-based vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention Strategy in Patients With Breast Cancer Who Treated With Adjuvant Trastuzumab | Condition: Cardiotoxicity, Breast Cancer, Prevention, Adjuvant, Trastuzumab | Keywords: | Summary: | Description: Despite the left ventricular global longitudinal strain (GLS) enables early prediction of trastuzumab-related cardiomyopathy, its clinical application has been hampered due to the lack of appropriate evaluation and treatment strategies. Therefore, we aimed to evaluate the effect of early intervention strategy (GLS-based cardiotoxicity monitoring and administration of candesartan) by comparing with conventional intervention strategy (left ventricular ejection fraction-based cardiotoxicity monitoring and administration of candesartan) in breast cancer patients who treated with adjuvant trastuzumab. | ArmGroups: [{'label': 'Conventional Cardiac intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'Starting candesartan in patients with left ventricular ejection fraction (LVEF) between 45% and 50% by echocardiogram.', 'interventionNames': ['Drug: Candesartan']}, {'label': 'Early Cardiac intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'Starting candesartan in patients with decreased myocardial strain below 18% regardless of LVEF by echocardiogram.', 'interventionNames': ['Drug: Candesartan']}] | Interventions:[{'type': 'DRUG', 'name': 'Candesartan', 'description': 'If GLS decreased less than 18% or LVEF decreased to 45-50% during the treatment of adjuvant trastuzumab, start candesartan medication.', 'armGroupLabels': ['Conventional Cardiac intervention', 'Early Cardiac intervention']}] | PrimaryOutcomes: [{'measure': 'Left ventricular ejection fraction (LVEF)', 'description': 'Maximum change in LVEF', 'timeFrame': 'at months 3,6,9,12,18'}] | SecondaryOutcomes: [{'measure': 'Overt chemotherapy induced cardiotoxicity', 'description': 'LVEF \\< 45%, decline in LVEF by \\>10% to a value to 45-49%, symptomatic congestive heart failure', 'timeFrame': 'any time'}, {'measure': 'Changes in cardiac biomarker', 'description': 'NT-pro BNP, cardiac troponin', 'timeFrame': 'at months 3,6,9,12,18'}]
Title: Histotripsy (HistoSonics®) for Liver Tumours: a Phase II Safety and Efficacy Study | Condition: Liver Tumour | Keywords: liver tumour | Summary: | Description: N/A | ArmGroups: [{'label': 'Histotripsy', 'type': 'OTHER', 'description': 'Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures', 'interventionNames': ['Radiation: Histotripsy']}] | Interventions:[{'type': 'RADIATION', 'name': 'Histotripsy', 'description': 'Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures. It works by using high-intensity ultrasound waves to create microscopic bubbles within the tumour tissue. These bubbles rapidly expand and collapse, generating shock waves that disrupt the tissue. The technique is highly precise and can be targeted to specific areas of the liver, allowing for selective destruction of tumour cells while minimizing damage to healthy tissue.', 'armGroupLabels': ['Histotripsy'], 'otherNames': ['HistoSonics']}] | PrimaryOutcomes: [{'measure': 'Changes in tumour features', 'description': 'Changes in tumour size and volume before and after intervention', 'timeFrame': 'up to 36 months'}, {'measure': 'Post procedure adverse events and complication', 'description': 'Post procedure adverse events and complication', 'timeFrame': 'The whole duration of hospital stay, normally 3 days on average'}] | SecondaryOutcomes: N/A
Title: Phase II Study of Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Patients With Metastatic Breast Cancer | Condition: Metastatic Breast Cancer | Keywords: Metastatic Breast Cancer, Her-2 negative Breast Cancer, Avastin, FOLFOX regimen | Summary: | Description: Anthracyclines and taxanes are the most frequently used agents for breast cancer,both in adjuvant and in first-line metastatic settings.For the patients who do not respond or relapse early after the administration of a taxane or anthracycline regimen,it is clearly needed to explore new combinations and schedules of drugs.Oxaliplatin has shown very promising activity in MBC either in monotherapy or in combination with 5-fluorouracil(5-FU) with or without leucovorin (LV). Avastin is a target therapy with proven efficacy in the treatment of MBC. Avastin plus FOLFOX regimen showed synergetic effet and been used as the standard trial in metastatic colorectal cancer patients. Based on the above reason, we initiate this phase II study to evaluate efficacy and safety of avastin plus modified FOLFOX6 regimen in HER-2 negative metastatic breast cancer patients. | ArmGroups: [{'label': 'Avastin + mFOLFOX6', 'type': 'EXPERIMENTAL', 'description': 'Avastin plus FOLFOX6 regimen in the management of her-2 negative breast cancer patients.', 'interventionNames': ['Drug: Avastin + mFOLFOX6']}] | Interventions:[{'type': 'DRUG', 'name': 'Avastin + mFOLFOX6', 'description': 'mFOLFOX6 regimen, repeated every 2 weeks: Oxaliplatin 85 mg/m2，ivgtt； Leucovorin 400 mg/m2,ivgtt； 5-FU 400 mg/m2，iv，and then 2400 mg/m2，civ46h；\n\nAvastin: Avastin 5mg/kg q2w or 7.5mg/kg q3w', 'armGroupLabels': ['Avastin + mFOLFOX6'], 'otherNames': ['Avastin', 'Oxaliplatin', 'Leucovorin', '5-FU']}] | PrimaryOutcomes: [{'measure': 'Progression free survival', 'timeFrame': 'response evaluation every two cycles'}] | SecondaryOutcomes: [{'measure': 'Number of adverse events', 'timeFrame': '8 weeks'}]
Title: A PHASE 1 STUDY TO EVALUATE THE EFFECT OF HEPATIC IMPAIRMENT ON THE PHARMACOKINETICS AND SAFETY OF LORLATINIB IN ADVANCED CANCER PATIENTS | Condition: Advanced Cancers | Keywords: hepatic impairment, lorlatinib, cancer, pharmacokinetic, Lung cancer | Summary: | Description: This will be a Phase 1, open label, multi center, multiple dose, non randomized, Phase 1 clinical trial of lorlatinib in advanced cancer patients with varying degrees of hepatic impairment and necessary age , weight , and gender matched prospect normal hepatic function patients. This study is intended to evaluate the potential effect of hepatic impairments on the PK and safety of lorlatinib after daily administration of lorlatinib and to provide dosing recommendation for patients with varied degree of hepatic impairment if possible. Patients in the study will be assigned to different groups (A1, normal liver function, control for group B; A2, normal liver function, control for group C; B, mild hepatic impairment; C, moderate hepatic impairment; D, severe hepatic impairment) according to their liver function. The enrollment of approximately 76 advanced cancer patients is anticipated in this study in order to have 8 PK-evaluable patients in each of Groups A1, A2, B and C, and 6 PK-evaluable patients in Group D for final statistical analysis. Evaluable patients are those who complete the planned PK sample collection on Cycle 2 Day 1 and have no lorlatinib dose modification until completion of Cycle 2 Day 1 PK evaluation. Patients who are not evaluable for PK will be replaced. Each patient will be treated with repeated oral once daily doses of lorlatinib in 21-day cycles until disease progression, patient refusal, or unacceptable toxicity occurs. The dose schedule may be modified as necessary for individual patients according to tolerability. | ArmGroups: [{'label': 'Group A1 Normal hepatic function', 'type': 'ACTIVE_COMPARATOR', 'description': 'continued daily administration of lorlatinib in patients with normal hepatic function', 'interventionNames': ['Drug: lorlatinib']}, {'label': 'Group A2 Normal hepatic function', 'type': 'ACTIVE_COMPARATOR', 'description': 'continued daily administration of lorlatinib in patients with normal hepatic function', 'interventionNames': ['Drug: lorlatinib']}, {'label': 'Group B mild hepatic impairment', 'type': 'EXPERIMENTAL', 'description': 'continued daily administration of lorlatinib in patients with mild hepatic impairment', 'interventionNames': ['Drug: lorlatinib']}, {'label': 'Group C moderate hepatic impairment', 'type': 'EXPERIMENTAL', 'description': 'continued daily administration of lorlatinib in patients with moderate hepatic impairment', 'interventionNames': ['Drug: lorlatinib']}, {'label': 'Group D severe hepatic impairment', 'type': 'EXPERIMENTAL', 'description': 'continued daily administration of lorlatinib in patients with severe hepatic impairment', 'interventionNames': ['Drug: lorlatinib']}] | Interventions:[{'type': 'DRUG', 'name': 'lorlatinib', 'description': 'continued daily administration of 100 mg lorlatinib', 'armGroupLabels': ['Group A1 Normal hepatic function']}, {'type': 'DRUG', 'name': 'lorlatinib', 'description': 'continued daily administration of lorlatinib at the dose level same as Group C for the first 22 days and 100 mg QD afterwards', 'armGroupLabels': ['Group A2 Normal hepatic function']}, {'type': 'DRUG', 'name': 'lorlatinib', 'description': 'continued daily administration of 100 mg QD lorlatinib', 'armGroupLabels': ['Group B mild hepatic impairment']}, {'type': 'DRUG', 'name': 'lorlatinib', 'description': 'continued daily administration of lorlatinib at 50 mg QD initially and may be adjusted based on PK and safety results from the initial several patients', 'armGroupLabels': ['Group C moderate hepatic impairment']}, {'type': 'DRUG', 'name': 'lorlatinib', 'description': 'continued daily administration of lorlatinib at the dose level determined based on preliminary PK and safety results from first several patients in Group C', 'armGroupLabels': ['Group D severe hepatic impairment']}] | PrimaryOutcomes: [{'measure': 'Area Under Plasma Lorlatinib Concentration-Time Curve From Time 0 to Dosing Interval of 24 Hours (AUC24) at Steady State On Cycle 2 Day 1', 'description': 'AUC24 was defined as area under the plasma concentration time profile during 1 dosing interval (24 hours).', 'timeFrame': 'Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Observed Maximal Plasma Concentration (Cmax) at Steady State on Cycle 2 Day 1', 'description': 'Cmax was defined as maximum plasma concentration and was observed directly from data.', 'timeFrame': 'Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}] | SecondaryOutcomes: [{'measure': 'Number Of Patients Experienced Treatment Emergent Adverse Event Assessed by Investigator', 'description': 'An Adverse event (AE) was any untoward medical occurrence in a participant. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or that was considered to be an important medical event. AEs were graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The grades were defined as follows: Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE. The focus of AE summaries was on treatment-emergent AE (TEAE). An AE was considered TEAE if the event occurred during the on-treatment period.', 'timeFrame': 'From Screening (within 28 days prior to Cycle 1 Day 1) through and including at least 28 days after after the last lorlatinib dose. The duration is approximately 42 days.'}, {'measure': 'Objective Response Rate (ORR)', 'description': 'ORR was defined as the percentage of participants with a best overall confirmed response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 relative to the response-evaluable population.', 'timeFrame': 'Baseline up to approximately 1 year'}, {'measure': 'Duration of Response (DR)', 'description': 'DR was measured from the date that an objective tumor response (CR or PR) was first documented (whichever occurred first) to date of objective tumor progression or death due to any cause, whichever occurred first.', 'timeFrame': 'Baseline up to approximately 1 year'}, {'measure': 'Lorlatinib Area Under Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) After Single Dose on Cycle 1 Day 1', 'description': 'AUClast was defined as area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast)', 'timeFrame': 'Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'The Time of The Last Quantifiable Concentration (Tlast) of Lorlatinib After Single Dose on Cycle 1 Day 1', 'description': 'Tlast was defined as the time of the last quantifiable concentration.', 'timeFrame': 'Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'The Time to Cmax (Tmax) of Lorlatinib After Single Dose on Cycle 1 Day 1', 'description': 'Tmax was defined as time for Cmax.', 'timeFrame': 'Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Observed Minimal Plasma Concentration (Cmin) at Steady State On Cycle 2 Day 1', 'description': 'Cmin was defined as minimum plasma concentration and was observed directly from data.', 'timeFrame': 'Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Plasma Lorlatinib AUClast at Steady State On Cycle 2 Day 1', 'description': 'AUClast was defined as area under the plasma concentration time profile from time 0 to the time of Clast.', 'timeFrame': 'Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Plasma Lorlatinib Tlast at Steady State On Cycle 2 Day 1', 'description': 'Tlast was defined as the time of the last quantifiable concentration.', 'timeFrame': 'Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Apparent Clearance (CL/F) at Steady State On Cycle 2 Day 1', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as Dose/AUC24 at steady-state.', 'timeFrame': 'Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Plasma Lorlatinib Metabolite AUC24 at Steady State', 'description': 'AUC24 was defined as area under the plasma concentration time profile during one dosing interval (24 hours).', 'timeFrame': 'Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Plasma Lorlatinib Metabolite AUClast After Single Dose', 'description': 'AUClast was defined as area under the plasma concentration time profile from time 0 to the time of Clast.', 'timeFrame': 'Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Plasma Lorlatinib Metabolite AUClast at Steady State', 'description': 'AUClast was defined as area under the plasma concentration time profile from time 0 to the time of Clast.', 'timeFrame': 'Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Plasma Lorlatinib Metabolite Cmax After Single Dose', 'description': 'Cmax was defined as maximum plasma concentration and was observed directly from data.', 'timeFrame': 'Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Plasma Lorlatinib Metabolite Cmax at Steady State', 'description': 'Cmax was defined as maximum plasma concentration and was observed directly from data.', 'timeFrame': 'Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Plasma Lorlatinib Metabolite Tlast After Single Dose', 'description': 'Tlast was defined as the time of the last quantifiable concentration.', 'timeFrame': 'Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Plasma Lorlatinib Metabolite Tlast at Steady State', 'description': 'Tlast was defined as the time of the last quantifiable concentration.', 'timeFrame': 'Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Metabolite Ratio of Lorlatinib Metabolite for AUC24 (MRAUC24) at Steady State on Cycle 2 Day 1', 'description': 'MRAUC24 was defined as metabolite ratio of lorlatinib metabolite for AUC24.', 'timeFrame': 'Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Metabolite Ratio of Lorlatinib Metabolite for AUClast (MRAUClast) at Steady State on Cycle 2 Day 1', 'description': 'MRAUClast was defined as metabolite ratio of lorlatinib metabolite for AUClast.', 'timeFrame': 'Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Metabolite Ratio of Lorlatinib Metabolite for Cmax (MRCmax) at Steady State on Cycle 2 Day 1', 'description': 'MRCmax was defined as metabolite ratio of lorlatinib metabolite for AUClast.', 'timeFrame': 'Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}, {'measure': 'Metabolite Ratio of Lorlatinib Metabolite for AUClast (MRAUClast) at Steady State on Cycle 1 Day 1', 'description': 'MRAUClast was defined as metabolite ratio of lorlatinib metabolite for AUClast.', 'timeFrame': 'Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.'}]
Title: Phase II, Randomized Study of Patients With Rising PSA at High-Risk of Progression After Primary Therapy to Assess the Clinical and Molecular Efficacy of the Enzastaurin - Bicalutamide Combination to Suppress the Androgen Receptor Without Testosterone Ablation | Condition: Prostate Cancer | Keywords: stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, recurrent prostate cancer | Summary: | Description: OBJECTIVES: Primary * To compare the two regimens on the proportion of patients with undetectable prostate-specific antigen (PSA) level (\< 0.2 ng/mL) at 44 weeks. Secondary * To assess the proportion of patients with PSA decline \> 85% at 44 weeks on the combination therapy arm compared to that of bicalutamide monotherapy arm. * To assess the distribution of best PSA response in each study arm. * To assess the time to PSA progression and the time to PSA nadir in each arm of the study. * To assess the duration of PSA response in each arm of the study. * To characterize the PSA slope before, during, and after treatment. * To evaluate the safety and tolerability of enzastaurin hydrochloride in this patient population. * To determine whether Gleason score or prior hormonal therapy has any effect on PSA response to treatment. OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≤ 6 vs 7 vs 8-10) and prior hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm A: * Weeks 1-12: Patients are observed without treatment. Patients with a prostate-specific antigen (PSA) rise of \> 50% above baseline or nadir (whichever is lowest) and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, may be started on bicalutamide before the end of week 12 at the discretion of the treating physician. * Weeks 13-44: Patients with a rise PSA ≥ 50% above baseline or nadir, and a PSA rise of at least 5 ng/mL confirmed by a repeat PSA at least 2 weeks later, are removed from study. Patients receive oral bicalutamide once daily. Patients achieving a PSA decline ≥ 50% in the absence of toxicity may continue to receive bicalutamide up to 72 weeks. * Arm B: * Weeks 1-12: Patients receive oral enzastaurin hydrochloride twice daily. Patients with a PSA rise of \> 50% above baseline or nadir, and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, may be started on bicalutamide before the end of week 12 at the discretion of the treating physician. * Weeks 13-44: Patients with a PSA rise of ≥ 50% above baseline or nadir, and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, are removed from study. Patients receive oral enzastaurin twice daily and oral bicalutamide once daily. Patients achieving a PSA decline ≥ 50% in the absence of toxicity may continue on this combination therapy up to 72 weeks. After completion of study treatment, patients are followed every 3 months for 5 years, and then every 6 months for up to 10 years. | ArmGroups: [{'label': 'Arm A', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients are observed without treatment in weeks 1-12. Patients with a prostate-specific antigen (PSA) rise of \\> 50% above baseline or nadir (whichever is lowest) and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, may be started on bicalutamide before the end of week 12 at the discretion of the treating physician. In weeks 13-44, patients with a rise PSA ≥ 50% above baseline or nadir, and a PSA rise of at least 5 ng/mL confirmed by a repeat PSA at least 2 weeks later, are removed from study. Patients receive oral bicalutamide once daily. Patients achieving a PSA decline ≥ 50% in the absence of toxicity may continue to receive bicalutamide up to 72 weeks.', 'interventionNames': ['Drug: bicalutamide']}, {'label': 'Arm B', 'type': 'ACTIVE_COMPARATOR', 'description': 'In weeks 1-12, patients receive oral enzastaurin hydrochloride twice daily. Patients with a PSA rise of \\> 50% above baseline or nadir, and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, may be started on bicalutamide before the end of week 12 at the discretion of the treating physician. In weeks 13-44, patients with a PSA rise of ≥ 50% above baseline or nadir, and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, are removed from study. Patients receive oral enzastaurin twice daily and oral bicalutamide once daily. Patients achieving a PSA decline ≥ 50% in the absence of toxicity may continue on this combination therapy up to 72 weeks.', 'interventionNames': ['Drug: bicalutamide', 'Drug: enzastaurin hydrochloride']}] | Interventions:[{'type': 'DRUG', 'name': 'bicalutamide', 'description': 'Given orally', 'armGroupLabels': ['Arm A', 'Arm B']}, {'type': 'DRUG', 'name': 'enzastaurin hydrochloride', 'description': 'Given orally', 'armGroupLabels': ['Arm B']}] | PrimaryOutcomes: [{'measure': 'Comparison of proportion of patients with undetectable prostate-specific antigen PSA level (< 0.2 ng/mL) at 44 weeks'}] | SecondaryOutcomes: [{'measure': 'Comparison of proportion of patients achieving ≥ 85% PSA decline at 44 weeks'}, {'measure': 'PSA response'}, {'measure': 'Time to PSA progression'}, {'measure': 'Time to PSA nadir'}, {'measure': 'Duration of PSA response'}, {'measure': 'PSA slope at baseline, during, and after treatment'}, {'measure': 'Effect of Gleason score and prior hormonal therapy on PSA response to treatment'}]
Title: Reliability, Reproducibility, and Efficiency of Functional Compressive Assessment in the Treatment of Secondary Lymphedema to the Treatment of Breast Cancer | Condition: Breast Cancer | Keywords: Functional Compressive Bandage, Lymphedema, Physiotherapy | Summary: | Description: Functional Compressive Bandage (ECF) is a widely used therapeutic resource in the control of lymphedema resulting from the treatment of breast cancer, however, the effects inherent to the technique depend on the quality of the application. The aim of the study is to evaluate the reliability, reproducibility, and efficiency of treatment with different techniques in two studies. To this end, 50 volunteers will be evaluated, aged between 40 and 70 years, submitted to breast cancer treatment. The analyzes will be performed in two subprojects, conducted with randomized cross over design and seven days wash out period, so far 19 volunteers were collected. The first step aims to evaluate the reliability and reproducibility of the technique. The analysis of the pressure exerted by the four-layer bandage, applied by two evaluators previously trained and familiar with the ECF technique will perform the evaluations on the same volunteers in two moments, with an interval of one week between them. The intraclass correlation coefficient (ICC2,1) will be used to determine intra- and inter-examiner reliability, with its respective 95% confidence interval, standard measurement error and minimum detectable change. The second stage aims to verify the efficiency of different ECF techniques in the functionality and circulation of the upper limb affected by lymphedema. This step is being performed by a single evaluator, and the ECF efficiency tested by the random application of two different techniques (spiral and eight), with a seven-day interval, and pressure assessment in mmHg. Upper limb functionality analysis is being performed using the Jebsen Taylor test performed before and with ECF on both limbs. The evaluation of the influence of the bandage in the circulation evaluated by Doppler ultrasound, before and after the test application. Member dominance assessed using the Edinburgh inventory. Partial data was verified by descriptive analysis with mean and standard deviation. Data processing was performed using SPSS® software, version 13.0 (Chicago, IL, USA). A significance level of 5% was considered. The information obtained in the study aims to show the partial results of the preliminary and descriptive evaluation of the physical therapy intervention in women affected by lymphedema resulting from breast cancer treatment. | ArmGroups: [{'label': 'ECF ESPIRAL', 'type': 'EXPERIMENTAL', 'description': "The volunteer is submitted to four-layer spiral functional compressive bandage, then performs Taylor's Jebsen manual function test with comprehensive functional bandage (ECF).", 'interventionNames': ['Other: functional compressive bandage']}, {'label': 'ECF OITO', 'type': 'EXPERIMENTAL', 'description': 'The volunteer is submitted to functional compressive bandage in eight with four layers, then performs the Taylor Jebsen manual function test with the comprehensive functional bandage (ECF).', 'interventionNames': ['Other: functional compressive bandage']}] | Interventions:[{'type': 'OTHER', 'name': 'functional compressive bandage', 'description': 'The functional compressive bandage is being performed with the volunteer sitting with the upper limb homolateral to the surgery supported by a support. After hydration of the limb, a cotton mesh is being used to prevent friction of the 1 cm density foam band being wrapped around the limb. No therapeutic procedure is being performed prior to functional compressive bandage.\n\nThe bandage of the limb is being performed with 5 cm, 10 cm, 15 cm elastic cotton bandages from the fingers to the axillary region in four layers.', 'armGroupLabels': ['ECF ESPIRAL', 'ECF OITO']}] | PrimaryOutcomes: [{'measure': 'Blood Pressure', 'description': 'mmHg', 'timeFrame': '2 minutes'}] | SecondaryOutcomes: [{'measure': 'Blood flow', 'description': 'mL/s', 'timeFrame': '10 minutes'}, {'measure': 'Jebsen Taylor test', 'description': 'time', 'timeFrame': '10 minutes'}]
Title: N/A | Condition: Breast Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Breast Tumor', 'description': 'Breast Tumor Blocks', 'interventionNames': ['Other: Breast Tumor Blocks']}] | Interventions:[{'type': 'OTHER', 'name': 'Breast Tumor Blocks', 'armGroupLabels': ['Breast Tumor']}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A
Title: Developing Risk Prediction Model of Mild Cognitive Impairment in Patients With Colorectal Cancer From Active Treatment to Survivor and Testing the Effect of Dual Task Walking on Improving Cognitive Function | Condition: Colorectal Cancer | Keywords: colorectal cancer, cognitive impairment, chemotherapy, dual-task walking | Summary: | Description: Developing risk prediction model of mild cognitive impairment in patients with colorectal cancer from active treatment to survivor by exploring the effect of surgery and chemotherapy on CICI, and to identify high risk population; and testing the effect of dual-task walking on improving cognitive function (memory, executive function and attention) in CRC patients. | ArmGroups: [{'label': 'Experimental group', 'type': 'EXPERIMENTAL', 'description': 'Participants in the experimental group will receive 3 times interventions during 10th to 12th course of chemotherapy and 12 weekly phone-call to assess effect and barriers of dual-task walking.', 'interventionNames': ['Behavioral: dual-task walking']}, {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Participants in control group will receive usual care.'}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'dual-task walking', 'description': 'Participants will receive 3 times interventions during 10th to 12th course of chemotherapy and 12 weekly phone-call to assess effect and barriers of dual-task walking.', 'armGroupLabels': ['Experimental group']}] | PrimaryOutcomes: [{'measure': 'Self-report Questionnaire', 'description': 'The questionnaire includes 37 items to assess perceived cognitive function', 'timeFrame': 'Change from baseline cognitive function at 12 months'}, {'measure': 'Neuropsychological battery test', 'description': 'Three neuropsychological battery tests will be used to assess cognitive function of executive function.', 'timeFrame': 'Change from baseline cognitive function at 12 months'}, {'measure': 'Neuropsychological battery test', 'description': 'One neuropsychological battery test will be used to assess cognitive function of attention', 'timeFrame': 'Change from baseline cognitive function at 12 months'}, {'measure': 'Neuropsychological battery test', 'description': 'Five neuropsychological battery tests will be used to assess cognitive function of memory', 'timeFrame': 'Change from baseline cognitive function at 12 months'}] | SecondaryOutcomes: [{'measure': 'Self-report Questionnaire', 'description': 'The questionnaire includes 24 items to assess symptom severity', 'timeFrame': 'Change from baseline symptom at 12 months'}]
Title: Retrospective Multicenter Observational Study in NSCLC Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutation Treated First Line by Tyrosine Kinase Inhibitor (TKI) | Condition: NSCLC Non Small Cells Lung Cancer | Keywords: Retrospective, EGFR, mutation, TKI, NSCLC | Summary: | Description: Background : • Lung cancer represents the leading cause of death by cancer in France. Significant advances have been made in recent years on knowledge of oncogenesis of NSCLC in particularly the discovery of specific oncogenic drivers playing major role in oncogenic addiction responsible for the occurrence of NSCLC. Activating mutations of the gene encoding the receptor tyrosine kinase EGFR appeared in a subgroup of patients with NSCLC. In 2010, the search for EGFR mutations in patients with lung cancer was performed in 16,834 patients and the mutation rate was 10.5%. The use of specific inhibitors of EGFR tyrosine kinase in patients with activating mutations of EGFR have shown a significant clinical benefit with a response rate more than 70 % ,with PFS ranging from 9 to 13,1 months and median overall survival from 20 to 30 months. Despite these very good results, all patients develop a resistance to EGFR TKI. This progression is usually defined according to RECIST criteria. These RECIST criteria were established primarily on studies conducted in patients treated with conventional chemotherapy with few or no targeted therapies. In addition, the mode of action of TKI (blocking signalling pathways involved in cell proliferation, angiogenesis, apoptosis, metastasis ..) is very different from the mode of cytotoxic action (action during cell division). Thus, the use of RECIST does not seem to be the most appropriate way to evaluate the response in patients treated by TKI. Despite this, the RECIST criteria have been used to demonstrate superiority of EGFR TKI compared to chemotherapy in patients with EGFR activating mutations in first line setting. In 2010, Pr Jackman proposed a clinical definition of acquired resistance to EGFR TKI : 1. Treatment with a single agent EGFR TKI, 2. Presence of EGFR activating mutation, clinical benefit from treatment with an EGFR TKI 3. Systemic progression of disease according to RECIST or WHO criteria while on continuous treatment with EGFR TKI within the last 30 days TKI 4. No intervening systemic therapy between cessation of EGFR TKI and initiation of new therapy. Tony Mok , in the accompanying editorial, made some criticism to this definition. He argued that it was not uncommon to find new small slow growing tumor nodules after the dramatic initial response to EGFR TKIs. He stated that in this situation, EGFR TKIs could be continued with benefit for the patients. Since then, others clinical situations have been described, such as the emergence of one or even more new metastasis located in one single organ (like the brain or bones), which can be controlled by a loco-regional treatment. The authors found that the continuation of EGFR TKIs in these cases allowed control of the disease for a considerable length of time. More recently, it has been suggested that even loco-regional treatment was not mandatory for EGFR TKIs continuation. Pr Nishino studied retrospectively 56 patients with EGFR activating mutations and acquired resistance. 88% of patients continued EGFR TKI treatment for at least 2 months beyond progressive disease defined according to RECIST criteria. The median time from RECIST progressive disease to termination of TKI for these patients was 10.1 months (range 2.2 to 64.2 months) and the median overall survival was 31.8 months, which is a rather good result. Pr Oxnard, in a similar study, found that in 45% of 42 patients with acquired resistance to EGFR TKI, alternate systemic therapy could be delayed for three months or more. These 19 patients had more frequently the exon 19 deletion and were free of cancer related symptoms at RECIST progressive disease. Another recently published retrospective Japanese study suggested that continuous use of EGFR-TKI beyond progressive disease may prolong overall survival compared with switching to cytotoxic chemotherapy in patients with EGFR activating mutations. A prospective ASIAN phase II study (ASPIRATION) has been recently completed. It compared the continuous use of erlotinib versus stopping erlotinib at progression according to RECIST criteria. Patients could continue erlotinib if progression was slow (\> 6 months stability), asymptomatic minimal increase and/or new cerebral metastasis controlled locally. The patients switch to another systemic treatment if they had rapid progressive disease, extra brain symptomatic metastasis, deterioration of Performance Status (PS) or life threatening complications. The results of this study should be available in December 2014. Purpose : The purpose of our retrospective study is to describe which circumstances EGFR TKI is continued despite progression according to the usual RECIST criteria in patients with EGFR activating mutations and acquired resistance to EGFR TKI. This study concerns patients who have began a TKI treatment in first line from 1st JANUARY 2010 to 1st JUNE 2012.We'll collect their social and demographic data (age, sex), first PFS (from start of EGFR TKI: PFS 1) and second (from first progression according to RECIST 1.1 to second progression : PFS2) , OS (from diagnosis OS 1 and from first progression OS2), mutational status, and we will analyze more closely the mode of progression (site), the therapeutic approach at disease progression. We will define two subgroups: those for whom EGFR TKI was continued at least three months despite progression defined according to RECIST criteria, and those for whom a second-line treatment (chemotherapy without EGFR TKI) was chosen at disease progression. It will be individualized the subgroup of patients in whom it was continued TKI after progression. In this subgroup, it will be searched for a correlation between delaying systemic therapy (second line) by pursuing a EGFR TKI at least 3 months and various parameters: * Type of EGFR mutation * Symptoms at disease progression * Clinical characteristic * Emergence of new metastases vs increasing size of known targets * Speed of decay and tumour progression (% per month) * Delivery of loco-regional treatment when relapse occurs in a single site * PFS (PFS1 and PFS2) and OS (OS1) from the first progression in this group will be compared to the general population (population for which there was TKI stop to the progression) with EGFR activating mutations. | ArmGroups: [{'label': 'Patients NSCLC EGFR mutated', 'description': 'This is an observational study, there is no intervention.'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Proportion of patients continuing TKI at 1st progression and proportion of patients discontinuing EGFR TKI at 1st progression. Analysis of the therapeutic management in the 2 groups. This outcome consists in multiple measures.', 'description': '• Primary outcome: the therapeutic management of secondary resistance to EGFR TKI (erlotinib or gefitinib) in patients with advanced NSCLC with EGFR activating mutation. Comparison of demographic, clinical, biological features and outcome of patients continuing EGFR TKI at progression versus interrupting TKI at progression. Composite measures will be performed : demographic and clinical data, Progression Free Survival (PFS), Overall Survival (OS), mutational status, mode of progression, therapeutic approach at progressive disease in patients with EGFR mutation treated in first line by EGFR TKI (all population and subgroups : patients receiving EGFR-TKI at progressive disease - Group 1 -, patients discontinuing EGFR TKI at progressive disease - Group 2- ).', 'timeFrame': 'Patients are followed up to 48 Months maximum'}] | SecondaryOutcomes: [{'measure': 'Comparison of clinical data and outcome of patients', 'description': 'A comparison of clinical data and outcome of patients receiving EGFR-TKI beyond progressive disease (group 1) versus discontinuing EGFR-TKI at progressive disease (group 2) will be made.', 'timeFrame': 'Patients are followed up to 48 Months maximum'}, {'measure': 'Median Progression Free Survival (PFS)', 'description': '• Median Progression Free Survival (PFS) (months) in group 1 and 2 - from start of EGFR TKI to first progression : PFS 1- and - from first progression to second progression : PFS2 -.', 'timeFrame': 'Patients are followed up to 48 Months maximum'}, {'measure': 'Univariate and multivariate analysis of Median over survival (OS)', 'description': '• Univariate an multivariate analysis of OS between the 2 groups will be adjusted using the Cox model. Variables as : age, gender, PS, histology, brain metastasis, EGFR mutations (deletions in exon 19, L858R mutations), TKI continued or TKI stopped at progression, metastasis number and site, will be considered for adjustment.', 'timeFrame': 'Patients are followed up to 48 Months maximum'}, {'measure': 'Univariate and multivariate analysis of OS', 'description': '• Univariate and multivariate analysis of OS between the 2 groups will be adjusted using the Cox model. Following variables will be considered for adjustment: age, gender, PS, histology, brain metastases, EGFR mutations (deletions in exon 19, L858R mutations), TKI continued to progression or TKI stopped at progression, metastasis number and site', 'timeFrame': 'Patients are followed up to 48 Months maximum'}]
Title: A Single-arm, Open-label， Phase Ⅱ Clinical Trial of Eutideron, Etoposide Combined With Bevacizumab for Breast Cancer Patients With Brain Metastases | Condition: Mammary Neoplasms, Human | Keywords: | Summary: | Description: The natural survival time of breast cancer patients with brain metastases is short and the prognosis is poor. Although the treatment is progressing, but it is still limited. The current domestic guidelines still recommend local therapy as a priority treatment strategy. At the same time, about 80% of patients with brain metastasis will progress to extracranial metastasis, so superior systemic treatment is particularly important, but very lacking.Therefore, new systematic therapeutic drugs are urgently needed .Eutiderone is a new generation of epirubicin anti-tumor drug with good efficacy and safety. In pre-clinical studies, it has been shown that the drug concentration in most tissues is higher than that in plasma, and the concentration of eutiderone in brain tissue is higher, indicating that the drug is easy to cross the blood-brain barrier. | ArmGroups: [{'label': 'eutidrone+ etoposide+ bevacizumab', 'type': 'EXPERIMENTAL', 'description': 'Eligible patients received a regimen of eutidrone(30mg/m2/d,iv,d1-5,21d/cycle), etoposide(30mg/m2/d,iv,d1-3,21d/cycle), and bevacizumab (10mg/kg,d1,21d/cycle).At least 4 to 6 cycles were administered, and if patients had a response or stable disease, bevacizumab was used as maintenance therapy until disease progression or intolerable toxicity.', 'interventionNames': ['Drug: eutidrone etoposide bevacizumab']}] | Interventions:[{'type': 'DRUG', 'name': 'eutidrone etoposide bevacizumab', 'description': 'Eligible patients received a regimen of eutidrone(30mg/m2/d,iv,d1-5,21d/cycle), etoposide(30mg/m2/d,iv,d1-3,21d/cycle), and bevacizumab (10mg/kg,d1,21d/cycle).At least 4 to 6 cycles were administered, and if patients had a response or stable disease, bevacizumab was used as maintenance therapy until disease progression or intolerable toxicity.MRI of the brain with contrast enhancement was performed at baseline and every 6 weeks after enrollment; thereafter, patients with stable disease or a response could be assessed at a reduced frequency to every 9 weeks; central nervous system and noncentral nervous system lesions were assessed according to RANO-BM criteria and RECIST v1.1 criteria until disease progression, respectively.', 'armGroupLabels': ['eutidrone+ etoposide+ bevacizumab']}] | PrimaryOutcomes: [{'measure': 'CNS Objective response rate (CNS-ORR)', 'description': 'The proportion of patients with complete response (CR) and partial response (PR) evaluated as the best response observed from enrollment to progression of all CNS target lesions assessed according to RANO-BM criteria among the total number of patients who could be evaluated.', 'timeFrame': '12 months'}] | SecondaryOutcomes: [{'measure': 'CNS Clinical benefit rate(CNS-CBR)', 'description': 'Percentage of patients who achieved complete response (CR), partial response (PR), or stable disease (SD) in all CNS target lesions assessed by RANO-BM criteria within 12 weeks.', 'timeFrame': '3 months'}, {'measure': 'CNS Progression-free survival (CNS-PFS)', 'description': 'Time from enrollment to the first radiographic documented disease progression (PD) of all CNS target lesions (RANO-BM criteria) or death from any cause without progression was recorded.', 'timeFrame': '36 months'}, {'measure': 'Objective response rate (ORR)', 'description': 'Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions', 'timeFrame': '12 months'}, {'measure': 'Progression-free survival（PFS）', 'description': 'Time from enrollment to the first radiographically confirmed disease progression (PD) (RECIST 1.1 criteria) or death from any cause without documented progression', 'timeFrame': '36 months'}, {'measure': 'Overall survival (OS)', 'description': 'Time from the enrollment to death of any cause', 'timeFrame': '36 months'}]
Title: Preoperative Rehabilitation With Stoma Appliance in Colorectal Cancer Patients, A Randomized Controlled Trial | Condition: Rehabilitation | Keywords: | Summary: | Description: Colorectal cancer is third cancer worldwide after breast and lung cancer accounting for 10% of all cancer cases and 9.4% of cancer deaths. Over 2.2 million new colorectal cancer cases and 1.8 million deaths have been estimated to occur in 2020. In Egypt, it is the seventh cancer, accounting for 3.9% of all cancers, with about 5,000 new cases annually. Colorectal resections are often associated with temporary or permanent stoma formations. In the United Kingdom it is estimated that more than 20,000 new stomas are created each year, 11,800 of them were colostomies. About one-half of the stoma was permanent. The formation of a stoma is associated with psychologic morbidity, which can be reduced with preoperative and postoperative patient education and psychologic support. Living with a stoma is a challenging situation for various reasons including uncontrolled gas passage through it, diarrhea, odor, and leakage around the stoma or appliance. It would take several months for the patients to adjust to this difficult time. At that point, the patient's Quality of life becomes essential for the remaining time. Ostomy formation is one of the therapeutic procedures performed to manage bowel dysfunction due to various reasons; however, it affects quality of life of patients. World health organization defines QOL as an individual's perspective of his/her health status concerning a few aspects- physical, psychological, economic, social, and environmental. A stoma influences the physical, mental, emotional, and social life of the patient significantly. A good quality of life is essential to achieve a comprehensive approach to treating patients. A study done in China to assess stoma related quality of life using a stoma self-care agency scale and health hope index showed that patients had difficulties in work and social institutions. Additional concerns pointed out were sexuality, body image and the stoma itself. A long-term effect on the quality of life of members of the United Ostomy Association of America after 5 years of ostomy surgery was assessed using a questionnaire. Their report has shown that patients feel better as they live longer with the stoma. Research done on Iranian by ostomy society has shown that factors such as the type of ostomy, the underlying disease that had led to the stoma formation, depression after ostomy, dissatisfaction with sexual activities, a problem with the location of ostomy and change in clothing style affected the Quality of Life. Ostomies can lead to intensified distress and suffering in patients because of skin irritation (76%), pouch leakage (62%), offensive odor (59%), reduction in pleasurable activities (54%), and depression/anxiety (53%). In such circumstances, it is worthwhile to assess the quality of life in the evaluation of the outcomes of various therapeutic procedures along with their final impact on patients' lives. Quality of care and training provided to patients can be associated with their subsequent quality of life. The main aim of this study is to assess the effects of preoperative education on stoma self-care, quality of life, Anxiety, and depression levels in colorectal cancer patients with a stoma. | ArmGroups: [{'label': 'standard postoperative education.', 'type': 'ACTIVE_COMPARATOR', 'description': 'These patients will receive stoma care and stoma education beginning on postoperative day1.', 'interventionNames': ['Behavioral: Rehabilitation with stoma appliance']}, {'label': 'preoperative rehabilitation group', 'type': 'EXPERIMENTAL', 'description': 'The rehabilitation group will receive preoperative stoma education in addition', 'interventionNames': ['Behavioral: Rehabilitation with stoma appliance']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Rehabilitation with stoma appliance', 'description': 'The rehabilitation group will receive preoperative stoma education in addition, a water-filled ostomy appliance (50-100 ml) will be attached 48 hours before surgery. These pouches will not be removed until surgery, and the EST nurse will teach the patients preoperatively how to manage the ostomy appliance with similar standards as described in the usual postoperative stoma care.', 'armGroupLabels': ['preoperative rehabilitation group', 'standard postoperative education.']}] | PrimaryOutcomes: [{'measure': 'duration of hospital stay', 'description': 'Compare duration from surgery until independent stoma self-care between preoperative rehabilitation using a stoma appliance group and traditional care group.', 'timeFrame': '1 year'}] | SecondaryOutcomes: [{'measure': 'Assess anxiety and depression', 'description': 'Assess anxiety and depression according to HADS (Hospital Anxiety and Depression Scale).\n\n0-7 normal 8-10 border line abnormal 11-21 abnormal', 'timeFrame': '9 monthes'}, {'measure': 'assess the effects of preoperative education using stoma appliance on quality of life in colorectal cancer patients with a stoma', 'description': 'Assess the quality of life of those patients including physical, social/family, emotional, functional wellbeing, using FACT-C version 4 (Functional Assessment of Cancer Therapy-Colorectal) questionnaire.\n\nrecall period past 7 days response scale 5point Likert-type scale total a FACT-C score (functional assessment of cancer therapy -colorectal) range 0-136 the higher the score the better the quality of life', 'timeFrame': '11 months'}]
Title: Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study | Condition: Inflammatory Bowel Disease, Colorectal Cancer | Keywords: IBD, colitis, dysplasia, colorectal cancer | Summary: | Description: N/A | ArmGroups: [{'label': 'Patients with inflammatory bowel disease', 'description': "patients with a diagnosis of ulcerative colitis, Crohn's colitis or indeterminate colitis between 18 and 70 years of age. Patients should have an indication for surveillance according to the current guidelines, which means a disease duration of at least 8 years and involvement of at least 30% of the colon."}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'low- or high grade dysplasia or colorectal cancer during follow-up', 'timeFrame': '5 years'}] | SecondaryOutcomes: N/A
Title: A Phase II Double Blind Randomized Trial Comparing Standard Dosing Based on Body Surface Area Versus Dosing Based on Personalized Lean Body Mass in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Receiving First Line Cisplatin Based Chemotherapy | Condition: Lung Cancer | Keywords: cisplatin based chemotherapy, non-small cell lung cancer, lean body mass, sarcopenia | Summary: | Description: Retrospective findings of NSCLC patients treated with a cisplatin based chemotherapy regimen show that although all were given cisplatin at the standard rate of 75 mg/m2 according to lean body mass, when this was expressed in relation to individual lean body mass, there was a high degree of variation. Incidence of dose limiting toxicity was 41% in patients whose dose was within + 25% of the median value. However, sarcopenic patients received on average a 35% higher dose and 80% of these patients experienced severe toxicity requiring dose reduction or termination of therapy, a clinically unacceptable level. The relatively muscular subset of patients with higher lean body mass had a reduced level of severe toxicity compared to those at the median dose. These findings have led to the design of a study with the goal of reducing high levels of toxicity in sarcopenic patients. If the expected level of dose limiting toxicity in sarcopenic patients is 80% based on the standard method of dosing, this could be expected to be reduced to the median value of 41% dose limiting toxicity by the administration of cisplatin scaled to individual lean body mass. Hypothesis: Levels of severe toxicity in sarcopenic patients may be reduced to clinically acceptable levels by cisplatin dosing scaled to 3.1 mg/kg lean body mass compared with standard dosing of 75 mg/m2 based on body surface area. | ArmGroups: [{'label': 'Body Surface Area Dosing', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard dosing arm based on body surface area', 'interventionNames': ['Other: Standard dosing method arm: Cisplatin (chemotherapy) dosing based on body surface area']}, {'label': 'Lean Body Mass Dosing', 'type': 'EXPERIMENTAL', 'description': 'Experimental dosing arm based on individual lean body mass', 'interventionNames': ['Other: Experimental dosing method arm: Cisplatin (chemotherapy) dosing based on individual lean body mass']}] | Interventions:[{'type': 'OTHER', 'name': 'Standard dosing method arm: Cisplatin (chemotherapy) dosing based on body surface area', 'description': 'Cisplatin dosing calculated at the rate of 75 mg/m2', 'armGroupLabels': ['Body Surface Area Dosing']}, {'type': 'OTHER', 'name': 'Experimental dosing method arm: Cisplatin (chemotherapy) dosing based on individual lean body mass', 'description': 'Cisplatin dosing calculated at the rate of 3.10 mg/kg lean body mass', 'armGroupLabels': ['Lean Body Mass Dosing']}] | PrimaryOutcomes: [{'measure': 'Dose limiting toxicity rates', 'timeFrame': 'Assessed weekly until patients come off study (an expected average of 9 weeks)'}, {'measure': 'Number of Cycles completed', 'timeFrame': 'Assessed weekly until patients come off study (an expected average of 9 weeks)'}] | SecondaryOutcomes: [{'measure': 'Survival', 'description': 'If a patient has deceased, the date of death is recorded. If a patient is alive, the status is checked again in another 60 days. This is carried out through health records and not through direct contact with the patient.', 'timeFrame': 'Assessed every 60 days from the date of removal from the trial (an expected average of 9 months)'}]
Title: Incidence and Risk Factors of Early Onset Colorectal Cancer | Condition: Colorectal Neoplasms | Keywords: | Summary: | Description: The investigators retrospectively assessed the incidence of all neoplastic lesions, advanced neoplasias and colorectal cancer in population under 50 years of age compared to population 50 years and older. The investigators collected the data from all colonoscopic examinations performed in non-university hospital Frydek-Mistek from January 2012 to the end of June 2021. | ArmGroups: [{'label': '50 years and over', 'description': 'patients who underwent colonoscopic examination aged 50 years and over', 'interventionNames': ['Other: colonoscopy']}, {'label': 'under 50 years', 'description': 'patients who underwent colonoscopic examination aged under 50 years', 'interventionNames': ['Other: colonoscopy']}] | Interventions:[{'type': 'OTHER', 'name': 'colonoscopy', 'armGroupLabels': ['50 years and over', 'under 50 years']}] | PrimaryOutcomes: [{'measure': 'incidence of early onset colorectal neoplasias, risk factors', 'description': 'the real-life incidence of early onset colorectal cancer, advanced neoplasias (colorectal cancer and/or advanced adenoma) and all neoplastic lesions in total in a single non-university endoscopic center, the risk of sex and family history of colorectal cancer', 'timeFrame': '10 years'}] | SecondaryOutcomes: N/A
Title: Non-functioning Pancreatic Neuroendocrine Tumors (NF-pNETs) in Multiple Endocrine Neoplasia Type 1 (MEN1) Treated With Somatostatin Analogs (SA) Versus NO Treatment - a Prospective, Randomized, Controlled Multicenter Study | Condition: Pancreatic Neuroendocrine Tumors in MEN1 | Keywords: | Summary: | Description: 1. Introduction 1.1 Background Due to the genetic background of the disease, every single neuroendocrine cell of the pancreas is a potential progenitor of neuroendocrine tumors (NETs). More than 90% of patients with multiple endocrine neoplasia type 1 (MEN1) develop multiple pancreatic neuroendocrine tumors (pNETs) "viewable" by transgastric endosonography and/or cross sectional and/or functional imaging. These tumors are the most common cause for premature death in MEN1 (1, 2). While functioning pNETs are to be treated to reduce or cure hormonal excess, the strategies of addressing non-functioning (NF) pNETs are under discussion. Treatment ranges from "watchful waiting" to subtotal or total pancreatectomy (3-6). The latter may prove to be an "overtreatment" resulting in diabetic metabolic status and subsequently in general long-term complications. Somatostatin analogs (SAs) have shown promising results with regard to progression-free survival in patients with metastatic NETs of the midgut (9-11). As shown recently in a retrospective study of 40 patients with early-stage MEN1 duodeno-pancreatic NETs, treatment with SAs was safe and effective, resulting in long-time suppression of tumor and hormonal activity and 10% objective response. The authors suggest to start therapy with SAs early on in patients with MEN1-related NETs (12). Apart from this clinical study, there is one case report on SAs for MEN-1-related insulinoma (13). MEN1 is an orphan disease (ORPHA652). 2. Rationale and objectives In this prospective, randomized observation study, the benefits of subcutaneous application of somatostatin analogs (SAs) every 28 days (group 1) will be compared to no treatment (group 2). It has not been proven if the beneficial effects of SAs shown in advanced disease are also applicable to patients with early stage (≤20mm) pancreatic neuroendocrine tumors in MEN1. "Watch and wait" without medical treatment is the standard approach for MEN1 patients in this early stage of pancreatic disease. We hypothesize that SAs can decelerate tumor progression (according to our outcome parameters). 3. Study design 3.1 Design Prospective, randomized, controlled, observation trial 3.2 Study population Patients with proven MEN 1 (see eligibility criteria) will be recruited after discussing her/his individual clinical situation in the interdisciplinary tumor board. The listed examinations and tests will be carried out in each patient before the first day of study participation: * Medical history and physical examination * Height and weight * Biochemical parameters (chromogranin A \[CgA\] level) 3.3 Description of study days The patients will be evaluated in six-monthly intervals biochemically and radiologically (according to the protocol below). 3.4 Withdrawal and replacement of subjects Patients will be withdrawn under the following circumstances: * At their own request * If the investigators feel it would not be in the best interests of the patient to continue. In all cases, the reasons why study subjects were withdrawn will be recorded in detail in the case report forms (CRFs) and in the subjects' medical records. Should the study be discontinued prematurely, all study materials (completed, partially completed and empty CRFs) will be retained. 4 Methods of evaluation Functional imaging (DOTA-conjugated peptide PET-CT or MRI) will be performed and venous blood samples will be drawn as baseline evaluation for general laboratory tests and Chromogranin A (CgA). 4.1 Imaging modalities DOTA-conjugated peptide PET-CT or MRI will be acquired on baseline and after 12, 24, 36, 48 and 60 months Radiological interim assessments will be performed by MRI at 6, 18, 30, 42 and 54 months. 4.2 Laboratory parameters A venous blood sample will be drawn at each assessment (baseline, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months). CgA will be determined in each sample, general laboratory tests will be made yearly (starting from baseline). 4.3 Adverse events (AE) An AE is any event during a clinical study, including intercurrent illness or accident, which impairs the well-being of the patient; it may also take the form of an abnormal laboratory value. The term AE does not imply a causal relationship with the study therapy. All subjects experiencing AEs - whether considered associated with the study therapy or not - will be monitored until symptoms subside and any abnormal laboratory values have returned to baseline, or until there is a satisfactory explanation for the changes observed, or until death, in which case a full pathologist's report will be supplied, if possible. All findings must be reported on an "AE" page in the "case report form (CRF)". All AEs are divided into the categories "serious" and "non-serious". This determines the procedure that must be used to report/document the AE (see below). 4.3.1 Definition of serious and non-serious adverse events A serious AE is: * Any event that is fatal or life-threatening * Any event that is permanently disabling * Any event that requires hospitalization AEs that do not fall into these categories are defined as non-serious. 4.3.2 Reporting /documentation of adverse events AEs will be collected by spontaneous reporting. 4.3.3 Assessment of severity Regardless of the classification of an AE as serious or non-serious (see above), its severity must be assessed as mild, moderate or severe, according to medical criteria alone: Mild = does not interfere with routine activities, considered as acceptable Moderate = interferes with routine activities Severe = impossible to perform routine activities, considered as unacceptable Further categories: Requires treatment, requires discontinuation of study, or has residual effect. It should be noted that a severe AE need not be serious in nature and that a serious AE need not, by definition, be severe. Regardless of severity, all serious AEs must be reported as above. 4.4 Data handling procedures A CRF will be completed for each patient. Trained personnel will check the entries and any errors or inconsistencies will be clarified immediately. The results of the pre-study screening examination will be documented in the study master file. 4.5 Biometric methods 4.5.1 Biometric methods 1. Descriptive analysis 2. After analysis for data distribution, parametric or non-parametric statistical tests will be applied 4.5.2 Biometric methods - adverse events/safety investigations All AEs will be properly listed and an appropriate method will be used to summarize the data. 5 Ethical and legal aspects The study will be performed in accordance with the guidelines of the Declaration of Helsinki (1964), including current revisions. 5.1 Informed consent of the patient Before being admitted to the clinical investigation, patients must have consented to participate after the nature, scope and possible consequences of the clinical study have been made understandable to them in writing. Patients must give a written consent. Their consent will be confirmed by the signature of one investigator. 5.2 Acknowledgment/approval of the study Before the start of the study, the study protocol will be submitted to the Ethics Committee of the Medical University of Vienna and, if necessary, to the responsible Ethics Committees of the participating centers. 5.3 Confidentiality All subjects' names will be kept secret in the investigators' files. Subjects will be identified throughout documentation and evaluation by the number allotted to them at the beginning of the study. The subjects will be informed that all study findings will be stored and handled in strictest confidence. 6 Documentation and use of study findings 6.1 Documentation of study findings All findings collected during the study will be entered on the CRFs. CRFs will be completed immediately after the final examination. 6.2 Use of study findings The findings of this study will be published by the investigators in a scientific journal and presented at scientific meetings. The manuscript will be circulated to all co-investigators before submission. 7 Protocol amendments If any modifications become necessary or desirable, these will be documented in writing; major changes will require the approval of all investigators and the Ethics Committee. | ArmGroups: [{'label': 'Somatostatin-Analog', 'type': 'EXPERIMENTAL', 'description': 'A long acting somatostatin analog will be applied.', 'interventionNames': ['Drug: Somatostatin-Analog']}, {'label': 'No treatment', 'type': 'NO_INTERVENTION', 'description': 'This arm will be be the observational control according to the endpoints of the study. No intervention will be made.'}] | Interventions:[{'type': 'DRUG', 'name': 'Somatostatin-Analog', 'description': 'A long-acting somatostatin-analog will be applied.', 'armGroupLabels': ['Somatostatin-Analog']}] | PrimaryOutcomes: [{'measure': 'Growth rate of the tumor in mm', 'description': 'The growth rate of the leading lesion (≥20mm in diameter) will be radiologically controlled in six-monthly intervals. Growth rate will be compared between the groups.', 'timeFrame': '5 years'}] | SecondaryOutcomes: [{'measure': 'Documentation of new tumors', 'description': 'In intervals of 6 months radiologic examinations of the pancreas will be made, thereby newly developed tumors can be documented and will be compared between the groups.', 'timeFrame': '5 years'}, {'measure': 'Documentation of lymph node and/or distant metastases', 'description': 'Functional imaging will be made in intervals of 12 months. With this modality newly arisen metastatic lesions can be documented. The development of those lesions will be compared between the groups.', 'timeFrame': '5 years'}]
Title: Pharmacodynamic Trial: Molecular Marker & Imaging Studies as Primary Endpoints to Determine Optimal Biological Dosage of Perifosine, Orally Avail AKT PH Domain Inhibitor Combined w/ Docetaxel in Patients w/Relapsed Epithelial Ovarian Cancer | Condition: Ovarian Cancer | Keywords: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Perifosine, Docetaxel, Taxotere | Summary: | Description: Docetaxel is a chemotherapy drug designed to kill some cancers and is believed to be slightly effective at killing blood vessels in cancers. Perifosine is a new drug that may help docetaxel be more effective in causing cancer cells to die. Perifosine alone may slow cancer cell growth by targeting an abnormal pathway in your ovarian cancer cells. If you are found to be eligible to take part in this study, you will receive your dose of perifosine by mouth every 6 hours on Day 1 of therapy. The actual number of pills in your dose depends upon which dose level you are assigned to. You will then continue receiving perifosine by mouth once a day for 20 more days. Each cycle of treatment is about 28 days. On Day 5 of therapy, of the first cycle only, you will have blood drawn (about 2.5 tablespoons) performed, and 5 hair follicles and ascites collected, if available. If you do not have ascites, you will have a FNA performed on your tumor. On Day 8 of therapy, you will have a DCE-MRI. On Day 10 of therapy, you will have a PET scan. Your treatment schedule for each cycle will usually be the same. There may be a one-day difference in the treatment schedules. After the first cycle is completed, you will begin receiving docetaxel, on Day 2 of therapy of each cycle of treatment, as an injection in a vein over 60 minutes at the M. D. Anderson infusion center. The second cycle of treatment will start on Day 29. Within 72 hours of the start of each cycle, you will have blood (about 1 tablespoon) and urine collected for routine tests . After you receive the drugs, you will have weekly blood tests (about 1 tablespoon) to evaluate your well being. Before the start of each cycle of therapy, you will have a physical exam, and your medical history will be recorded. You will also be called by the study doctor or staff to ask questions about any side effects you may be experiencing during therapy. After the end of every 2 cycles (about every 8 weeks), you will have an x-ray and either a CT scan or an MRI to re-evaluate your cancer. You may be given treatment on this study as long as your disease does not get worse. Your physician will discuss with you the maximum number of treatment cycles you will receive. You will be taken off this study if your disease gets worse or if you experience any intolerable side effects. After your participation in this study has ended, you will come back for a follow-up visit. At this visit, you will have your medical history recorded and a physical exam. You will have blood (about 1 tablespoon) and urine collected for routine tests. You may also have a CT scan or an MRI to re-measure and re-evaluate your cancer. You will have follow-up for as long as needed after you have completed treatment with perifosine plus docetaxel. You will either be contacted by phone or asked to come to the clinic for a routine visit. You will be contacted every 8 weeks. You will have radiographic evaluations, by either a CT or an MRI, done every 12 weeks to evaluate your cancer growth or until you start on another anticancer therapy. This is an investigational study. Perifosine has been authorized by the FDA for use in research only. Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson. | ArmGroups: [{'label': 'Perifosine + Docetaxel', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Perifosine', 'Drug: Docetaxel']}] | Interventions:[{'type': 'DRUG', 'name': 'Perifosine', 'description': 'Loading Dose = 100 mg by mouth (PO) every 6 hours, followed by 50 mg by mouth (PO) daily', 'armGroupLabels': ['Perifosine + Docetaxel']}, {'type': 'DRUG', 'name': 'Docetaxel', 'description': '75 mg/m\\^2 by vein over 1 hour every 4 weeks', 'armGroupLabels': ['Perifosine + Docetaxel'], 'otherNames': ['Taxotere']}] | PrimaryOutcomes: [{'measure': 'Tumor Response', 'timeFrame': 'After the end of every 2 cycles (about every 8 weeks), an x-ray and either a CT scan or an MRI will be obtained to re-evaluate tumor response.'}] | SecondaryOutcomes: N/A
Title: Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Localized Intermediate Risk Prostate Cancer. | Condition: Localized Prostate Cancer | Keywords: | Summary: | Description: This is a single center, single-arm, open-label, 60-month follow-up phase IIb clinical trial. The primary objective of the study is to evaluate the absence of biopsy detectable Gleason grade 4 or 5 prostate cancer tumors anywhere in the prostate gland on 12-month, post-treatment biopsy following TOOKAD® Soluble-VTP. Men with Gleason score 7 (3+4) prostate cancer on one half of the prostate will receive TOOKAD® Soluble VTP under general anesthesia. Treatment will consist in hemiablation procedure designed to destroy the lobe of the prostate gland that contains the Gleason score 7 (3+4) cancer. Afterwards, patients will be followed for 5 years (60 months) with clinical evaluation, questionnaires on QOL, erectile and urinary functions, and PSA testing. In addition, treatment outcomes will be assessed based on prostate biopsy results at 3, 12, 24, 36, 48 and 60 months after the TOOKAD® Soluble treatment. All patients will undergo biopsy at 3 and 12 months. If the Month 3 biopsy is positive for any cancer, patients will be allowed a single re-treatment by TOOKAD® Soluble VTP to one or both lobes. | ArmGroups: [{'label': 'TOOKAD Soluble 4 mg/kg', 'type': 'EXPERIMENTAL', 'description': 'TOOKAD® Soluble VTP treatment consist of the combination of a single, 10-minute IV infusion of TOOKAD® Soluble at the dose of 4 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds.', 'interventionNames': ['Drug: TOOKAD Soluble 4 mg/kg']}] | Interventions:[{'type': 'DRUG', 'name': 'TOOKAD Soluble 4 mg/kg', 'description': 'Vascular targeted photodynamic therapy using TOOKAD Soluble', 'armGroupLabels': ['TOOKAD Soluble 4 mg/kg'], 'otherNames': ['WST11']}] | PrimaryOutcomes: [{'measure': 'Number of Participants With Negative Biopsy for Gleason Grade 4 or 5 Prostate Cancer on 12-month Post-treatment', 'description': 'Binary response to treatment defined as absence of Gleason grade 4 or 5 on biopsy on 12-month post-treatment following TOOKAD® Soluble VTP in men with Gleason score 7 (3+4) prostate cancer', 'timeFrame': '12 months'}] | SecondaryOutcomes: [{'measure': 'Absence of Gleason Grade 4 or 5', 'description': 'Binary response to treatment defined as the absence of any Gleason grade 4 or 5 biopsy on or before months 24, 36, 48 and 60. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of gleason grade 4 or 5, the subject will be considered to have responded;', 'timeFrame': 'months 24, 36, 48 and 60'}, {'measure': 'Absence of Any Prostate Cancer on Biopsy', 'description': 'Binary response to treatment defined as the absence of any prostate cancer on biopsy on or before months 3, 12, 24, 36 and 60. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of any cancer, the subject will be considered to have responded;', 'timeFrame': 'months 3, 12, 24, 36 and 60'}, {'measure': 'Absence of Any Gleason 4 or 5 in the Treated Lobe', 'description': 'Binary response to treatment defined as the absence of any Gleason grade 4 or 5 biopsy on or before months 12, 24, 36, 48 and 60 in the treated lobe. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of gleason grade 4 or 5, the subject will be considered to have responded;', 'timeFrame': 'months 12, 24, 36, 48 and 60'}, {'measure': 'Absence of Any Prostate Cancer on Biopsy in the Treated Lobe', 'description': 'Binary response to treatment defined as the absence of any prostate cancer on biopsy on or before months 3, 12, 24, 36, 48 and 60 in the treated lobe. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of any cancer, the subject will be considered to have responded', 'timeFrame': 'months 3, 12, 24, 36, 48 and 60'}, {'measure': 'Changes in Biopsy Parameters (Gleason Score)', 'description': 'Changes in biopsy parameters (Gleason score) between the baseline biopsy and Month 3, Month12, Month 24, Month 36, Month48 and Month 60 biopsies', 'timeFrame': 'months 3, 12, 24, 36, 48 and 60'}, {'measure': 'Changes in Biopsy Parameters (Number of Positive Score)', 'description': 'Changes in biopsy parameters (number of positive score) between the baseline biopsy and Month 3, Month12, Month 24, Month 36, Month48 and Month 60 biopsies', 'timeFrame': 'months 3, 12, 24, 36, 48 and 60'}, {'measure': 'Changes in Biopsy Parameters (Cancer Core Length)', 'description': 'Changes in biopsy parameters (cancer core length) between the baseline biopsy and Month 3, Month12, Month 24, Month 36, Month48 and Month 60 biopsies', 'timeFrame': 'months 3, 12, 24, 36, 48 and 60'}, {'measure': 'IPSS Questionnaire', 'description': "Changes in patients' reported outcome measures (PROMs) for urinary symptoms using IPSS (changes in IPSS scores from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months after treatment)", 'timeFrame': 'months 1, 3, 6, 12, 24, 36, 48 and 60'}, {'measure': 'IIEF15 Questionnaire', 'description': "Changes in patients' reported outcome measures (PROMs) for erectile function using IIEF 15 (changes in IIEF 15 scores from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months after treatment)", 'timeFrame': 'months 1, 3, 6, 12, 24, 36, 48 and 60'}, {'measure': 'Severe Prostate Cancer-related Events', 'description': 'Severe prostate cancer-related events: cancer extension to T3, metastasis or prostate cancer-related death', 'timeFrame': 'Up to 60 months'}, {'measure': 'Secondary Prostate Cancer Treatment', 'description': 'Use of secondary prostate cancer treatment following VTP will include surgical removal of the prostate gland, radiation treatment to the prostate gland, use of hormone or chemotherapies', 'timeFrame': 'Up to 60 months'}, {'measure': 'Adverse Events', 'description': 'Collection Adverse events', 'timeFrame': 'Up to 60 months'}, {'measure': 'PSA', 'description': 'Serum PSA measurements in ng/mL.', 'timeFrame': 'Months 1, 3, 6, 12, 24, 36, 48, 60'}]
Title: Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza) | Condition: Breast Neoplasms, Lymphoma | Keywords: | Summary: | Description: Prospective feasibility and validation study of a novel contrast microhalography (CEM) device for diagnosis of malignancy in Botswana. Consenting patients identified by their providers as requiring a fine needle aspirate (FNA) or percutaneous biopsy for assessment for possible lymphoma or breast cancer will undergo standard diagnostic procedure. Concurrently these patients will have additional FNA fluid tested using the portable novel nanosensor-based device (CEM). Diagnosis made from standard anatomic pathology, flow cytometry, and/or cytology will be compared with the diagnosis made using the CEM platform. Assessment of the feasibility and acceptability of the CEM platform will be performed. Assessment of training requirements for CEM platform will be completed. | ArmGroups: [{'label': 'Standard diagnosis and CEM platform', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive standard diagnostic approach and assessment by CEM platform', 'interventionNames': ['Diagnostic Test: Contrast Microhalography (CEM)']}] | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'Contrast Microhalography (CEM)', 'description': 'Fine needle aspirates evaluated by CEM device', 'armGroupLabels': ['Standard diagnosis and CEM platform']}] | PrimaryOutcomes: [{'measure': 'Accuracy for diagnosis of non-Hodgkin lymphoma', 'description': 'Accuracy (proportion of true positive and true negative out of total number assessed) of CEM in comparison with standard diagnostic approach.', 'timeFrame': 'Day 1, at time of diagnosis'}, {'measure': 'Accuracy for diagnosis of invasive breast cancer', 'description': 'Accuracy (proportion of true positive and true negative out of total number assessed) of CEM in comparison with standard diagnostic approach.', 'timeFrame': 'Day 1, at time of diagnosis'}, {'measure': 'Time to diagnosis', 'description': 'Time from diagnostic procedure to knowledge of test result by the treating clinician', 'timeFrame': 'Day 1, at time of diagnosis'}, {'measure': 'Proficiency in testing using CEM platform', 'description': 'Proportion of personnel of varying laboratory experience and training modalities with proficiency using CEM platform', 'timeFrame': 'Day 1, At completion of training'}] | SecondaryOutcomes: [{'measure': 'Accuracy for sub-type diagnosis (aggressive vs. indolent) of non-Hodgkin lymphoma', 'description': 'Accuracy (proportion of true positive and true negative out of total number non-Hodgkin lymphoma) of CEM in comparison with standard diagnostic approach.', 'timeFrame': 'Day 1, at time of diagnosis'}, {'measure': 'Accuracy for molecular subtype diagnosis of invasive breast cancer', 'description': 'Accuracy (proportion of true positive and true negative out of total number of invasive breast cancers), compared with standard diagnostic approach, for the molecular subtype diagnosis of invasive breast cancer into estrogen-receptor positive, triple-negative, and other estrogen-receptor negative categories.', 'timeFrame': 'Day 1, at time of diagnosis'}]
Title: A Phase 1 Study to Evaluate the Safety of OBP-301, Telomelysin in Combination With Radiation Therapy in Patients With Esophageal Cancer Not Applicable for Standard Therapy | Condition: Esophageal Cancer | Keywords: esophageal cancer, OBP-301, radiation, Telomelysin, radiotherapy, oncolytic, virotherapy, loco regional | Summary: | Description: After screening, patients will undergo a combination therapy of OBP-301 with radiation therapy for 6 weeks. At Day 1, Day 18 and Day 32, OBP-301 is directly injected to the location of the lesion. From Day 4, patients receive radiation therapy. Patients will be automatically entered follow-up period for 12 weeks to be observed tolerance and safety. This study is designated as standard 3 + 3 dose escalation study. The first 3 patients will be evaluated with low-dose of OBP-301 and then the study move onto the high-dose cohort of OBP-301. When the DLT (Dose Limiting Toxicity) is observed, 3 more patients will be enrolled in the dose level. | ArmGroups: [{'label': 'OBP-301 + Radiation', 'type': 'EXPERIMENTAL', 'description': 'OBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks.', 'interventionNames': ['Biological: OBP-301', 'Radiation: Radiation']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'OBP-301', 'description': 'OBP-301 administration on the Day 1, Day 18 and Day 32', 'armGroupLabels': ['OBP-301 + Radiation']}, {'type': 'RADIATION', 'name': 'Radiation', 'description': 'Standard radiation therapy for esophageal cancer patient. total 60 Gy for 6 weeks', 'armGroupLabels': ['OBP-301 + Radiation']}] | PrimaryOutcomes: [{'measure': 'Occurrence of Dose Limiting Toxicity', 'description': 'Occurrence of Dose Limiting Toxicity for study period to see safety and tolerability of OBP-301 combined with radiation therapy', 'timeFrame': '18 weeks'}, {'measure': 'Incidence rate of adverse event', 'description': 'Incidence rate of adverse event for study period to see safety and tolerability of OBP-301 combined with radiation therapy', 'timeFrame': '18 weeks'}] | SecondaryOutcomes: [{'measure': 'Tumor response in the treatment objected lesion', 'description': 'Tumor response in the treatment objected lesion within 18 weeks from the start of treatment.', 'timeFrame': '18 weeks'}, {'measure': 'Tumor response', 'description': 'Tumor response as the best overall response of the record within 18 weeks from the start of treatment.', 'timeFrame': '18 weeks'}]
Title: "Cross" Closure for Reconstructing the Perineal Wound of Abdominoperineal Resection in Rectal and Anal Cancer Patients: a Multi-center, Randomized, Open-Label, Positive, Parallel Controlled Clinical Trial | Condition: Rectal Cancer, Anal Canal Cancer | Keywords: Traditional closure, "Cross" closure, Rectal cancer, Anal canal cancer, Abdominoperineal resection | Summary: | Description: Perineal wound problems after abdominoperineal resection (APR) for rectal cancer is reported in up to 25%～66% of patients,if the perineum does not heal primarily, the secondary wound healing may prolong hospital stay, may necessitate surgical reintervention, and often requires intensive wound care for several months. Great efforts have been taken to reduce the complications of perineal wound of APR, but the incidence of the perineal wound complications are not effectively decreased. It was reported that one of the most important factors to determine the primary healing of perineal wound is whether the anterior sacral drainage and perineal stump drainage are sufficient and effective or not, which is similar to the concept of closure of enterostomy. Previously, it was reported that "cross" closure is an effective method of skin closure for stoma reversal, which allows increased surgical exposure, reduces suture, smooth drainage, aesthetic healing simplifies wound care, and gives a neat cosmetic result. Therefore, because of the success use of "cross" closure in stoma reversal to reduce the complications of perineal wound, the investigator used the "cross" closure to reconstruct the perineal wound of APR, and it really can decrease the complications of perineal wound. However, more clinical trails are needed to confirm the conclusion. | ArmGroups: [{'label': 'Traditional Closure', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients receive primary closure discontinuously for reconstruction of APR perineal wound', 'interventionNames': ['Procedure: Traditional Closure']}, {'label': '"Cross" Closure', 'type': 'EXPERIMENTAL', 'description': 'Patients receive "cross" closure for reconstruction of APR perineal wound', 'interventionNames': ['Procedure: "Cross" closure']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Traditional Closure', 'description': 'Primary closure discontinuously the perineal wound of APR', 'armGroupLabels': ['Traditional Closure']}, {'type': 'PROCEDURE', 'name': '"Cross" closure', 'description': 'Two triangles of skin in the horizontal direction are excised to enlarge the skin incision, and the tumor resected. Then circumferential subcuticular suture of wound, and with tightening of the circumferential suture, the wound resembles a cross.', 'armGroupLabels': ['"Cross" Closure']}] | PrimaryOutcomes: [{'measure': 'Complication rate of perineal wound', 'description': 'the complications of perineal wound are include wound infection, wound effusion, wound liquefaction, wound dehiscence, seroma or hematoma ,delayed wound healing, presacral or perineal abscess, perineal or pelvic floor hernia', 'timeFrame': 'Within 30 days after operation'}] | SecondaryOutcomes: [{'measure': 'Primary wound healing rate', 'description': 'the Primary wound healing rate within 30 days after operation', 'timeFrame': 'Within 30 days after operation'}, {'measure': 'CTCAE grade for complications of perineal wound', 'description': 'the CTCAE grade for complications of perineal wound within 30 days after surgery', 'timeFrame': 'Within 30 days after surgery'}, {'measure': 'The incidence of each complication of perineal wound', 'description': 'The incidence of each complication of perineal wound within 30 days after surgery', 'timeFrame': 'Within 30 days after surgery'}, {'measure': 'The rate of reoperation', 'description': 'The rate of reoperation within 30 days after surgery', 'timeFrame': 'Within 30 days after surgery'}, {'measure': 'The volumes of presacral drainage', 'description': 'The volumes of presacral drainage within 3, 5, 7 days after surgery', 'timeFrame': 'Within 3, 5, 7 days after surgery'}, {'measure': 'The volumes of presacral residual cavity hydrops', 'description': 'The volumes of presacral residual cavity hydrops within 3 and 7 days postoperatively', 'timeFrame': '3 and 7 days postoperatively'}, {'measure': 'The times of dressing change of perineal wound', 'description': 'The times of dressing change of perineal wound within 3, 5, 7 days after surgery', 'timeFrame': 'Within 3, 5, 7 days after surgery'}, {'measure': 'Removal time of presacral drainage tube', 'description': 'Removal time of presacral drainage tube within 30 days after surgery', 'timeFrame': 'Within 30 days after surgery'}, {'measure': "Scar scores for perineal wound and evaluation of patients' overall satisfaction", 'description': "Scar scores for perineal wound and evaluation of patients' overall satisfaction within 30 days after surgery", 'timeFrame': 'Within 30 days after surgery'}, {'measure': 'Hospital stay after surgery', 'description': 'Hospital stay after surgery within 30 days after surgery', 'timeFrame': 'Within 30 days after surgery'}, {'measure': 'The operation time', 'description': 'The operation time', 'timeFrame': 'Intraoperatively'}]
Title: A Pilot Study of 68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients | Condition: Lung Neoplasms | Keywords: | Summary: | Description: Conventional 18F-FDG PET/CT has important diagnostic value in cell metabolism level, early metastasis, judging malignant potential and prognosis of tumors. It has been routinely used for staging and restaging of most tumors, but there are still some tumors with low uptake of 18F-FDG PET/CT. Moreover, 18F-FDG cannot distinguish between tumors and inflammatory diseases, such as tuberculosis and granuloma. Receptor imaging with a single target also has some limitations in clinical application. For example, not all diseased cells express a large amount of single receptor on the surface, which greatly affects the judgment of the nature of the lesion. The dual-target molecular imaging based on FAP expressed in the lesion site and integrin αvβ3 receptor highly expressed on the surface of the lesion neovascularization will overcome the above limitations and make full use of the advantages of the dual-target molecular imaging, which will greatly assist the diagnosis of malignant tumors such as lung cancer. In this study, a novel dual-target imaging agent 68Ga-FAPI-RGD was used for PET/CT imaging of lung cancer, compared with conventional 18F-FDG, or single target imaging agent 68Ga-RGD or 68Ga-FAPI PET/CT imaging. | ArmGroups: [{'label': '68Ga-FAPI-RGD and 18F-FDG PET/ CT scan', 'type': 'EXPERIMENTAL', 'description': 'Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 18F-FDG, respectively.', 'interventionNames': ['Drug: 68Ga-FAPI-RGD', 'Drug: 18F-FDG']}, {'label': '68Ga-FAPI-RGD and 68Ga-FAPI PET/ CT scan', 'type': 'EXPERIMENTAL', 'description': 'Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-FAPI, respectively.', 'interventionNames': ['Drug: 68Ga-FAPI-RGD', 'Drug: 68Ga-FAPI']}, {'label': '68Ga-FAPI-RGD and 68Ga-RGD PET/ CT scan', 'type': 'EXPERIMENTAL', 'description': 'Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-RGD, respectively.', 'interventionNames': ['Drug: 68Ga-FAPI-RGD', 'Drug: 68Ga-RGD']}] | Interventions:[{'type': 'DRUG', 'name': '68Ga-FAPI-RGD', 'description': 'Intravenous injection of 68Ga-FAPI-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/kg.', 'armGroupLabels': ['68Ga-FAPI-RGD and 18F-FDG PET/ CT scan', '68Ga-FAPI-RGD and 68Ga-FAPI PET/ CT scan', '68Ga-FAPI-RGD and 68Ga-RGD PET/ CT scan'], 'otherNames': ['68Ga-FAPI-RGD injection']}, {'type': 'DRUG', 'name': '18F-FDG', 'description': 'Intravenous injection of 18F-FDG with a dosage of approximately 3.7-5.55 MBq (0.1-0.15 mCi)/kg.', 'armGroupLabels': ['68Ga-FAPI-RGD and 18F-FDG PET/ CT scan'], 'otherNames': ['18F-FDG injection']}, {'type': 'DRUG', 'name': '68Ga-FAPI', 'description': 'Intravenous injection of 68Ga-FAPI with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/kg.', 'armGroupLabels': ['68Ga-FAPI-RGD and 68Ga-FAPI PET/ CT scan'], 'otherNames': ['68Ga-FAPI injection']}, {'type': 'DRUG', 'name': '68Ga-RGD', 'description': 'Intravenous injection of 68Ga-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/kg.', 'armGroupLabels': ['68Ga-FAPI-RGD and 68Ga-RGD PET/ CT scan'], 'otherNames': ['68Ga-RGD injection']}] | PrimaryOutcomes: [{'measure': 'Diagnostic performance1', 'description': 'comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 18F-FDG PET/CT', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Diagnostic performance2', 'description': 'comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 68Ga-FAPI PET/CT', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Diagnostic performance3', 'description': 'comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 68Ga-RGD PET/CT', 'timeFrame': 'through study completion, an average of 1 year'}] | SecondaryOutcomes: [{'measure': 'The dosimetry of 68Ga-FAPI-RGD', 'description': 'Measure the distribution of 68Ga-FAPI-RGD in 6-8 lung cancer patients by 3-hour dynamic PET/CT acquisition by dosimetry software', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': '68Ga-FAPI-RGD uptake at different time points', 'description': 'The SUV uptake of tumors and metastases in patients with lung cancer was measured at 1, 2, and 3 hours.', 'timeFrame': 'through study completion, an average of 1 year'}]
Title: Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer | Condition: Urologic Neoplasms | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Zoledronic Acid with Intermittent Hormonal Therapy', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: zoledronic acid']}] | Interventions:[{'type': 'DRUG', 'name': 'zoledronic acid', 'armGroupLabels': ['Zoledronic Acid with Intermittent Hormonal Therapy']}] | PrimaryOutcomes: [{'measure': 'To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.'}] | SecondaryOutcomes: [{'measure': 'To describe the safety and tolerability at this dose and schedule'}]
Title: Collection of Blood, Bone Marrow, Skin, Saliva, and Stool Samples From Healthy Volunteers Used for Comparative Analysis of Myeloid Malignancies | Condition: Myelodysplastic Syndromes | Keywords: Hematopoietic Stem Cell Malignancies, Acute Myeloid Leukemia, DNA methyltransferase inhibitors, Treatment-Related Complications, Cytotoxic Therapy, Natural History | Summary: | Description: Background: * Myelodysplastic syndromes (MDS) are heterogeneous stem cell disorders characterized by ineffective hematopoiesis resulting in cellular dysplasia, peripheral cytopenias, and increased risk for transformation to acute myeloid leukemia (AML). * There are limited treatment options, all of which have unimpressive response rates and limited response durations, with the only potential cure being hematopoietic stem cell transplant (HSCT). Unfortunately, as a disease of the elderly (average age of diagnosis \>65 years), most participants are not eligible for HSCT due to advanced age and other comorbidities. * It is critical we further elucidate the processes that lead to disease manifestation to develop novel therapeutic strategies and alter the natural history of the disease. * In order to understand the biology of the disease, it is critical to have control biospecimens from healthy individuals to delineate the mechanisms driving disease pathogenesis. Objective: -To create a database of analyzed biospecimens collected from healthy volunteers. Eligibility: * Age \>= 18 years old * Healthy volunteers as confirmed by clinical evaluation Design: * This is a trial to analyze samples from healthy volunteers collected at NIH Clinical Center. --Participants = will be asked to provide blood, and/or bone marrow, and other samples (skin biopsy samples, saliva, stool samples). * The total protocol accrual goal is 1,000 participants. Enrollment is expected to take place over approximately 20-50 years. | ArmGroups: [{'label': 'Cohort 1', 'description': 'Healthy volunteers who will donate blood, and/or bone marrow and may donate other samples'}, {'label': 'Cohort 2', 'description': 'Healthy volunteers who will donate stool samples only'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'create a database of analyzed biospecimens', 'description': 'Collection of biospecimens from healthy volunteers.', 'timeFrame': 'ongoing'}] | SecondaryOutcomes: N/A
Title: En-bloc vs Conventional Resection of Primary Bladder Tumor: Prospective Randomized Multicenter Trial | Condition: Bladder Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'En-Bloc TURB', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Device: En-Bloc TURB']}, {'label': 'Conventional TURB', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Device: Conventional TURB']}] | Interventions:[{'type': 'DEVICE', 'name': 'En-Bloc TURB', 'description': "En-bloc resection will be performed at each center based on local clinical practice and available instruments. Laser resection, hydrodissection with HybridKnife® or electric resection are allowed. All procedures, including cTURB, must be performed with an imaging enhancing technique (PDD / NBI at surgeon's discretion). After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible.", 'armGroupLabels': ['En-Bloc TURB']}, {'type': 'DEVICE', 'name': 'Conventional TURB', 'description': 'En-bloc resection will be performed at each center based on local clinical practice and available instruments. After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible.', 'armGroupLabels': ['Conventional TURB']}] | PrimaryOutcomes: [{'measure': 'The pathological staging assessment for eTURB compared to cTURB', 'description': 'The primary objective of the study is to assess whether eBLOC is associated with a higher rate of detrusor muscle in the pathologic specimen, compared to cTURB', 'timeFrame': '4 weeks'}] | SecondaryOutcomes: [{'measure': 'Residual disease within 3 months after initial TURB', 'timeFrame': '3 months'}, {'measure': 'Occurrence of obturator reflex', 'timeFrame': '1 day'}, {'measure': 'Operative time', 'timeFrame': '1 day'}, {'measure': 'Number of participants with bladder perforation', 'timeFrame': '7 days'}, {'measure': 'Upstaging of disease upon second look transurethral resection surgery', 'timeFrame': '6 weeks'}, {'measure': 'Number of participants with obturator reflex', 'timeFrame': '1 day'}, {'measure': 'Number of tumors with evaluable lateral and deep resection margin', 'timeFrame': '4 weeks'}, {'measure': 'Number of tumors with positive lateral and deep resection margin', 'timeFrame': '4 weeks'}, {'measure': 'Number of participants with conversion to other resection technique', 'timeFrame': '1 day'}, {'measure': 'Number of participants with persistent disease at 2nd look TURB', 'timeFrame': '6 weeks'}, {'measure': 'Recurrence-free survival', 'timeFrame': 'up to 5 years'}]
Title: A Phase II Randomised, Placebo-controlled, Multicentre Study in Prostate Cancer Patients With Painful Bone Metastases to Evaluate the Efficacy of Repeated Radium-223 Injections | Condition: Prostate Cancer, Neoplasm Metastasis | Keywords: HRPC, Recurrent Prostate Cancer, Metastatic Cancer | Summary: | Description: Primary objective: To study the biological effectiveness of radium-223 therapy measured as: * Time to occurrence of skeletal-related events(SREs) * Change in bone-specific alkaline phosphatase (bone-ALP) levels Secondary objectives: To study the efficacy of radium-223 therapy in terms of: * Frequency of new SREs * Proportions of patients with an SRE * Proportions of patients with SRE at different time points * Changes of biochemical markers of bone turnover * Treatment response with regard to pain and analgesic use(termed "Palliative effect" in study protocol) * Quality of life assessment * Overall survival To study the safety of the repeated radium-223 regimen Total Enrollment:64 Study start: February 2004 | ArmGroups: [{'label': 'Radium-223 dichloride (Xofigo, BAY88-8223)', 'type': 'EXPERIMENTAL', 'description': 'Each subject receives local filed external beam radiotherapy (EBR) and repeated injections of the investigational drug radium-223 (EBR+Radium-223)', 'interventionNames': ['Drug: Radium-223 dichloride (BAY88-8223)']}, {'label': 'Saline', 'type': 'PLACEBO_COMPARATOR', 'description': 'Each subject receives local filed external beam radiotherapy (EBR) and repeated injections of saline (EBR+placebo)', 'interventionNames': ['Drug: Saline']}] | Interventions:[{'type': 'DRUG', 'name': 'Radium-223 dichloride (BAY88-8223)', 'description': 'Four Radium-223 injections were given at 4-weekly intervals starting after the first fraction of EBR.', 'armGroupLabels': ['Radium-223 dichloride (Xofigo, BAY88-8223)']}, {'type': 'DRUG', 'name': 'Saline', 'description': 'Four Saline injections were given at 4-weekly intervals starting after the first fraction of EBR.', 'armGroupLabels': ['Saline']}] | PrimaryOutcomes: [{'measure': 'Time to occurrence of Skeletal-related Events (SRE)', 'description': 'SREs are defined as: Increase in pain severity index during the last week; Increase in analgesic consumption; Neurological symptoms secondary to skeletal manifestations of prostate cancer; New pathologic bone fractures (vertebral and non-vertebral); Tumour related orthopaedic surgical intervention; Subsequent external beam radiation to relieve skeletal pain; Use of radioisotopes to relieve new skeletal related symptoms; Use of corticosteroids for skeletal pain, at doses aimed for pain palliation; Use of chemotherapy, bisphosphonates, or hormones, for the treatment of skeletal disease progression', 'timeFrame': 'Up to 12 Month'}, {'measure': 'Relative change (%) in bone-ALP levels from baseline to 4 weeks after last injection', 'timeFrame': 'Up to 12 Month'}] | SecondaryOutcomes: [{'measure': 'Number of SREs per patient', 'timeFrame': 'Up to 12 Month'}, {'measure': 'Changes in the levels of biochemical markers of bone formation', 'timeFrame': 'Up to 12 Month'}, {'measure': 'Change in Prostate Specific Antigen (PSA)', 'timeFrame': 'Up to 12 Month'}, {'measure': 'Change in pain level', 'timeFrame': 'Up to 12 Month'}, {'measure': 'Changes in analgesic use during study period', 'timeFrame': 'Up to 12 Month'}, {'measure': 'Changes in Edmonton Symptom Assessment Scale (ESAS) from baseline', 'timeFrame': 'Up to 12 Month'}, {'measure': 'Overall survival', 'timeFrame': 'up to 24 months'}, {'measure': 'Adverse events', 'timeFrame': 'up to 24 months'}, {'measure': 'Clinical laboratory tests including haematology, renal and liver function parameters', 'timeFrame': 'up to 24 months'}]
Title: Safety and Efficacy of SBRT in the Reirradiation for Ultra-central Thoracic Malignant Tumors | Condition: Stereotactic Body Radiation Therapy, Irradiation; Reaction, Thoracic Tumor, Recurrent Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'RADIATION', 'name': 'stereotacitic body radiation therapy', 'description': 'The patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology.'}] | PrimaryOutcomes: [{'measure': 'Toxcicties', 'description': 'Adverse events of radiation of normal tissues (Including lung, trachea, bronchus, esophagus, blood vessels, ribs, spinal cord, brachial plexus).', 'timeFrame': 'From the beginning of the treatment to 3 years after the treatment.'}, {'measure': 'Local control time', 'description': 'The time from the date of SBRT to the date of recurrence of the target tumor or the date of last observation.', 'timeFrame': 'From the beginning of the treatment to 3 years after the treatment.'}] | SecondaryOutcomes: [{'measure': 'Overall survival time', 'description': 'The time from the date of SBRT to the date of death from any cause or the date of last observation.', 'timeFrame': 'From the beginning of the treatment to 3 years after the treatment.'}, {'measure': 'Disease progression time', 'description': 'The time from the date of SBRT to the date of disease progression from any cause or the date of last observation.', 'timeFrame': 'From the beginning of the treatment to 3 years after the treatment.'}]
Title: Reducing Rural Colon Cancer Disparities Through Multi-level Interventions in Follow-up After Abnormal Screening Tests | Condition: Colon Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Primary Care Provider/Staff Participants Interviews', 'description': '* Up to two primary care providers and at least one staff person at each of the 16 clinics, with approximately 5 interviewees per clinic. Eligible providers and staff include physicians, nurse practitioners, nurses, case managers, medical assistants, administrative staff, or other employees of the clinic involved in the cancer screening and follow-up process.\n* If the participant verbally consents, the research team member will conduct an interview with the provider to learn about the current processes used to support and monitor colorectal cancer screening (CRC) from screening initiation through follow-up; assess capacity and interest in implementing Evidence Based Practices for supporting and monitoring CRC screening, including any ideas interviewees have or find appealing; and engage the organizations as partners to build interest, capacity, and infrastructure for future intervention trial and other future studies.', 'interventionNames': ['Other: Primary Care Provider/Staff Participants Interview']}, {'label': 'Patient Participants Interviews', 'description': "* 10 patients across 5 clinics will be recruited for interviews, which will address the patient experience with screening and follow-up.\n* If the participant verbally consents, the research team member will conduct an interview with the patient participant to gain a deeper understanding of the CRC screening process from the patient's perspective; the gaps, challenges, or road blocks/speed bumps to completing CRC screening steps; and what organizations can do better or differently to help people complete the CRC screening process.", 'interventionNames': ['Other: Patient Participant Interview']}, {'label': 'Patient Participants Anonymous Survey', 'description': '-Patient participants will be recruited to take an anonymous mailed survey, which will address patient level barriers to screening and follow-up focusing on out of pocket costs.', 'interventionNames': ['Other: Patient Participant Anonymous Survey']}, {'label': 'Colonoscopy Provider/Staff Participants Interviews', 'description': '* Colonoscopy providers and a staff or mid-level provider in each office will be recruited for interviews.\n* If the participant consents, the research team member will conduct an interview to learn about current processes used to support and monitor colorectal cancer screening from the perspective of gastroenterology/colonoscopy sites and to learn about how gastroenterology/colonoscopy sites communicate and coordinate care with other healthcare organizations and patients to support and monitor colorectal cancer screening.', 'interventionNames': ['Other: Colonoscopy Provider/Staff Participants Interviews']}] | Interventions:[{'type': 'OTHER', 'name': 'Primary Care Provider/Staff Participants Interview', 'description': '-Approximately a 30 minute interview', 'armGroupLabels': ['Primary Care Provider/Staff Participants Interviews']}, {'type': 'OTHER', 'name': 'Patient Participant Interview', 'description': '-Approximately 45-60 minute interview', 'armGroupLabels': ['Patient Participants Interviews']}, {'type': 'OTHER', 'name': 'Patient Participant Anonymous Survey', 'description': '-Survey completion will take approximately 15 minutes', 'armGroupLabels': ['Patient Participants Anonymous Survey']}, {'type': 'OTHER', 'name': 'Colonoscopy Provider/Staff Participants Interviews', 'description': '-Approximately a 30 minute interview', 'armGroupLabels': ['Colonoscopy Provider/Staff Participants Interviews']}] | PrimaryOutcomes: [{'measure': 'Determine current practice and capacity regarding screening and follow-up of colorectal cancer screening at rural health clinics', 'description': '-This will be measured by interviews', 'timeFrame': 'Through completion of study (estimated to be 18 months)'}, {'measure': 'Assess factors that could influence implementation of multi-level EBIs', 'description': '-This will be measured by interviews', 'timeFrame': 'Through completion of study (estimated to be 18 months)'}, {'measure': 'Evaluate the capacity for colonoscopy and diagnostic follow-up by identifying those clinics/practitioners who deliver colonoscopy', 'description': '-This will be measured by interviews', 'timeFrame': 'Through completion of study (estimated to be 18 months)'}, {'measure': 'Assess the care coordination and communication with primary care providers by colonoscopy clinics/practitioners', 'description': '-This will be measured by interviews', 'timeFrame': 'Through completion of study (estimated to be 18 months)'}] | SecondaryOutcomes: N/A
Title: An Open-label, Multi-center, Multi-cohort, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HYP-2090PTSA in Patients With Advanced Solidt Tumors Harboring KRAS Mutation | Condition: Safety, Tolerability, Efficacy | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Test product-HYP-2090PTSA', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Test product: HYP-2090PTSA']}] | Interventions:[{'type': 'DRUG', 'name': 'Test product: HYP-2090PTSA', 'description': 'Dosage form: Capsule. Strength: 2.5 mg, 5 mg. Method of administration: Oral; Dose escalation: a fixed dose QD is planned, and all other dose levels and administration methods are temporary with the exception of the initial dose. Dose expansion: the dose and method of administration are conducted as discussed by the sponsor and investigators.\n\nMedication cycle: Take orally under fasting condition every morning, with 21 days as a cycle (tentative), and continue taking until disease progression, or intolerable toxicity, or withdrawal of informed consent, or treatment with another antitumor drug, or the death of the subject, or loss to follow-up (whichever occurs earliest).', 'armGroupLabels': ['Test product-HYP-2090PTSA']}] | PrimaryOutcomes: [{'measure': 'Recommended phase-2 dose (RP2D)', 'description': 'RP2D should be selected based on a comprehensive assessment of maximum Tolerated dose (MTD), toxicity, pharmacokinetic (PK) profile, and efficacy data', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Number of participants with dose limiting toxicities', 'description': 'Dose-limiting toxicity (DLT) is defined as an adverse event (AE) or clinically Significant abnormal laboratory value occurring in DLT assessment period', 'timeFrame': '24 days'}] | SecondaryOutcomes: [{'measure': 'Number of participants with Adverse Events (AEs)', 'description': 'All patients participating in this study will be assessed for incidence and severity of AEs and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imagings and ophthalmological assessments', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Objective response rate (ORR)', 'description': 'ORR is defined as the proportion of participants with confirmed complete response or partial response', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Progression-free survival (PFS)', 'description': 'Period of time from the start of treatment to tumor progression or death from any cause (whichever occurs first) based on RECIST v1.1', 'timeFrame': 'Approximately 2 years'}]
Title: In Vivo Confocal Microscopy Tumor Atlas Study | Condition: Brain Neoplasms | Keywords: | Summary: | Description: Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. The procedure involves a small endoscope which is placed gently into contact with the tissue, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. It is already in clinical use in the field of gastroenterological endoscopy, and investigational use in laparoscopy, dermatology and gynecology. Further, in recent pilot studies endomicroscopy has also been shown to be feasible in bronchoscopy, robot assisted prostatectomy and neurosurgery.The study will use both endomicroscopy and biopsy to document the histological appearance of a range of neurological tumour types and grades. In subsequent analysis, the confocal image data and corresponding histology data and images will be used to document reliably observable features in the confocal images that are relevant to histopathology interpretation. Relevant images will be selected and discussed by comparison to frozen or permanent section histology for compilation into an atlas documenting comparison for the tumors seen in the study. | ArmGroups: [{'label': 'All patients', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Endomicroscope']}] | Interventions:[{'type': 'DEVICE', 'name': 'Endomicroscope', 'description': 'Endomicroscopic images and biopsies are taken at several positions on the tumor.', 'armGroupLabels': ['All patients']}] | PrimaryOutcomes: [{'measure': 'Generation of an atlas documenting the comparative features of in vivo microscopy versus traditional histopathology of site-matched biopsies across a range of tumor types and grades.', 'timeFrame': 'During surgery'}] | SecondaryOutcomes: [{'measure': 'Test the ability of an expert neuropathologist to predict the outcome of biopsies based on the confocal images collected in vivo.', 'timeFrame': 'One week'}, {'measure': 'Capture usability and workflow aspects for the confocal device.', 'timeFrame': 'During surgery'}]
Title: A Phase III Randomized Study of Patients With High Risk, Hormone-Naive Prostate Cancer: Androgen Blockade With 4 Cycles of Immediate Chemotherapy Versus Androgen Blockade With Delayed Chemotherapy | Condition: Prostate Cancer | Keywords: adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer | Summary: | Description: OBJECTIVES: Primary * Compare the survival of patients with high-risk hormone-naive prostate cancer treated with androgen blockade with concurrent chemotherapy vs delayed chemotherapy. Secondary * Compare biochemical control in patients treated with these regimens. * Determine the toxicity of these regimens in these patients. * Compare the time to clinical failure, as measured by progression on bone scan or CT scan or a prostate-specific antigen (PSA) doubling time of ≤ 32 weeks, in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior therapy (surgery vs radiotherapy and/or brachytherapy vs both), original combined Gleason score (6 vs 7 vs 8-10), and prior vaccine therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive androgen blockade (AB) comprising a luteinizing-hormone releasing-hormone agonist continuously and oral flutamide or oral bicalutamide once daily for at least 1 month. Within 4 weeks of initiation of AB, patients begin chemotherapy. Patients receive 1, and only 1, of the following chemotherapy regimens: * Regimen A: Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV on day 3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. * Regimen B: Patients receive oral estramustine 3 times daily on days 1-5 and paclitaxel IV on days 3, 10, 17, 24, 31, and 38. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity. * Regimen C: Patients receive oral ketoconazole 3 times daily on days 1-7, 15-21, and 29-35; doxorubicin IV on days 1, 15, and 29; vinblastine IV on days 8, 22, and 36; and oral estramustine 3 times daily on days 8-14, 22-28, and 36-42. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity. * Regimen D: Patients receive oral estramustine 3 times daily on days 1-4 and docetaxel IV over 1 hour on days 3, 10, and 17. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. * Regimen E: Patients receive docetaxel IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. * Regimen F: Patients receive docetaxel IV on days 1, 8, and 15. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. * Regimen G: With approval from the protocol chair, patients may receive a regimen that has been demonstrated in a published phase II study to have at least a 50% response rate as measured by PSA decrease from baseline over 2 measurements 28 days apart or a decrease in measurable soft tissue disease by 50% in 2 dimensions. * Arm II: Patients receive AB as in arm I. Patients continue with AB until clinical failure, at which time patients receive chemotherapy as in arm I. Patients who have a response may continue to receive chemotherapy beyond 4 courses. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,050 patients will be accrued for this study within 4-6 years. | ArmGroups: [{'label': 'Androgen blockade + immediate chemotherapy', 'type': 'EXPERIMENTAL', 'description': 'Androgen blockade with immediate chemotherapy', 'interventionNames': ['Drug: bicalutamide', 'Drug: docetaxel', 'Drug: doxorubicin hydrochloride', 'Drug: estramustine phosphate sodium', 'Drug: flutamide', 'Drug: ketoconazole', 'Drug: paclitaxel', 'Drug: releasing hormone agonist therapy', 'Drug: vinblastine sulfate']}, {'label': 'Androgen blockade + delayed chemotherapy', 'type': 'EXPERIMENTAL', 'description': 'Androgen blockade with delayed chemotherapy', 'interventionNames': ['Drug: bicalutamide', 'Drug: docetaxel', 'Drug: doxorubicin hydrochloride', 'Drug: estramustine phosphate sodium', 'Drug: flutamide', 'Drug: ketoconazole', 'Drug: paclitaxel', 'Drug: releasing hormone agonist therapy', 'Drug: vinblastine sulfate']}] | Interventions:[{'type': 'DRUG', 'name': 'bicalutamide', 'armGroupLabels': ['Androgen blockade + delayed chemotherapy', 'Androgen blockade + immediate chemotherapy']}, {'type': 'DRUG', 'name': 'docetaxel', 'armGroupLabels': ['Androgen blockade + delayed chemotherapy', 'Androgen blockade + immediate chemotherapy']}, {'type': 'DRUG', 'name': 'doxorubicin hydrochloride', 'armGroupLabels': ['Androgen blockade + delayed chemotherapy', 'Androgen blockade + immediate chemotherapy']}, {'type': 'DRUG', 'name': 'estramustine phosphate sodium', 'armGroupLabels': ['Androgen blockade + delayed chemotherapy', 'Androgen blockade + immediate chemotherapy']}, {'type': 'DRUG', 'name': 'flutamide', 'armGroupLabels': ['Androgen blockade + delayed chemotherapy', 'Androgen blockade + immediate chemotherapy']}, {'type': 'DRUG', 'name': 'ketoconazole', 'armGroupLabels': ['Androgen blockade + delayed chemotherapy', 'Androgen blockade + immediate chemotherapy']}, {'type': 'DRUG', 'name': 'paclitaxel', 'armGroupLabels': ['Androgen blockade + delayed chemotherapy', 'Androgen blockade + immediate chemotherapy']}, {'type': 'DRUG', 'name': 'releasing hormone agonist therapy', 'armGroupLabels': ['Androgen blockade + delayed chemotherapy', 'Androgen blockade + immediate chemotherapy']}, {'type': 'DRUG', 'name': 'vinblastine sulfate', 'armGroupLabels': ['Androgen blockade + delayed chemotherapy', 'Androgen blockade + immediate chemotherapy']}] | PrimaryOutcomes: [{'measure': 'Overall Survival', 'timeFrame': 'From date of randomization to the date of death due to any cause'}] | SecondaryOutcomes: [{'measure': 'Biochemical control', 'timeFrame': 'From date of randomization to the date of first PSA failure defined as a PSA doubling time <= 32 weeks'}, {'measure': 'Time to Clinical Failure', 'timeFrame': 'Time from study entry to positive scan or positive disease evaluation of the pelvis or chest or a PSA doubling time ≤ 32 weeks'}, {'measure': 'Frequency of non-hematologic (>= grade 3), hematologic (grade >=4) and fatal (grade 5) toxicities', 'timeFrame': 'From the beginning of treatment to 90 days post treatment'}]
Title: Construction of Gynecological Tumor Sample Library | Condition: Gynecologic Cancer | Keywords: | Summary: | Description: This project is the construction and maintenance of a gynecological tumor sample library. It is supported by the National Key Laboratory of Difficult, Severe, and Rare Diseases at Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences. This project will lay a clinical specimen foundation for exploring the molecular mechanisms of gynecological tumors in the future. | ArmGroups: [{'label': 'samples of cervical cancer', 'description': 'fresh samples collected from patients diagnosed with cervical cancer'}, {'label': 'samples of endometrial cancer', 'description': 'fresh samples collected from patients diagnosed with endometrial cancer'}, {'label': 'samples of ovarian cancer', 'description': 'fresh samples collected from patients diagnosed with ovarian cancer'}, {'label': 'samples of vulva cancer', 'description': 'fresh samples collected from patients diagnosed with vulva cancer'}, {'label': 'samples of vaginal cancer', 'description': 'fresh samples collected from patients diagnosed with vaginal cancer'}, {'label': 'samples of rare gynecological cancer', 'description': 'fresh samples collected from patients diagnosed with rare gynecological cancer'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'construction of Biobank', 'description': 'Biobank including gynecolgic cancer samples, including cervical cancer, endometrial cancer, ovarian cancer, vulva cancer, vaginal cancer, and others types', 'timeFrame': '3 years'}] | SecondaryOutcomes: [{'measure': 'Exploring the molecular mechanism based on biobank', 'description': 'Exploring the molecular mechanism of gynecological tumor pathogenesis based on biobank', 'timeFrame': '3 year'}, {'measure': 'Drug sensitivity detection based on biobank', 'description': 'Exploring drug sensitivity detection in gynecological tumors based on biobank', 'timeFrame': '3 year'}]
Title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 in Combination With Other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous MTAP-deletion | Condition: Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers | Keywords: Advanced Cancer, Methylthioadenosine Phosphorylase, AMG 193, Oncology | Summary: | Description: N/A | ArmGroups: [{'label': 'Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A', 'type': 'EXPERIMENTAL', 'description': 'Part 1: Participants with MTAP-deleted PDAC will receive escalating doses of AMG 193 orally in combination with gemcitabine and nab-paclitaxel IV.\n\nPart 2: Participants with MTAP-deleted PDAC will receive the recommended dose of AMG 193 in combination with gemcitabine and nab-paclitaxel.', 'interventionNames': ['Drug: AMG 193', 'Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}, {'label': 'Subprotocol B: PDAC Arm B', 'type': 'EXPERIMENTAL', 'description': 'Part 1: Participants with MTAP-deleted PDAC will receive escalating doses of AMG 193 orally in combination with mFOLFIRINOX (irinotecan, fluorouracil, leucovorin calcium, oxaliplatin) IV.\n\nPart 2: Participants with MTAP-deleted PDAC will receive the recommended dose of AMG 193 in combination with mFOLFIRINOX.', 'interventionNames': ['Drug: AMG 193', 'Drug: Modified FOLFIRINOX']}] | Interventions:[{'type': 'DRUG', 'name': 'AMG 193', 'description': 'Administered Orally', 'armGroupLabels': ['Subprotocol B: PDAC Arm B', 'Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A']}, {'type': 'DRUG', 'name': 'Gemcitabine', 'description': 'Administered IV', 'armGroupLabels': ['Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A']}, {'type': 'DRUG', 'name': 'Nab-paclitaxel', 'description': 'Administered IV', 'armGroupLabels': ['Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A']}, {'type': 'DRUG', 'name': 'Modified FOLFIRINOX', 'description': 'Modified FOLFIRINOX consists of irinotecan, 5-FU, LV, and oxaliplatin administered IV', 'armGroupLabels': ['Subprotocol B: PDAC Arm B']}] | PrimaryOutcomes: [{'measure': 'Number of Participants Experiencing Dose Limiting Toxicities (DLT)', 'timeFrame': 'Up to 28 days'}, {'measure': 'Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)', 'description': 'Any clinically significant changes in vital signs, electrocardiogram, or lab parameters will be recorded as TEAEs.', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Number of Participants Experiencing Serious Adverse Events (SAE)', 'timeFrame': 'Up to approximately 2 years'}] | SecondaryOutcomes: [{'measure': 'Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Disease Control (DC) per RECIST v1.1', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Duration of Response (DOR) per RECIST v1.1', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Time to Response (TTR) per RECIST v1.1', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Overall Survival (OS) per RECIST v1.1', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Progression-free Survival (PFS) per RECIST v1.1', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Maximum Plasma Concentration (Cmax) of AMG193', 'timeFrame': 'Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)'}, {'measure': 'Time to Maximum Plasma Concentration (tmax) of AMG193', 'timeFrame': 'Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)'}, {'measure': 'Area Under the Plasma Concentration-time Curve (AUC) of AMG 193', 'timeFrame': 'Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)'}]
Title: A Phase 1, Multicenter, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB028 Administered to Subjects With Advanced Solid Tumors | Condition: Advanced Solid Tumors | Keywords: | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'BIIB028', 'description': 'IV infusion administered twice weekly until disease progression or unacceptable toxicity'}] | PrimaryOutcomes: [{'measure': 'Safety and Tolerability of BIIB028', 'timeFrame': 'As specified in Protocol'}] | SecondaryOutcomes: [{'measure': 'PK and PD of BIIB028', 'timeFrame': 'As specified in protocol'}, {'measure': 'Antitumor activity', 'timeFrame': 'As specified in protocol'}]
Title: An Investigator-Sponsored Phase 2 Single Arm Trial of Ramucirumab and Pembrolizumab in Patients With EGFR Mutant Non-Small Cell Lung Cancer | Condition: Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8 | Keywords: | Summary: | Description: PRIMARY OBJECTIVE: I. To evaluate response rate of the combination of ramucirumab and pembrolizumab in EGFR mutant non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVE: I. To evaluate safety, tolerability, and survival for patients receiving pembrolizumab and ramucirumab. EXPLORATORY OBJECTIVE: I. To characterize predictive immunologic biomarkers of response in tissue and peripheral blood of patients receiving ramucirumab and pembrolizumab combination therapy. OUTLINE: Patients receive ramucirumab intravenously (IV) over 60 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 3 months for 1 year, and then every 6 months for 1 year. | ArmGroups: [{'label': 'Treatment (ramucirumab, pembrolizumab)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive ramucirumab IV over 60 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Biological: Pembrolizumab', 'Biological: Ramucirumab']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'Pembrolizumab', 'description': 'Given IV', 'armGroupLabels': ['Treatment (ramucirumab, pembrolizumab)'], 'otherNames': ['Keytruda', 'Lambrolizumab', 'MK-3475', 'SCH 900475']}, {'type': 'BIOLOGICAL', 'name': 'Ramucirumab', 'description': 'Given IV', 'armGroupLabels': ['Treatment (ramucirumab, pembrolizumab)'], 'otherNames': ['anti-VEGFR-2 fully human monoclonal antibody IMC-1121B', 'Cyramza', 'IMC-1121B', 'LY3009806', 'Monoclonal Antibody HGS-ETR2']}] | PrimaryOutcomes: [{'measure': 'Overall response rate', 'description': 'Response rate will be evaluated with computed tomography (CT) scans every 2 cycles and tumor measurements using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Immune RECIST (iRECIST) will also be assessed.', 'timeFrame': 'Up to 2 years'}] | SecondaryOutcomes: [{'measure': 'Incidence of adverse events', 'description': 'Common Terminology Criteria for Adverse Events version 4.0 will be used for adverse event grading. Attributions of causality will be assessed by the primary treating physician. Frequency and severity of adverse events and tolerability of the regimen will be collected and summarized by descriptive statistics for each of the disease cohorts.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Clinical benefit rate (complete response + partial response + stable disease)', 'description': 'Clinical benefit rate will be evaluated with CT scans every 2 cycles and tumor measurements using RECIST 1.1 criteria. iRECIST will also be assessed.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Progression-free survival', 'description': 'Kaplan-Meier curves will be calculated to estimate progression-free survival.', 'timeFrame': 'From the date of study registration to the date of progressive disease, assessed up to 2 years'}, {'measure': 'Overall survival', 'description': 'Kaplan-Meier curves will be calculated to estimate overall survival.', 'timeFrame': 'From the date of study registration to the date of death, assessed up to 2 years'}]
Title: Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer | Condition: Head and Neck Cancer, Multiparametric MRI, Cervical Lymph Node | Keywords: | Summary: | Description: Background:The locoregional control rates in patients with advanced head and neck cancer remain suboptimal. Accurate diagnosis of metastatic cervical lymph nodes remains challenging. Technological advances in magnetic resonance imaging (MRI) enable to quantify diffusion and perfusion of the tumour and its surrounding tissues, which could improve diagnostic performance. Objectives: The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region. Study design: a retrospective study will be set up to explore the diagnostic performance of the selected MRI parameters to differentiate between tumoural and non-tumoural cervical lymph nodes in patients with a histologically confirmed head and neck tumour ('affected group') or histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation ('control group'). Patients will be screened for inclusion in the analysis if they had a routine preoperative multiparametric MRI, according to a standardised protocol, between the 1st of December 2016 and the 30th of September 2018. All MR images will be screened by the resident to select those patients with one or multiple clearly distinguishable metastatic cervical lymph node(s), which can be clearly correlated with the final pathology report. Other strict inclusion criteria are described in detail in the protocol. | ArmGroups: [{'label': 'affected', 'description': 'patients with a histologically confirmed head and neck tumour', 'interventionNames': ['Other: multiparametric MRI']}, {'label': 'control', 'description': 'histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation', 'interventionNames': ['Other: multiparametric MRI']}] | Interventions:[{'type': 'OTHER', 'name': 'multiparametric MRI', 'description': 'preoperative multiparametric MRI', 'armGroupLabels': ['affected', 'control']}] | PrimaryOutcomes: [{'measure': 'discriminatory value of MRI perfusion curve', 'description': "differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'", 'timeFrame': 'preoperative'}, {'measure': 'discriminatory value of MRI ADC', 'description': "differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'", 'timeFrame': 'preoperative'}, {'measure': 'discriminatory value of MRI D-value', 'description': "differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'", 'timeFrame': 'preoperative'}] | SecondaryOutcomes: N/A
Title: Detecting Recurrent Prostate Cancer With C-11 Choline Positron Emission Tomography: An Expanded Access Study | Condition: Cancer of the Prostate | Keywords: Recurrent | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'C-11 Choline PET Imaging', 'description': 'Patients will receive IV injection of C-11 Choline followed by imaging from the base of the brain to the upper thigh on a PET/CT or a PET/MRI scanner'}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A
Title: Impact of ICU on the Quality of Life and Oncological Care of Patients With Solid Tumors | Condition: Solid Tumor, Adult | Keywords: Quality of life, Oncological care, intensive care unit, solid tumor | Summary: | Description: Inclusion of cancer patients (cases) at discharge of surgical, cardiovascular and thoracic and medical ICU of the Grenoble Alpes University Hospital. Cases will be matched with cancer patients identified in oncologist's consultation. Inclusion of controls from oncologist consultations (2 controls for 1 case) For cases and controls, medical data will be collected at inclusion, 3 and 6 months. | ArmGroups: [{'label': 'Cases', 'description': '* \\> 18 years old\n* Non-opposition of the patient or relatives\n* Lung, head and neck or colorectal cancer\n* Non scheduled ICU admission\n* At least 24 hours of ICU stay\n* Alive at ICU discharge\n* Able to answer by phone to quality of life questionary', 'interventionNames': ['Other: Questionnaires']}, {'label': 'Controls', 'description': 'Cancer patients not admitted in ICU, matched with the cases according to\n\n* the type of primary cancer\n* the presence or absence of oncogenic addiction\n* the setting of anticancer treatment (curative/palliative)\n* the line of anticancer treatment (none/L1/L2-L3/\\>L3).', 'interventionNames': ['Other: Questionnaires']}] | Interventions:[{'type': 'OTHER', 'name': 'Questionnaires', 'description': 'Quality of life questionary: 36-Item Short Form Survey Instrument (36-SF) at 3 and 6 months from inclusion By phone', 'armGroupLabels': ['Cases', 'Controls']}] | PrimaryOutcomes: [{'measure': 'quality of life questionary 36-item short form survey instrument (36-SF)', 'description': 'score of 0 (poor quality of life) to 100 (very good quality of life)', 'timeFrame': '3 months'}] | SecondaryOutcomes: [{'measure': 'intensity of antitumoral treatment compared to standard treatment', 'description': 'standard treatment vs adaptated treatment vs palliative care standard treatment was defined by the treatment recommended in the ESMO guidelines for each cancer (lung, colorectal, and head and neck cancer)', 'timeFrame': '3 months'}, {'measure': 'quality of life questionary 36-item short form survey instrument (36-SF)', 'description': 'score of 0 (poor quality of life) to 100 (very good quality of life)', 'timeFrame': '6 months'}, {'measure': 'intensity of antitumoral treatment compared to standard treatment', 'description': 'standard treatment vs adaptated treatment vs palliative care standard treatment was defined by the treatment recommended in the ESMO guidelines for each cancer (lung, colorectal, and head and neck cancer)', 'timeFrame': '6 months'}, {'measure': 'ECOG - Performance status', 'description': 'From 0 (fully active) to 5 (dead)', 'timeFrame': '3 months and 6 months'}, {'measure': 'Activities of Daily Living', 'description': 'From 0 (dependent ) to 6 (autonomous)', 'timeFrame': '6 months'}, {'measure': 'Hospital Anxiety and Depression Scale', 'description': 'Anxiety scale from 0 (no anxiety) to 21 (anxiety) Depression Scale from 0 (no depression) to 21 (depression)', 'timeFrame': '3 months and 6 months'}]
Title: Colorectal Cancer Screening in Familiar-Risk Population: a Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy | Condition: Colorectal Cancer | Keywords: FOBT, colonoscopy, familiar risk, colorectal cancer, advanced adenoma | Summary: | Description: This is an observational, controlled, randomized phase III study to evaluate the effectiveness of the iFOBT for detecting advanced neoplasia (polyps \> 1cm in size, high grade dysplasia or with villous component, or CRC) in first degree relatives of patients with CRC. Index cases will be interviewed to obtain the family tree and their first-degree relatives will be contacted to invite them to participate in the study. Index-cases, will be randomized into one of the following two groups in order that their relatives receive the same screening strategy: A) colonoscopy; or B) annual iFOBT test (OC-Sensor®, cut off ≥50 ng/ml) and colonoscopy if positive. To determine the sensitivity and specificity of the iFOBT strategy, individuals randomized to group B will be invited to undergo a complete colonoscopy following two years follow-up. In addition, epidemiological data, personal history of disease, family history of neoplasm, characteristics of lesions at colonoscopy and histological diagnosis will be recorded. To test the hypothesis of equivalence between the iFOBT test and colonoscopy for detecting advanced colorectal neoplasm, it was considered a probability of participation, detection capability and prevalence of advanced adenomas for iFOBT of 0.750, 0.565 and 0.077, respectively, being the product of them 0.033. In the case of colonoscopy, the likelihood of participation, detection capability and prevalence of advanced adenomas in this population at risk are 0,500, 0.965 and 0.077, respectively, and their product 0.037. Accordingly, for a Type I error (alpha) of 5%, a power of 80% and a maximum deviation between the probabilities of the two tests of 0.03 the number of subjects to be included per arm is 744 | ArmGroups: [{'label': 'Fecal occult blood testing', 'type': 'EXPERIMENTAL', 'description': 'Immunochemical fecal occult blood test Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml.', 'interventionNames': ['Procedure: Immunochemical fecal occult blood test And colonoscopy if test is positive']}, {'label': 'Colonoscopy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Colonoscopy with sedation.', 'interventionNames': ['Procedure: Colonoscopy with sedation']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Immunochemical fecal occult blood test And colonoscopy if test is positive', 'description': 'Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml.', 'armGroupLabels': ['Fecal occult blood testing']}, {'type': 'PROCEDURE', 'name': 'Colonoscopy with sedation', 'description': 'Colonoscopy with sedation', 'armGroupLabels': ['Colonoscopy']}] | PrimaryOutcomes: [{'measure': 'Advanced colorectal neoplasm detection rate [Time Frame: 2 years] [Designated as safety issue: No]', 'timeFrame': '2 years'}] | SecondaryOutcomes: [{'measure': 'Complications rate', 'timeFrame': '2 years'}]
Title: A Phase 1, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of an Anti-Claudin 18.2 Antibody SPX-101 in Patients With Advanced or Refractory Solid Tumors | Condition: Solid Tumors | Keywords: | Summary: | Description: This is an open-label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of various doses of SPX-101 in patients with advanced or refractory solid tumors. This study will determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase2 dose (RP2D). Up to five dose levels will be explored (1, 3, 9, 18, 30 mg/kg dose levels) depending on the number and intensity of observed toxicities. A total of up to 27 patients will be enrolled in this study. Subjects will receive SPX-101 by IV infusion in 60-minutes（±15 minutes）on Day 1 of the first cycle (3 weeks), and will be evaluated for DLTs in 3 weeks (DLT window). After the first cycle, subjects will continue the treatment at the assigned dose level. | ArmGroups: [{'label': 'SPX-101', 'type': 'EXPERIMENTAL', 'description': 'A total of up to 27 patients will be enrolled in this study. Subjects will receive SPX-101 by IV infusion in 60-minutes（±15 minutes）on Day 1 of the first cycle (3 weeks), and will be evaluated for DLTs in 3 weeks (DLT window). After the first cycle, subjects will continue the treatment at the assigned dose level.', 'interventionNames': ['Biological: SPX-101']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'SPX-101', 'description': 'Subjects will receive SPX-101 on Day 1 of the first cycle, and will be evaluated for DLTs in the following 3 weeks. After the first cycle, subjects will continue treatment at dosing intervals as determined by safety and PK results. All patients will continue treatment until disease progression, development of unacceptable toxicity, or until in the opinion of the investigator the patient is no longer benefiting from therapy, or at patient discretion (maximum duration: 2 years).', 'armGroupLabels': ['SPX-101']}] | PrimaryOutcomes: [{'measure': 'To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and select the recommended Phase 2 dose (RP2D).', 'description': 'First-cycle dose limiting toxicities (DLTs). Adverse events as characterized by type, frequency, severity (as graded by NCI Common Terminology Criteria for Adverse Events (CTCAE) v.5.0), timing, seriousness and relationship to study therapy.', 'timeFrame': 'The analysis will extend through 28 days after the last administration of study drug.'}, {'measure': 'To determine the safety and tolerability of SPX-101 in patients with solid tumors', 'description': 'First-cycle dose limiting toxicities (DLTs). Adverse events as characterized by type, frequency, severity (as graded by NCI Common Terminology Criteria for Adverse Events (CTCAE) v.5.0), timing, seriousness and relationship to study therapy.', 'timeFrame': 'The analysis will extend through 28 days after the last administration of study drug.'}] | SecondaryOutcomes: [{'measure': 'To measure Area Under Curve (AUC)', 'description': 'characterization of the pharmacokinetics (PK)', 'timeFrame': 'The analysis will extend through 28 days after the last administration of study drug.'}, {'measure': 'To measure plasma clearance rate (CL)', 'description': 'characterization of the pharmacokinetics (PK)', 'timeFrame': 'The analysis will extend through 28 days after the last administration of study drug.'}, {'measure': 'To measure minimum concentration (Cmin)', 'description': 'characterization of the pharmacokinetics (PK)', 'timeFrame': 'The analysis will extend through 28 days after the last administration of study drug.'}, {'measure': 'To measure maximum concentration (Cmax)', 'description': 'characterization of the pharmacokinetics (PK)', 'timeFrame': 'The analysis will extend through 28 days after the last administration of study drug.'}, {'measure': 'To measure half-life (T1/2)', 'description': 'characterization of the pharmacokinetics (PK)', 'timeFrame': 'The analysis will extend through 28 days after the last administration of study drug.'}, {'measure': 'To measure apparent volume of distribution (Vd)', 'description': 'characterization of the pharmacokinetics (PK)', 'timeFrame': 'The analysis will extend through 28 days after the last administration of study drug.'}, {'measure': 'To assess Anti-Drug Antibody (ADA)', 'description': 'evaluating Immunogenicity', 'timeFrame': 'The analysis will extend through 28 days after the last administration of study drug.'}, {'measure': 'Objective response rate (ORR), as assessed by Response Evaluation Criteria in Solid Tumor (RECIST) version1.1', 'description': 'To evaluate antitumor efficacy', 'timeFrame': 'The analysis will extend through 28 days after the last administration of study drug.'}, {'measure': 'Disease control rate (DCR), as assessed by Response Evaluation Criteria in Solid Tumor (RECIST) version1.1', 'description': 'To evaluate antitumor efficacy', 'timeFrame': 'The analysis will extend through 28 days after the last administration of study drug.'}, {'measure': 'Duration of response (DOR), as assessed by Response Evaluation Criteria in Solid Tumor (RECIST) version1.1', 'description': 'To evaluate antitumor efficacy', 'timeFrame': 'The analysis will extend through 28 days after the last administration of study drug.'}, {'measure': 'Progression free survival (PFS), as assessed by Response Evaluation Criteria in Solid Tumor (RECIST) version1.1.', 'description': 'To evaluate antitumor efficacy', 'timeFrame': 'The analysis will extend through 28 days after the last administration of study drug.'}]
Title: Improvement of Quality of Life (QoL) Using Preference-Oriented QoLMonitoring and Linkage with Clinical Registry Data: Randomised Clinical Trial in Patients with Lung Cancer | Condition: Lung Cancer, Quality of Life | Keywords: quality of life, lung cancer, definitive randomised controlled trial, patient empowerment, quality of life monitoring, patient and physician preferences | Summary: | Description: A pathway with quality of life (QoL) diagnosis and therapeutic options for patients with breast cancer and colorectal cancer has been successfully designed, implemented, and evaluated as guided by the Medical Research Council framework for developing and testing complex interventions. In two randomised controlled trials the investigators could demonstrate that patients with breast cancer and colorectal cancer had a benefit from the diagnosis of QoL deficits and tailored therapeutic options in their treatment in terms of a decrease in QoL deficits. The next step is to extend usability of the QoL system so that it can be as well used by patients with other cancer diagnoses and in other study regions. Therefore, QoL will be assessed using an electronic patient- and physician-centered QoL monitoring system which is based on previous work of the research group. The QoL monitoring system is adapted based on results of a preliminary study using discrete choice experiments (DCE) identifying preferences of lung cancer patients and their physicians regarding the importance of individual QoL dimensions. In this two-arm randomised, controlled, prospective, pragmatic, multicentre clinical trial with one intervention group and one control group QoL of primary lung cancer patients will be assessed with an electronic patient- and physician-centered QoL monitoring system using the quality of life questionnaires (QLQ) of the European Organisation for Research and Treatment of Cancer EORTC QLQ-C30 (core module) and QLQ-LC29 (lung cancer module) at study entry and at 1, 2, 3, 4, 5, and 6 months during follow-up care. Data of each patient's QoL will be linked with clinical data from the Bavarian Cancer Registry for the purpose of data analysis. In the intervention group results of QoL monitoring are automatically transferred to a preference-based QoL profile including 8 dimensions on scales of 0-100 (cutoff of a "need for QoL therapy" \<50). Patients and their treating physicians receive the results of their QoL monitoring in real-time. In order to be able to treat QoL deficits a multi-professional network of therapists is established (e.g. pain therapy, psychotherapy, social support, nutrition counselling, physiotherapy, fitness, respiratory therapy, palliative care). In the intervention group patients and their physicians receive complete lists of QoL healthcare professionals of this network practicing in their region. In the control group QoL is also measured but neither patients nor treating physicians have access to the results of QoL monitoring, but the therapist network is also available for this study arm. The investigators expect that the proportion of patients in both groups with a need for QoL therapy (\<50 points in at least one dimension of the QoL profile) will be lower in intervention group patients compared with control group patients at the primary endpoint 6 months after study entry. | ArmGroups: [{'label': 'Patient- and physician-centered QoL monitoring', 'type': 'EXPERIMENTAL', 'description': 'Quality of life (QoL) of patients is assessed with an electronic patient- and physician-centered QoL monitoring system using the questionnaires EORTC QLQ-C30 and QLQ-LC29 at study entry and at 1, 2, 3, 4, 5, and 6 months during follow-up care. Results of QoL monitoring are automatically transferred to a QoL profile. Patients and their treating physicians receive the results of their QoL monitoring in real-time. In order to be able to treat QoL deficits a multiprofessional network of therapists is established (e.g. pain therapy, psychotherapy, social support, nutrition counselling, physiotherapy, fitness, respiratory therapy). Intervention group physicians and patients receive complete lists of QoL healthcare professionals of this network practicing in their region. To provide continuous medical education, quality circles for therapy options have been founded.', 'interventionNames': ['Behavioral: patient- and physician-centered QoL monitoring']}, {'label': 'Routine care', 'type': 'PLACEBO_COMPARATOR', 'description': 'QoL of patients is also assessed with the same QoL monitoring system used in the intervention group at study entry and at 1, 2, 3, 4, 5, and 6 months but neither patients nor treating physicians have access to the QoL profiles. The therapist network is also available for control arm.', 'interventionNames': ['Other: Placebo']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'patient- and physician-centered QoL monitoring', 'description': 'Electronic QoL monitoring including QoL diagnosis and therapy (pain therapy, psychotherapy, social support, nutrition, physiotherapy, fitness, respiratory counselling, palliative care). Patients and treating physicians have access to the results of their QoL monitoring and to a network of local healthcare providers.', 'armGroupLabels': ['Patient- and physician-centered QoL monitoring']}, {'type': 'OTHER', 'name': 'Placebo', 'description': 'Electronic QoL monitoring without QoL diagnosis and therapy. Patients and treating physicians have no access to the results of their QoL monitoring. The therapist network is also available for control arm.', 'armGroupLabels': ['Routine care']}] | PrimaryOutcomes: [{'measure': 'Proportion of patients with a need for QoL therapy in at least one dimension of the QoL profile at 6 months', 'description': 'proportion of patients in both groups with a need for QoL therapy (\\<50 points) in at least one of eight dimensions of the QoL profile: global quality of life, shortness of breath, physical functioning, social functioning, fear of progression, emotional functioning, pain, financial impact', 'timeFrame': '6 months after study entry'}] | SecondaryOutcomes: [{'measure': 'Proportion of patients with a need for QoL therapy in each dimension of the QoL profile at 1, 2, 3, 4, 5, and 6 months', 'description': 'proportions of patients with a need for QoL therapy (\\<50 points) in each single dimension of the QoL profile: global quality of life, shortness of breath, physical functioning, social functioning, fear of progression, emotional functioning, pain, financial impact', 'timeFrame': '1, 2, 3, 4, 5, 6 months after study entry'}]
Title: ASPIRES (Activating Cancer Survivors and Their Primary Care Providers to Increase Colorectal Cancer Screening) Study | Condition: Colorectal Cancer, Early Detection of Cancer | Keywords: Colorectal cancer, cancer survivor | Summary: | Description: This is a 12-month, 3-arm randomized controlled trial of 315 Childhood Cancer Survivor Study (CCSS) survivors using a text message intervention with data collected at baseline and 12 months through patient and provider surveys and interviews and a medical record review. Participants will be randomly assigned to one of three groups: control, patient activation (PA) using a text message/video intervention, or patient activation + primary care provider activation (PA + PCP) which will include providing primary care providers with resources about colorectal cancer risk in this population. All participants will receive electronic resources about their previous cancer treatment and colorectal cancer screening recommendations. The primary outcome is the proportion of patients who complete the colonoscopy or Cologuard test (Cologuard test plus colonoscopy if the Cologuard is positive) within 12 months of enrolling on the study, as measured via self-report questions in the end of study questionnaire. The study will test the hypothesis that, compared to controls, survivors randomized to the PA and PA + PCP activation groups will have significantly higher rates of completion of colorectal cancer screening. | ArmGroups: [{'label': 'Group1: Control (C)', 'type': 'EXPERIMENTAL', 'description': 'Electronic educational materials (C).', 'interventionNames': ['Behavioral: Control']}, {'label': 'Group 2: Patient Activation (PA)', 'type': 'EXPERIMENTAL', 'description': 'C + patient activation (PA) consisting of interactive tailored text messages with links to videos and resources', 'interventionNames': ['Behavioral: Control', 'Behavioral: Patient activation']}, {'label': 'Group 3: Patient Activation and PCP Activation (PA + PCP)', 'type': 'EXPERIMENTAL', 'description': 'C + PA + PCP activation (PA+PCP) with physician materials about colorectal cancer risk in this population', 'interventionNames': ['Behavioral: Control', 'Behavioral: Patient activation', 'Behavioral: Primary care provider activation']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Control', 'description': 'Electronic educational materials', 'armGroupLabels': ['Group 2: Patient Activation (PA)', 'Group 3: Patient Activation and PCP Activation (PA + PCP)', 'Group1: Control (C)']}, {'type': 'BEHAVIORAL', 'name': 'Patient activation', 'description': 'Interactive text messages with links to videos (e.g. colorectal cancer screening options, cost of colorectal cancer screening, perspective from a cancer survivor, why regular appointments are important for cancer survivors) and resources (e.g. helpful websites) are sent to participants', 'armGroupLabels': ['Group 2: Patient Activation (PA)', 'Group 3: Patient Activation and PCP Activation (PA + PCP)']}, {'type': 'BEHAVIORAL', 'name': 'Primary care provider activation', 'description': "Faxed educational materials (e.g. current colorectal cancer screening recommendations, frequently asked questions, insurance letter template, cover letter with overview of patient's cancer treatment history) sent to primary care providers", 'armGroupLabels': ['Group 3: Patient Activation and PCP Activation (PA + PCP)']}] | PrimaryOutcomes: [{'measure': 'Proportion of patients who report completing a colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization', 'description': 'This will be measured by self-report on a questionnaire given at 12 months.', 'timeFrame': '12 months'}] | SecondaryOutcomes: [{'measure': 'Proportion of patients who complete the colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization as measured in medical record reports', 'description': 'The study team will confirm if participants had a colonoscopy or cologuard test by reaching out to the medical site where the participant was screened, and requesting the medical record confirmation.', 'timeFrame': '12 months'}, {'measure': 'Potential barriers and facilitators to the uptake of the intervention at both the patient and provider level as measured by CFIR questions', 'description': 'Consolidated Framework for Implementation Research (CFIR) questions are included in the 12-month questionnaire for participants, the 12-month questionnaire for their primary care providers, and the end of study interviews for the participants, primary care providers, and other medical office staff. CFIR questions are meant to measure 5 domains: intervention characteristics, outer setting, inner setting, characteristics of individuals, and process.', 'timeFrame': '14 months'}, {'measure': 'Other potential barriers and facilitators to the uptake of the intervention at both the patient and provider level', 'description': "In this study, the potential moderators include patient characteristics, such as age, gender, educational attainment, health insurance coverage, types of insurance, chronic health conditions, and race/ethnicity as well as PCP factors such as knowledge, years in practice, and practice setting. The potential mediators in this study may include the patient's perception of involvement in decision making, health insurance coverage, and whether the patient reviewed the study resources and videos. This will be measured through data collected via the baseline and 12 month questionnaires as well as data previously collected via the St. Jude Childhood Cancer Survivor Study.", 'timeFrame': '12 months'}, {'measure': 'Cost and Cost-Effectiveness Analysis', 'description': 'We will collect data on the replication costs of the intervention and health services from the intervention per participant. The costs of the intervention (e.g. intervention materials, personnel time, and texting costs) will be collected by the University of Chicago team via a cost spreadsheet. The cost of the health services will be collected via the 12-month questionnaire; participants will be asked to share information about the types of medical visits they have had since joining the study.', 'timeFrame': '12 months'}]
Title: Sentinel Node Detection in Cervical Cancer | Condition: Sentinel Lymph Node Biopsy | Keywords: | Summary: | Description: Consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached for eligibility by defined criteria. Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers. Technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated. An interim analyse will be performed after 34 node positive patients based on the Fleming two stage analyse. The null hypothesis of sensitivity of 85% will be tested against an estimated sensitivity of 95%. At this stage the study may be closed for futility, closed as hull hypothesis is rejected or continued to reach another 28 node positive patients. As a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient will act ast their own controls. | ArmGroups: [{'label': 'prospective cohort study', 'type': 'OTHER', 'description': 'Prospective cohort study with detection of sentinel lymph nodes followed by a full pelvic lymphadenectomy. Patients will act as their own controls.\n\nThe intervention is the detection and removal of sentinel lymph nodes', 'interventionNames': ['Procedure: Sentinel node detection in cervical cancer']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Sentinel node detection in cervical cancer', 'description': 'The study intervention is the injection of tracer followed by detection and removal of sentinel lymph nodes', 'armGroupLabels': ['prospective cohort study']}] | PrimaryOutcomes: [{'measure': 'Sentinel node detection in cervical cancer; Sensitivity and negative predictive values for identifying pelvic nodal disease, See detailed study protocol', 'description': 'Detection of Sentinel nodes followed by full pelvic lymphadenectomy', 'timeFrame': '4-5 years'}] | SecondaryOutcomes: N/A
Title: TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies | Condition: Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), NK-Cell Leukemia, Hodgkin Lymphoma, Non Hodgkin Lymphoma (NHL), Juvenile Myelomonocytic Leukemia (JMML), Chronic Myeloid Leukemia (CML) | Keywords: | Summary: | Description: In this study, participants with high-risk hematologic malignancies undergoing hematopoietic cell transplantation (HCT), who lack an available suitable human leukocyte antigen (HLA) matched related/sibling donor (MSD) or matched unrelated donor (MUD), will receive a TCRαβ-depleted haploidentical donor HCT with additional memory cell DLI. One course of blinatumomab will be empirically added for patients with CD19+ malignancy. Primary Objectives * Determine the maximum effective dose for prophylactic CD45RA-depleted DLI when given in the early post-engraftment period. * Assess the efficacy of TCRαβ-depleted progenitor cell graft with additional memory T-cell DLI, plus selected use of blinatumomab, in haploidentical donor hematopoietic cell transplantation for hematologic malignancies as measured by 1 year EFS (events = relapse, death) Secondary Objectives * Assess the safety and feasibility of the addition of blinatumomab in the early post- engraftment period in patients with CD19+ malignancy * Estimate the incidence of neutrophil and platelet engraftment, malignant relapse,event-free survival per disease subgroups (e.g. ALL vs AML), and overall survival at one-year post-transplantation. * Estimate incidence and severity of acute and chronic (GVHD). * Estimate the rate of transplant related mortality (TRM) in the first 100 days after transplantation. * To measure and describe the pharmacokinetics of rabbit ATG in HCT recipients on this study. Exploratory Objectives * Record immune reconstitution parameters, including chimerism analysis, quantitative lymphocyte subsets, T cell receptor excision circle (TREC) analysis, V-beta spectratyping, and lymphocyte phenotype and function. * Describe the use of additional CD45RA-depleted DLI for recipients who have severe viral infections, disease recurrence or progression, or poor immune reconstitution. Assess and record efficacy of CD45RA-depleted DLI for these conditions, and all adverse events that are related to CD45RA-depleted DLI. Blinatumomab will be given to patients with a history of CD19+ malignancy as determined by St. Jude hematopathologist review of current and historical specimens and reports. Blinatumomab dosing will begin no sooner than 1 week after CD45RA-depleted DLI and no later than Day +90. There must be no acute GVHD or it must be quiescent. ALT must be less than 5x ULN, bili less than or equal to 1.5x ULN, and creatinine less than or equal to 1.5x ULN. If more than one family member donor is suitable, then donor selection will be based on several factors including: degree of KIR mismatching, donor-recipient matching of CMV serology, donor-recipient red blood cell compatibility, degree of HLA matching, size of the potential donor, previous use as a donor, presence of donor-specific antibody, and overall health and availability of the potential donor. A G-CSF mobilized peripheral blood progenitor cell product (identified as HPC,A) is the preferred progenitor cell graft source. Our desired target goal will be 5 x 10\^6 CD34+ cells/kg. This number of cells will be necessary to provide an adequate graft, following the various ex vivo manipulations, for prompt reconstitution. More than one collection may be needed to achieve this goal. Donors will undergo a standard hematopoietic progenitor cell mobilization regimen consisting of 5 days of GSF given subcutaneously at 10 micrograms/kilogram. The graft will be collected by leukapheresis on day 5 (and 6 if needed) of G-CSF. The HPC product will typically be collected and infused fresh, however there may be patients or logistical situations that require the HPC product to be collected early, processed, and stored frozen. | ArmGroups: [{'label': 'Transplant participants', 'type': 'EXPERIMENTAL', 'description': 'Participants receive a conditioning regimen of ATG (rabbit),Cyclophosphamide 60 mg/kg intravenous once daily, mesna, fludarabine, thiotepa, melphalan, followed by HPC,A Infusion(TCRα/β+ and CD19+ depleted),HPC, A infusion (if needed to achieve goal CD34+ cell dose.CD45RA-depleted DLI will be given at least two weeks after engraftment. Blinatumomab will be given at least one week post-DLI, and only to patients with CD19+ malignancies. G-csf 5mcg/kg subcutaneous or intravenous daily until ANC \\>2000 for 2 consecutive days.\n\nCells for infusion are prepared using the CliniMACS system.', 'interventionNames': ['Drug: Cyclophosphamide', 'Biological: Fludarabine', 'Drug: Thiotepa', 'Drug: Melphalan', 'Biological: G-csf', 'Drug: Mesna', 'Device: CliniMACS', 'Biological: ATG (rabbit)', 'Drug: Blinatumomab', 'Biological: TCRα/β+', 'Biological: CD19+', 'Biological: CD45RA-depleted DLI']}] | Interventions:[{'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA.\n\nintravenously (IV) once daily (QD) on day -9', 'armGroupLabels': ['Transplant participants'], 'otherNames': ['Cytoxan']}, {'type': 'BIOLOGICAL', 'name': 'Fludarabine', 'description': 'Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis.\n\nfludarabine phosphate IV QD on days -8 to -4', 'armGroupLabels': ['Transplant participants'], 'otherNames': ['Fludara']}, {'type': 'DRUG', 'name': 'Thiotepa', 'description': 'Thiotepa is a cell-cycle nonspecific polyfunctional alkylating agent.', 'armGroupLabels': ['Transplant participants'], 'otherNames': ['Thioplex']}, {'type': 'DRUG', 'name': 'Melphalan', 'description': 'Melphalan, a derivative of nitrogen mustard, is a bifunctional alkylating agent. Melphalan is active against tumor cells that are actively dividing or at rest.\n\nmelphalan IV QD on days -2 to -1', 'armGroupLabels': ['Transplant participants'], 'otherNames': ['Alkeran']}, {'type': 'BIOLOGICAL', 'name': 'G-csf', 'description': 'G-csf (granulocytic colony stimulating factor), is a biosynthetic hematopoietic agent that is made using recombinant DNA technology in cultures of Escherichia coli. G-CSF stimulates production, maturation and activation of neutrophils. In addition, endogenous G-CSF enhances certain functions of mature neutrophils, including phagocytosis, chemotaxis and antibody--dependent cellular cytotoxicity.', 'armGroupLabels': ['Transplant participants'], 'otherNames': ['Neupogen', 'Filgrastim']}, {'type': 'DRUG', 'name': 'Mesna', 'description': 'Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide. Following glomerular filtration, mesna disulfide is rapidly reduced in the renal tubules back to mesna, the active form of the drug.', 'armGroupLabels': ['Transplant participants'], 'otherNames': ['Mesnex']}, {'type': 'DEVICE', 'name': 'CliniMACS', 'description': 'Cells for infusion are prepared using the CliniMACS', 'armGroupLabels': ['Transplant participants'], 'otherNames': ['CliniMACS Prodigy']}, {'type': 'BIOLOGICAL', 'name': 'ATG (rabbit)', 'description': 'Anti-thymocyte globulin is a purified, pasteurized, gamma immune globulin, obtained by immunization of rabbits with human thymocytes.\n\nrabbit anti-thymocyte globulin IV daily over 6 hours on days -5 to -3,', 'armGroupLabels': ['Transplant participants'], 'otherNames': ['Thymoglobulin']}, {'type': 'DRUG', 'name': 'Blinatumomab', 'description': 'Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that mediates formation of a synapse between T cells and the CD19+ target cell, resulting in lysis of that CD19+ cell.Blinatumomab will be given to patients with a history of CD19+ malignancy as determined by St. Jude hematopathologist review of current and historical specimens and reports.\n\nblinatumomab IV for 28 days beginning at least 1 week post-DLI', 'armGroupLabels': ['Transplant participants'], 'otherNames': ['Blincyto']}, {'type': 'BIOLOGICAL', 'name': 'TCRα/β+', 'description': 'IV on day 0 and may receive an additional dose on day 1', 'armGroupLabels': ['Transplant participants']}, {'type': 'BIOLOGICAL', 'name': 'CD19+', 'description': 'IV on day 0 and may receive an additional dose on day 1', 'armGroupLabels': ['Transplant participants']}, {'type': 'BIOLOGICAL', 'name': 'CD45RA-depleted DLI', 'description': 'infusion IV', 'armGroupLabels': ['Transplant participants']}] | PrimaryOutcomes: [{'measure': 'Maximum effective dose for prophylactic CD45RA-depleted DLI', 'description': 'Description: A maximum effective dose of CD45RA-depleted DLI is defined as the maximum value of doses that satisfy the proportion of patients with their memory T cell count measured at week 4 post-DLI more than 300/uL is more than 50% and the toxicity of grade 3-4 aGVHD is less than 20%.', 'timeFrame': '90 days after the transplant date of the last enrolled patient.'}, {'measure': 'One-year Event Free Survival (EFS) after completion of the protocol', 'description': 'Proportion of patients who are alive and relapse free one year after the date of transplant. (Events=relapse, death)', 'timeFrame': 'One year after the transplant date of the last enrolled patient'}] | SecondaryOutcomes: [{'measure': 'The number of patients experiencing Blinatumomab permanent discontinuation due to toxicity', 'description': 'If the drug is held for more than 2 weeks due to toxicity, it will be permanently discontinued', 'timeFrame': '120 days after transplant date of the last enrolled patient'}, {'measure': 'The estimate of cumulative incidence of relapse', 'description': 'The cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The Kaplan-Meier estimates of Overall Survival (OS) and Event Free Survival (EFS) along with their standard errors will be calculated. OS is defined as time from transplantation to death or last follow-up, whichever comes first. EFS is defined as time from transplantation to events including relapse, graft failure, death due to any cause and last follow-up, whichever comes first. The participants are alive at the time of analysis without events will be censored.', 'timeFrame': 'One year after the transplant date of the last enrolled patient'}, {'measure': 'The cumulative incidence of acute and chronic Graft-Versus-Host Disease (GVHD)', 'description': 'The cumulative incidence of acute and chronic (GVHD) will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of acute GVHD and chronic GVHD will be described.', 'timeFrame': 'One year after the transplant date of the last enrolled patient'}, {'measure': 'The cumulative incidence of transplant related mortality', 'description': 'The cumulative incidence of transplant related mortality will be estimated using Kalbfleisch-Prentice method. Death before day 100 of other reasons are the competing risk events.', 'timeFrame': '100 days after the transplant date of the last enrolled patient'}]
Title: A Phase II Trial Of STI571 For The Treatment Of Platinum And Taxane Refractory Stage III And IV Epithelial Ovarian Cancer And Primary Peritoneal Cancer | Condition: Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer | Keywords: | Summary: | Description: OBJECTIVES: I. Determine the response rates (confirmed, complete, and partial) in patients with platinum- and taxane-refractory stage III or IV ovarian epithelial or primary peritoneal cancer treated with imatinib mesylate. II. Determine the toxicity of this drug in these patients. III. Correlate, preliminarily, CD117 and platelet-derived growth factor receptor expression levels with response in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study. | ArmGroups: [{'label': 'Treatment (imatinib mesylate)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: imatinib mesylate', 'Other: laboratory biomarker analysis']}] | Interventions:[{'type': 'DRUG', 'name': 'imatinib mesylate', 'description': 'Given orally', 'armGroupLabels': ['Treatment (imatinib mesylate)'], 'otherNames': ['CGP 57148', 'Gleevec', 'Glivec']}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (imatinib mesylate)']}] | PrimaryOutcomes: [{'measure': 'Response rate (complete and partial confirmed response)', 'timeFrame': 'Up to 3 years'}] | SecondaryOutcomes: [{'measure': 'Toxicity as assessed by NCI Common Toxicity Criteria version 2.0', 'timeFrame': 'Up to 3 years'}]
Title: A Double-blind, Randomised, Multiple Dose, Phase III, Multicentre Study of Alpharadin in the Treatment of Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases | Condition: Hormone Refractory Prostate Cancer, Bone Metastases | Keywords: Hormone Refractory Prostate Cancer, Bone Metastases, Radium-223 | Summary: | Description: The aim of the study was to compare, in patients with symptomatic hormone refractory prostate cancer (HRPC) and skeletal metastases, the efficacy of best standard of care plus Radium-223 dichloride versus best standard of care plus placebo, with the primary efficacy endpoint being overall survival (OS). Patients were randomised in a 2:1 allocation ratio (Radium-223 dichloride:Placebo). The study treatment consisted of 6 intravenous administrations of Radium-223 dichloride or placebo (saline) each separated by an interval of 4 weeks. The patient were followed until 3 years after first study drug administration. Within the U.S., the trial was conducted under an IND sponsored by Bayer HealthCare Pharmaceuticals. All patients received BSoC (Best Standard of Care). This study has the original PCD as 14 October 2010, when a total of 316 deaths had been observed; this resulted in the Independent Data Monitoring Committee's (IDMC's) recommendation to stop the study as the primary efficacy analysis of overall survival had crossed the pre-specified boundary for efficacy. Later an updated analysis of primary endpoint in the first addendum was done with cut-off of 15 July 2011. | ArmGroups: [{'label': 'Radium-223 dichloride (Xofigo, BAY88-8223)', 'type': 'EXPERIMENTAL', 'description': 'Participants received radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus Best Standard of Care (BSoC).', 'interventionNames': ['Drug: Radium-223 dichloride (Xofigo, BAY88-8223)', 'Drug: Best standard of care (BSoC)']}, {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants received isotonic saline for 6 IV administrations separated by 4 weeks intervals plus Best Standard of Care (BSoC).', 'interventionNames': ['Drug: Placebo', 'Drug: Best standard of care (BSoC)']}] | Interventions:[{'type': 'DRUG', 'name': 'Radium-223 dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 dichloride 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals.', 'armGroupLabels': ['Radium-223 dichloride (Xofigo, BAY88-8223)'], 'otherNames': ['Alpharadin']}, {'type': 'DRUG', 'name': 'Placebo', 'description': 'Isotonic saline 6 IV administrations separated by 4 weeks intervals.', 'armGroupLabels': ['Placebo']}, {'type': 'DRUG', 'name': 'Best standard of care (BSoC)', 'description': 'Best standard of care is regarded as the routine standard of care at each center, for example local EBRT (External Beam Radiation Therapy), corticosteroids, antiandrogens, estrogens (e.g., stilboestrol), estramustine or ketoconazole.', 'armGroupLabels': ['Placebo', 'Radium-223 dichloride (Xofigo, BAY88-8223)']}] | PrimaryOutcomes: [{'measure': 'Overall Survival', 'description': 'Overall survival was defined as the time from date of randomization to the date of death.', 'timeFrame': 'From randomization to death due to any cause until approximately 3 years after start of enrollment, the data was collected up to the second data analysis date (15 JUL 2011)'}] | SecondaryOutcomes: [{'measure': 'Time to Total Alkaline Phosphatase (ALP) Progression', 'description': 'The time from the first study drug administration to when ALP progression was observed, defined as: 1) In subjects with no ALP decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial ALP decline from baseline; the time from start of treatment to first ALP increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later', 'timeFrame': 'From randomization to first ALP progression until approximately 3 years after start of enrollment'}, {'measure': 'Percentage of Participants With Total ALP Response at Week 12', 'description': "ALP levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed total ALP response (either \\>/= 30% or 50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.", 'timeFrame': 'At Baseline and Week 12'}, {'measure': 'Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)', 'description': "ALP levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed total ALP response (\\>/=50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.", 'timeFrame': 'At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)'}, {'measure': 'Percentage of Participants With Total ALP Normalization at Week 12', 'description': 'The return of total ALP value to within normal range at 12 weeks in 2 consecutive measurements (at least 2 weeks apart) after start of treatment in subjects who had ALP above the upper limit of normal (ULN) at baseline.', 'timeFrame': 'At Baseline and Week 12'}, {'measure': 'Percentage Change From Baseline in Total ALP at Week 12', 'description': "ALP level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (ALP level at week 12 minus ALP level at baseline)/(ALP level at baseline)\\*100", 'timeFrame': 'At Baseline and Week 12'}, {'measure': 'Maximum Percentage Decrease From Baseline in Total ALP up to Week 12', 'description': "ALP level was measured in participant's blood up to week 12 and the maximum percent decrease from the baseline up to Week 12 value was calculated as the minimum value of \\[(ALP level up to week 12 minus ALP level at baseline)/(ALP level at baseline)\\*100\\] by participant, and set to zero if no decrease from baseline.", 'timeFrame': 'From baseline to Week 12'}, {'measure': 'Percentage Change From Baseline in Total ALP at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)', 'description': "ALP level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (ALP level at EOT minus ALP level at baseline)/(ALP level at baseline)\\*100", 'timeFrame': 'At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)'}, {'measure': 'Maximum Percentage Decrease From Baseline in Total ALP During the 24 Week Treatment', 'description': "ALP level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 week treatment value was calculated as the minimum value of \\[(ALP level up to week 24 minus ALP level at baseline)/(ALP level at baseline)\\*100\\] by participant, and set to zero if no decrease from baseline.", 'timeFrame': 'From baseline During the 24 Week Treatment'}, {'measure': 'Time to Prostate Specific Antigen (PSA) Progression', 'description': 'The time from the first study drug administration to when PSA progression was observed, defined as: 1) In subjects with no PSA decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial PSA decline from baseline; the time from start of treatment to first PSA increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later', 'timeFrame': 'From randomization to first PSA progression until approximately 3 years after start of enrollment'}, {'measure': 'Percentage of Participants With PSA Response at Week 12', 'description': "PSA levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed PSA response (\\>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.", 'timeFrame': 'At Baseline and Week 12'}, {'measure': 'Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)', 'description': "PSA levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed PSA response (\\>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.", 'timeFrame': 'At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)'}, {'measure': 'Percentage Change From Baseline in PSA at Week 12', 'description': "PSA level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (PSA level at week 12 minus PSA level at baseline)/(PSA level at baseline)\\*100", 'timeFrame': 'At Baseline and Week 12'}, {'measure': 'Maximum Percentage Decrease From Baseline in PSA up to Week 12', 'description': "PSA level was measured in participant's blood up to Week 12 and the maximum percent decrease from the baseline up to week 12 value was calculated as the minimum value of \\[(PSA level up to week 12 minus PSA level at baseline)/(PSA level at baseline)\\*100\\] by participant, and set to zero if no decrease from baseline.", 'timeFrame': 'From baseline up to Week 12'}, {'measure': 'Percentage Change From Baseline in PSA at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)', 'description': "PSA level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (PSA level at EOT minus PSA level at baseline)/(PSA level at baseline)\\*100", 'timeFrame': 'At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)'}, {'measure': 'Maximum Percentage Decrease From Baseline in PSA Response During the 24 Week Treatment Period', 'description': "PSA level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 Week treatment value was calculated as the minimum value of \\[(PSA level up to week 24 minus PSA level at baseline)/(PSA level at baseline)\\*100\\] by participant, and set to zero if no decrease from baseline.", 'timeFrame': 'From baseline to End of Treatment (Week 24; 4 weeks post last injection)'}, {'measure': 'Time to First Skeletal Related Event (SRE)', 'description': 'A skeletal related event is the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumour related orthopaedic surgical intervention. For all other events, the start date of the event/medication/therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.', 'timeFrame': 'From randomization to first first SRE until approximately 3 years after start of enrollment'}, {'measure': 'Time to Occurrence of First Use of External Beam Radiation Therapy (EBRT) to Relieve Skeletal Symptoms', 'description': 'The start date of therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.', 'timeFrame': 'From randomization to first EBRT until approximately 3 years after start of enrollment'}, {'measure': 'Time to Occurrence of First Use of Radioisotopes to Relieve Skeletal Symptoms', 'description': 'The start date of the radioisotopes was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.', 'timeFrame': 'From randomization to first use of radioisotopes until approximately 3 years after start of enrollment'}, {'measure': 'Time to Occurrence of First New Symptomatic Pathological Bone Fractures, Vertebral and Non-vertebral', 'description': 'The start date of the event was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.', 'timeFrame': 'From randomization to occurrence of first new symptomatic pathological bone fractures until approximately 3 years after start of enrollment'}, {'measure': 'Time to Occurrence of First Tumor Related Orthopedic Surgical Intervention', 'description': 'The start date of the intervention was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.', 'timeFrame': 'From randomization to occurrence of first tumor related orthopedic surgical intervention until approximately 3 years after start of enrollment'}, {'measure': 'Time to Occurrence of First Spinal Cord Compression', 'description': 'The start date of the compression was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.', 'timeFrame': 'From randomization to first spinal cord compression until approximately 3 years after start of enrollment'}, {'measure': 'Time to Occurrence of First Start of Any Other Anti-cancer Treatment', 'description': 'The start date of the treatment was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.', 'timeFrame': 'From randomization to first start of any other anti-cancer treatment until approximately 3 years after start of enrollment'}, {'measure': 'Time to Occurrence of First Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least 2 Points From Baseline', 'description': 'ECOG scores were: 0 = fully active; 1 = restricted in physically strenuous activity; 2 = ambulatory and capable of all self-care but unable to work; 3 = capable of only limited self-care; 4 = completely disabled; 5 = death. The visit at which a 2-point or more deterioration in PS was observed was the time of the event. ECOG was assessed at every visit. If a marked deterioration in PS has not occurred at the time of the analysis or the participant was lost to follow-up, the time-to-event variables were censored at the last assessment date.', 'timeFrame': 'From randomization to first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) until approximately 3 years after start of enrollment'}]
Title: A Two-part, Phase I Open Label Dose-escalation Study to Assess the Safety, Pharmacokinetics and Clinical Activity of NUC-1031, a Nucleotide Analogue, in Patients With Advanced Solid Tumours. | Condition: Cancer | Keywords: cancer, nucleoside analogue, advanced solid tumours | Summary: | Description: This is a two-part, Phase I, open label study of NUC-1031 as a single agent, administered IV weekly on days 1, 8, \& 15 (Schedule A) or twice weekly on days 1 \& 5, 8 \& 12, 15 \&19 (Schedule B) of a 28 day- cycle regimen. An initial dose-escalation phase (Part I) will be followed by an expansion cohort phase (Part II) using the preferred regimen from Part I. In Part I, sequential patients will be assigned to increasing doses of NUC-1031 in a standard '3 + 3' design to determine the recommended Phase II dose (RP2D). There will be a review of all available data (in particular the safety profile and preliminary PK data through to at least the last scheduled day of Cycle 1) following enrolment of the second cohort of both schedule A and B to select the preferred administration schedule to take forward for ongoing evaluation. In Part II (dose expansion) additional patients will be enrolled to receive NUC-1031 at the RP2D and dosing frequency determined from Part I of the study. During Part II, further information will be obtained regarding safety, PK, PD and preliminary anti-tumour efficacy of NUC-1031 at RP2D. In both parts of the study, patients may continue to receive NUC-1031 for up to 6 cycles, until disease progression, for as long as the participant receives clinical benefit in the opinion of the CI, the occurrence of unmanageable drug related toxicity despite dose modification or if the study participant declines further treatment. | ArmGroups: [{'label': 'NUC-1031', 'type': 'EXPERIMENTAL', 'description': 'Cohort 1, Schedule A, NUC-1031 I.V. 1000mg/m2, Days 1, 8, \\& 15 every 28 days Cohort 1, Schedule B, NUC-1031 I.V. 500mg/m2, Days 1 \\& 5, 8 \\& 12, 15 \\&19 every 28 days Cohort 2, Schedule A, NUC-1031 I.V. 2000mg/m2, Days 1, 8, \\& 15 every 28 days Cohort 2, Schedule B, NUC-1031 I.V. 1000mg/m2, Days 1 \\& 5, 8 \\& 12, 15 \\&19 every 28 days', 'interventionNames': ['Drug: NUC-1031']}] | Interventions:[{'type': 'DRUG', 'name': 'NUC-1031', 'description': 'Cohort 1, Schedule A, NUC-1031 I.V. 1000mg/m2, Days 1, 8, \\& 15 every 28 days Cohort 1, Schedule B, NUC-1031 I.V. 500mg/m2, Days 1 \\& 5, 8 \\& 12, 15 \\&19 every 28 days Cohort 2, Schedule A, NUC-1031 I.V. 2000mg/m2, Days 1, 8, \\& 15 every 28 days Cohort 2, Schedule B, NUC-1031 I.V. 1000mg/m2, Days 1 \\& 5, 8 \\& 12, 15 \\&19 every 28 days', 'armGroupLabels': ['NUC-1031']}] | PrimaryOutcomes: [{'measure': 'To determine the RP2D of NUC-1031 administered as either an I.V. weekly or twice-weekly schedule in patients with advanced solid tumours.', 'description': 'Adverse events (AE) and changes from baseline in vital signs, clinical laboratory parameters, and electrocardiography (ECG) assessments will be assessed', 'timeFrame': '1.5 years'}, {'measure': 'To further evaluate the safety profile of NUC-1031 in an expanded cohort at RP2D', 'description': 'Adverse events (AE) and changes from baseline in vital signs, clinical laboratory parameters, and electrocardiography (ECG) assessments', 'timeFrame': '1 year'}] | SecondaryOutcomes: [{'measure': 'To determine the pharmacokinetics of NUC-1031 and its metabolites.', 'description': 'PK endpoints will include assessments such as systemic Clearance (CL), Apparent Volume of Distribution (Vd), Area Under the Curve (AUC), Maximum plasma (peak) drug concentration after single dose administration (Cmax), and t1/2.', 'timeFrame': '1.5 years'}, {'measure': 'To explore the preliminary anti-tumour activity of NUC-1031 [given at the RP2D and preferred schedule selected from Part I]', 'description': 'Assessment of anti-tumour activity as defined by RECIST version 1.1\n\nUrinary excretion of NUC-1031 and metabolites.', 'timeFrame': '1 year'}]
Title: Phase II Study of AZD9291 in Patients With Advanced Stage Non-small Cell Lung Cancer Following Prior EGFR TKI Therapy With EGFR and T790M Mutations Detected in Plasma Circulating Tumor DNA (PLASMA) | Condition: Carcinoma, Non-Small-Cell Lung | Keywords: | Summary: | Description: As T790M is the most common mechanism of acquired resistance to EGFR TKI, EGFR TKIs targeting T790M has been developed. AZD9291 is an oral, potent, irreversible EGFR-TKI selective for sensitizing (EGFRm) and T790M resistance mutation with a significant selectivity margin against wild-type EGFR. As a result, AZD9291 can effectively block EGFR signaling both in EGFR single mutant cells with activating EGFR mutations and in double mutant cells bearing the resistance T790M mutation. This is a prospective, open label, multi-centre single arm phase II study assessing the efficacy and safety of AZD9291 monotherapy in patients with stage IIIB or IV harboring sensitising EGFR mutation (exon 19 deletions and exon 21 L858R substitution mutations) and T790M who have progressed following prior treatment with an approved EGFR TKI. Approximately 108 subjects will be enrolled. All patients must have documented radiological progression on EGFR-TKI treatment and on the last treatment administered prior to enrolling in the study. Target patient population: Patients will be \> 18 years of age, with a diagnosis of locally advanced/metastatic NSCLC not amenable to curative surgery or radiotherapy with documented activating EGFR mutations (exon 19 deletions and exon 21 L858R substitution mutations) at the time of initial diagnosis, have radiological disease progression following either 1st line EGFR TKI treatment OR following prior therapy with an EGFR TKI and a platinum-based doublet chemotherapy. Plasma sample must harbour an EGFR mutation known to be associated with EGFR TKI sensitivity (exon 19 deletion, L858R as well as presence of T790M by central lab testing from a plasma sample taken after confirmation of disease progression on the most recent treatment regimen. Patients must have normal organ and bone marrow function and ECOG PS 0-2. Treatment and regimens: Patient will be treated with AZD9291 at a starting dose of 80mg once a day until the patient completes the study, withdraws from the study or closure of the study. A cycle of treatment is defined as 28 days of once daily AZD9291 treatment. Patients may continue to receive AZD9291 until objective disease progression (determined by RECIST 1.1) or if the subject is no longer receiving clinical benefit in the Investigator's opinion. | ArmGroups: [{'label': 'AZD9291', 'type': 'EXPERIMENTAL', 'description': "Patient will be treated with AZD9291 at a starting dose of 80mg once a day until the patient completes the study, withdraws from the study or closure of the study. A cycle of treatment is defined as 28 days of once daily AZD9291 treatment. Patients may continue to receive AZD9291 until objective disease progression (determined by RECIST 1.1) or if the subject is no longer receiving clinical benefit in the Investigator's opinion.", 'interventionNames': ['Drug: AZD9291']}] | Interventions:[{'type': 'DRUG', 'name': 'AZD9291', 'description': 'oral administration as a single daily dose of 80 mg', 'armGroupLabels': ['AZD9291'], 'otherNames': ['Osimertinib']}] | PrimaryOutcomes: [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'From the time of their first treatment with daily AZD9291 till 28 days after discontinuation'}] | SecondaryOutcomes: [{'measure': 'Progression free survival (PFS)', 'timeFrame': 'From the time of their first treatment with daily AZD9291 till 28 days after discontinuation'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'From the time of their first treatment with daily AZD9291 till 28 days after discontinuation'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'From the time of their first treatment with daily AZD9291 till 28 days after discontinuation'}, {'measure': 'Tumour shrinkage', 'timeFrame': 'From the time of their first treatment with daily AZD9291 till 28 days after discontinuation'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'From the time of their first treatment with daily AZD9291 till 28 days after discontinuation'}]
Title: Phase I Study of Intraperitoneal Carboplatin With Intravenous Paclitaxel and Bevacizumab in Patients With Previously Untreated Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma | Condition: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, No Prior Chemotherapy | Keywords: ovarian, cancer, fallopian tube, peritoneal, intraperitoneal, bevacizumab, carboplatin, paclitaxel, chemo-naive | Summary: | Description: Phase I study with the primary objective to determine the maximum tolerated dose of intraperitoneal carboplatin and intravenous weekly paclitaxel given in combination with intravenous bevacizumab during the second two cycles of treatment in patients with chemo-naive epithelial ovarian, primary peritoneal or fallopian tube cancer. The maximum tolerated dose is defined as the highest dose at which no more than 1 of 6 evaluable patients experiences a dose limiting toxicity during the second two cycles of treatment. Secondary objectives are to determine response rates and to estimate progression free survival and overall survival of this class of patients. | ArmGroups: [{'label': 'Carboplatin Paclitaxel & Bevacizumab', 'type': 'EXPERIMENTAL', 'description': 'Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Carboplatin', 'Drug: Bevacizumab']}] | Interventions:[{'type': 'DRUG', 'name': 'Paclitaxel', 'description': 'Cycle 1 Day 1, 8, 15 IV 60-80mg mg/m2 as a 1 hour infusion. For cycle 2-6 Day 1,8,15 IV 60-80 mg/m2 as 1 hour infusion. Repeat every 3 weeks times 5 cycles.', 'armGroupLabels': ['Carboplatin Paclitaxel & Bevacizumab'], 'otherNames': ['Abraxane', 'Taxol']}, {'type': 'DRUG', 'name': 'Carboplatin', 'description': 'Intraperitoneal Day 1 cycles 1-6 AUC', 'armGroupLabels': ['Carboplatin Paclitaxel & Bevacizumab'], 'otherNames': ['Paraplatin®']}, {'type': 'DRUG', 'name': 'Bevacizumab', 'description': 'Bevacizumab 15 mg/kg intravenous infusion Day 1 cycles 2-6 Optional cycles 7-22 15 mg/kg intravenous infusion Day 1 every 21 days', 'armGroupLabels': ['Carboplatin Paclitaxel & Bevacizumab'], 'otherNames': ['Avastin']}] | PrimaryOutcomes: [{'measure': 'Maximum Tolerated Dose', 'description': 'The Maximum Tolerated Dose is defined as the highest dose at which no more than 1 of 6 evaluable patients experiences a dose limiting toxicity.', 'timeFrame': 'Every Cycle-28 days'}] | SecondaryOutcomes: [{'measure': 'Response Rate, Progression Free Survival and Overall Survival', 'description': 'Response Rate in patients with measurable disease using the RECIST(Response Evaluation Criteria in Solid Tumors)criteria.\n\nProgression free survival is also uses the RECIST criteria or GCIG criteria. Overall survival will be followed for 5 years.', 'timeFrame': 'Every 3 monthes for 2 years, Every 6 months for 3 years.'}]
Title: An Open Label Phase II Trial to Assess the Efficacy and Safety of a Once Daily Oral Dose of 50 mg BIBW 2992 in Two Cohorts of Patients With HER2-negative Metastatic Breast Cancer After Failure of no More Than Two Chemotherapy Regimen | Condition: Breast Neoplasms | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'BIBW 2992', 'type': 'EXPERIMENTAL', 'description': 'high dose once daily', 'interventionNames': ['Drug: BIBW 2992']}] | Interventions:[{'type': 'DRUG', 'name': 'BIBW 2992', 'description': 'high dose once daily', 'armGroupLabels': ['BIBW 2992']}] | PrimaryOutcomes: [{'measure': 'Objective Response (OR)', 'description': 'OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.', 'timeFrame': 'Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.'}, {'measure': 'Clinical Benefit (CB)', 'description': 'CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A.', 'timeFrame': 'Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.'}] | SecondaryOutcomes: [{'measure': 'Clinical Benefit (CB)', 'description': 'CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A.', 'timeFrame': 'Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.'}, {'measure': 'Time to OR', 'description': 'The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.', 'timeFrame': 'Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.'}, {'measure': 'Duration of OR', 'description': 'Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.', 'timeFrame': 'Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.'}, {'measure': 'Progression-free Survival (PFS)', 'description': 'PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.', 'timeFrame': 'Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.'}, {'measure': 'Overall Survival (OS)', 'description': 'OS is defined as time from randomisation to death.', 'timeFrame': 'From randomisation to end of follow-up.'}, {'measure': 'Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)', 'description': 'LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan. MUGA scan is an useful noninvasive tool for assessing the function of the heart. Significant change in LVEF values was defined as \\>=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent.', 'timeFrame': 'Baseline and last assessment'}, {'measure': 'Best Change From Baseline in ECOG Performance Status', 'description': 'Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead).', 'timeFrame': 'baseline till end of treatment'}, {'measure': 'Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)', 'description': 'Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.', 'timeFrame': 'day 29'}]
Title: A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-004, a Humanized Monoclonal Antibody, in Subjects With Solid Tumors | Condition: Solid Tumor | Keywords: Solid Tumor, Endosialin | Summary: | Description: MORAb-004 is a monoclonal antibody directed against endosialin, a cell surface glycoprotein, which is expressed on cells involved in tumor vasculature. Studies have found endosialin to play a key role in tumor growth and neovessel formation in numerous cancer types including (but not limited to) renal, breast, colon, pancreatic, lung, endometrial, ovarian, melanoma, sarcoma, and neuroectodermal tumors. Preclinical pharmacological studies have shown that MORAb-004 is a potentially useful anti-cancer agent. This clinical trial is being performed to determine the safety of MORAb-004 in subjects with solid tumors, as well as to establish serum pharmacokinetics of the antibody, and to assess tumor antigens that may serve as predictors of a response to MORAb-004. Study Part 2 was added to enroll subjects with specific histological diagnoses (colorectal cancer and soft tissue sarcoma) to further characterize the safety and tolerability of 5 dose levels of MORAb-004 previously tested during the dose escalation in Part 1. | ArmGroups: [{'label': 'MORAb-004', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: MORAb-004 (monoclonal antibody to TEM1)']}] | Interventions:[{'type': 'DRUG', 'name': 'MORAb-004 (monoclonal antibody to TEM1)', 'description': 'Intravenous administration', 'armGroupLabels': ['MORAb-004']}] | PrimaryOutcomes: [{'measure': 'To determine the safety of multiple intravenous infusions of MORAb-004', 'description': 'Safety is evaluated by clinical assessment, monitoring of adverse events, laboratory evaluations, ECG.', 'timeFrame': 'Weekly while receiving study drug'}] | SecondaryOutcomes: [{'measure': 'To determine the maximum tolerated dose (MTD) of MORAb-004 (within the administered range)', 'description': 'Monitoring of adverse events, laboratory test results and ECG results.', 'timeFrame': 'Weekly'}, {'measure': 'To determine optimal biologic dose (OBD) of MORAb-004', 'description': 'Monitoring of adverse events, laboratory evaulations and ECG results.', 'timeFrame': 'Weekly'}, {'measure': 'To establish the serum pharmacokinetics of MORAb-004 using a validated assay', 'description': 'Serial serum PK evaluations.', 'timeFrame': 'Weekly'}, {'measure': 'To describe changes in the objective measurements of tumor size and biomarkers (if applicable)after treatment with MORAb-004', 'description': 'CT or MRI evaluations following every other 4-week cycle.', 'timeFrame': 'bimonthly'}, {'measure': 'To detect any antibody response (human anti-human antibodies [HAHA] to multiple intravenous infusions of MORAb-004', 'description': 'Biweekly serum collection for detection of HAHA during treatment.', 'timeFrame': 'Biweekly'}]
Title: Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in High-Risk Patients With Early-Stage Cervical Carcinoma Following Radical Hysterectomy | Condition: Cervical Cancer | Keywords: cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, stage IA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer | Summary: | Description: OBJECTIVES: Primary * To determine if administering adjuvant systemic chemotherapy after chemoradiotherapy will improve disease-free survival compared to chemoradiotherapy alone in patients with high-risk early-stage cervical carcinoma found to have positive nodes and/or positive parametria after radical hysterectomy. Secondary * To evaluate adverse events. * To evaluate overall survival. * To evaluate quality of life. * To evaluate chemotherapy-induced neuropathy. * To perform a post-hoc dose-volume evaluation between patients treated with standard radiotherapy and patients treated with intensity-modulated radiotherapy (IMRT) with respect to toxicity and local control. * To collect fixed tissue samples to identify tumor molecular signatures that may be associated with patient outcomes, such as adverse events, disease-free survival, and overall survival. * To collect blood samples to identify secreted factors from serum and plasma that may be associated with adverse events or outcome and to identify single nucleotide polymorphisms (SNPs) in genes from buffy coat that may be associated with a genetic predisposition to tumor formation itself or a response to cytotoxic therapy. OUTLINE: This is a multicenter study. Patients are stratified according to planned use of brachytherapy (no vs. yes), radiotherapy modality - \[standard external beam radiotherapy (EBRT) vs. intensity-modulated radiotherapy (IMRT)\], and radiotherapy dose (45 Gy vs. 50.4 Gy). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo standard EBRT or IMRT to the pelvis once daily 5 days a week for 5-6 weeks. Patients also receive concurrent cisplatin IV over 1 hour once weekly for 6 weeks. NOTE: Some patients may also undergo brachytherapy beginning within 7 days after completion of radiotherapy. * Arm II: Patients receive chemoradiotherapy as in arm I. Beginning 4-6 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed by the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group (FACT-GOG/NTX4), FACT-Cx, and FACIT-D questionnaires at baseline; at the completion of chemoradiotherapy; and then at 6, 12, and 24 months after completion of chemoradiotherapy. Blood and tissue samples may be collected for gene expression analysis by immuno-histochemistry (IHC) and for biomarker and polymorphism studies. After completion of study treatment, patients are followed up very 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. | ArmGroups: [{'label': 'Arm I: Cisplatin/Radiation Therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m\\^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional.', 'interventionNames': ['Drug: cisplatin', 'Radiation: intensity-modulated radiation therapy', 'Radiation: standard external beam radiation therapy', 'Radiation: Optional brachytherapy boost']}, {'label': 'Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel', 'type': 'EXPERIMENTAL', 'description': 'Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV \\[135 mg/m2, with maximum body surface area (BSA) of 2.0 m\\^2 over 3 hours\\] and carboplatin IV \\[area under the curve (AUC) 5 over 30 minutes\\] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: carboplatin', 'Drug: cisplatin', 'Drug: paclitaxel', 'Radiation: intensity-modulated radiation therapy', 'Radiation: standard external beam radiation therapy', 'Radiation: Optional brachytherapy boost']}] | Interventions:[{'type': 'DRUG', 'name': 'carboplatin', 'description': 'Intravenously', 'armGroupLabels': ['Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel']}, {'type': 'DRUG', 'name': 'cisplatin', 'description': 'Intravenously', 'armGroupLabels': ['Arm I: Cisplatin/Radiation Therapy', 'Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel']}, {'type': 'DRUG', 'name': 'paclitaxel', 'description': 'Intravenously', 'armGroupLabels': ['Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel']}, {'type': 'RADIATION', 'name': 'intensity-modulated radiation therapy', 'description': 'Daily fractions', 'armGroupLabels': ['Arm I: Cisplatin/Radiation Therapy', 'Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel'], 'otherNames': ['IMRT']}, {'type': 'RADIATION', 'name': 'standard external beam radiation therapy', 'description': 'Daily fractions', 'armGroupLabels': ['Arm I: Cisplatin/Radiation Therapy', 'Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel'], 'otherNames': ['EBRT']}, {'type': 'RADIATION', 'name': 'Optional brachytherapy boost', 'description': 'Low-dose rate (20-25 Gy single application) or high-dose rate (12-18 Gy 2-3 applications), dependent on external beam dose.', 'armGroupLabels': ['Arm I: Cisplatin/Radiation Therapy', 'Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel']}] | PrimaryOutcomes: [{'measure': 'Disease-free Survival (Percentage of Participants Alive Without Disease)', 'description': 'Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants.', 'timeFrame': 'From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported.'}] | SecondaryOutcomes: [{'measure': 'Overall Survival (Percentage of Participants Alive)', 'description': 'Overall survival is estimated by the Kaplan-Meier method. The distribution of survival estimates between the two arms is compared using the log rank test. Survival time is measured from the date of randomization to the date of death from any cause or last known follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants.', 'timeFrame': 'From randomization to death or last follow-up. Maximum follow-up time at time of analysis was 12.8 years. The 2- and 4-year survival estimates are reported.'}, {'measure': 'Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) at 12 Months', 'description': 'The FACT-GOG/NTX4 measures patient-reported symptoms of chemotherapy-induced peripheral neuropathy in cancer patients. Possible scores range from 0 to 16 with higher scores indicating a better condition. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms.', 'timeFrame': 'Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks)'}, {'measure': 'Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) Diarrhea Subscore at 12 Months', 'description': 'The diarrhea-specific subscore of the FACIT-D measures patient-reported diarrhea symptoms. Possible scores range from 0 to 44 with higher scores indicating a better quality of life. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms.', 'timeFrame': 'Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks)'}, {'measure': 'Functional Assessment of Cancer Therapy - Cervix (FACT-Cx) Cervical Cancer Subscore at 12 Months', 'description': 'The cervical cancer subscore of the FACT-Cx measures patient-reported symptoms and problems related to cervical cancer. Possible scores range from 0 to 60 with higher scores indicating a better quality of life. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms.', 'timeFrame': 'Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks)'}, {'measure': 'Number of Participants by Highest Grade Adverse Event Reported', 'description': 'Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.', 'timeFrame': 'From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.'}, {'measure': 'Associations Between Tumor Molecular Signatures, From Fixed Tissue, and Outcomes Such as Adverse Events, Disease Free Survival and Overall Survival', 'timeFrame': 'From randomization to last follow-up'}, {'measure': 'Associations Between Secreted Factors From Serum and Plasma With Adverse Events or Outcome', 'timeFrame': 'From randomization to last follow-up.'}, {'measure': 'Associations Between Single Nucleotide Polymorphisms (SNPs) in Genes From Buffy Coat and a Genetic Predisposition to Tumor Formation Itself or a Response to Cytotoxic Therapy', 'timeFrame': 'From randomization to last follow-up.'}]
Title: A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer | Condition: Breast Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'SHR-A1811', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: SHR-A1811']}, {'label': "Physician's Choice", 'type': 'ACTIVE_COMPARATOR', 'description': 'Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel', 'interventionNames': ['Drug: Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel']}] | Interventions:[{'type': 'DRUG', 'name': 'SHR-A1811', 'description': "SHR-A1811 is a lyophilized powder for injection intravenously. Administered according to label, as one option for Physician's Choice.", 'armGroupLabels': ['SHR-A1811']}, {'type': 'DRUG', 'name': 'Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel', 'description': "Administered according to label, as one option for Physician's Choice (determined before randomization).", 'armGroupLabels': ["Physician's Choice"]}] | PrimaryOutcomes: [{'measure': 'Progression-free Survival (PFS) Based on Blind Independent Video Review Committee (BIRC)', 'timeFrame': 'within approximately 2 years'}] | SecondaryOutcomes: [{'measure': 'Overall Survival (OS)', 'description': 'Time from the date of randomization to the date of death for any cause. If there is no death reported for a participant before the data cutoff for OS analysis, OS will be censored at the last contact date at which the participant is known to be alive.', 'timeFrame': 'within approximately 3 years'}, {'measure': 'Objective Response Rate (ORR)', 'description': 'Percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR), confirmed by a second assessment.', 'timeFrame': 'within approximately 2 years'}, {'measure': 'Duration of Response (DoR)', 'description': 'DoR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.', 'timeFrame': 'within approximately 2 years'}, {'measure': 'Clinical Benefit Rate (CBR)', 'description': 'CBR is defined as complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.', 'timeFrame': 'within approximately 2 years'}]
Title: A Multi-Center Trial of Androgen Suppression With Abiraterone aCetate, LEuprolide, PARP Inhibition and Stereotactic Body Radiotherapy (ASCLEPIuS): A Phase I/2 Trial in High Risk and Node Positive Prostate Cancer | Condition: Prostate Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Niraparid Dose Escalation', 'type': 'EXPERIMENTAL', 'description': 'Dose Level 1: 100 mg PO daily of Niraparib but held for 5 days (+/- 2 days) prior to RT, during SBRT, and 5 days (+/- 2 days) after last fraction of SBRT\n\nDose Level 2: 200 mg PO daily of Niraparib but held for 5 days (+/- 2 days) prior to RT, during SBRT, and 5 days (+/- 2 days) after last fraction of SBRT\n\nDose Level 3: 200 mg PO daily of Niraparib without breaks during SBRT until completion of 6 cycles.', 'interventionNames': ['Drug: Niraparib', 'Drug: Leuprolide', 'Drug: Abiraterone Acetate', 'Radiation: Stereotactic body radiotherapy (SBRT)']}] | Interventions:[{'type': 'DRUG', 'name': 'Niraparib', 'description': 'given PO per dose escalation schedule', 'armGroupLabels': ['Niraparid Dose Escalation']}, {'type': 'DRUG', 'name': 'Leuprolide', 'description': '22.5 mg q3 month', 'armGroupLabels': ['Niraparid Dose Escalation']}, {'type': 'DRUG', 'name': 'Abiraterone Acetate', 'description': '1000 mg daily', 'armGroupLabels': ['Niraparid Dose Escalation']}, {'type': 'RADIATION', 'name': 'Stereotactic body radiotherapy (SBRT)', 'description': '5-6 fraction SBRT (total dose: 37.5-40 Gy)', 'armGroupLabels': ['Niraparid Dose Escalation'], 'otherNames': ['Ultra-hypofractionated radiotherapy']}] | PrimaryOutcomes: [{'measure': 'Dose-limiting toxicities (Phase 1)', 'description': "The proportion of patients at each dose level with dose-limiting toxicity (DLT), defined as any treatment related grade 3-5 adverse event experienced within the first 4 treatment cycles (112 days), assessed per NCI's CTCAE version 5.0.", 'timeFrame': 'Up to 112 days after initial dose of niraparib'}, {'measure': 'Proportion of patients experiencing biochemical failure', 'description': 'Change in PSA level from the beginning of study treatment for up to 3 years later will determine the biochemical failure rate. Biochemical failure will be defined using the Phoenix definition of the PSA nadir + 2 ng/mL.', 'timeFrame': 'Up to 3 years after first dose of niraparib'}] | SecondaryOutcomes: [{'measure': 'Change in health related quality of life', 'description': 'Assessed via EPIC-26 questionnaire', 'timeFrame': 'From baseline up to 3 years after last dose of niraparib'}, {'measure': 'Proportion of patients with undetectable post-treatment PSA', 'description': 'Undetectable PSA will be defined as a PSA ≤0.1 ng/mL.', 'timeFrame': 'Measured during the end of the 6th cycle of therapy (during week 24 +/- 7 days)'}, {'measure': 'Proportion of patients with distant metastases', 'description': 'Distant metastases will be defined as any clinical or radiographic evidence of lymph node, bone, or visceral involvement of prostate cancer.', 'timeFrame': 'Up to 5 years after first dose of niraparib'}, {'measure': 'Prostate cancer specific survival', 'description': 'Prostate cancer specific survival will be defined as the duration of time from the start of treatment to death attributable to prostate cancer. Patients who have not died or die of non-prostate cancer related causes will be censored at the last known follow-up or date of death, respectively. Summarized using cumulative incidence or Kaplan-Meier curves as appropriate.', 'timeFrame': 'Up to 5 years after first dose of niraparib'}, {'measure': 'Overall survival', 'description': 'Overall survival (OS) will be defined as the duration of time from the start of treatment to death from any cause. Patients who have not died will be censored at the last known follow-up.Summarized using cumulative incidence or Kaplan-Meier curves as appropriate.', 'timeFrame': 'Up to 5 years after first dose of niraparib'}]
Title: Epidemiology and Outcome of Solitary Fibrous Tumors of the Pleura. A Multicenter Study. | Condition: Solitary Fibrous Tumors of the Pleura | Keywords: | Summary: | Description: Retrospective observational study on patients with SFPT in the German spoken part of Switzerland between 2000 and 2011 (approximately 300 patients): Phase 1) Information leaflet (letter of invitation) from study center (University Hospital of Zurich) to the institutes for pathology from all university, cantonal and city hospitals in the German spoken part of Switzerland. Patient recruitment performed by medical staff from the aforementioned institutes for pathology. Phase 2) Obtaining first orally (by telephone) and thereafter written informed consent from the patients performed by medical staff from the aforementioned institutes for pathology. Phase 3) After written and oral consent has been given, a doctoral candidate (member of the study group, student of the University of Zurich) will perform the data entry based on clinical and histological records locally at each external institute for pathology (no patient record files will be copied or transferred in original to the University Hospital of Zurich). Data entry in the electronic case report from (excel file on study laptop) will be performed with anonymous data only. Hence, each patient will have a study number containing the treating hospital, year of diagnosis and a consecutive number (e.g. KSSG-2011-1, KSSG-2011-2, STZ-2007-1, STZ-2007-2, ...). No names or birth dates will appear in the case report form. Provided that informed consent is given, patient follow-up will be performed by contacting the primary care physician (general physician or family doctor) by telephone, which is handled by the doctoral candidate. Deceased patients will not be incorporated within the study. Phase 4) Review of the histological specimen which are collected by the aforementioned doctoral candidate and brought to the University Hospital of Zurich, Institute for Pathology, where immunohistochemical/molecular examinations, such as immunostaining, fluorescence in situ hybridization (FISH) and mutational analysis of the histological specimen are performed by PD Dr. A. Soltermann, member of the study team. After this, the specimens are returned to the original institute for pathology, where they were taken. All specimens are made anonymous at the moment of collection at the external hospital by the doctoral candidate (each specimen is labeled with the aforementioned study number, which is assigned in the case report form). Phase 5) Data analysis, publication. | ArmGroups: N/A | Interventions:N/A | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A
Title: Traditional Chinese Medicine as Preventive Method for Osteoporosis in Early Breast Cancer Patients Receiving Adjuvant Endocrine Therapy | Condition: Breast Cancer, Osteoporosis | Keywords: Chinese Traditional Medicine, Osteoporosis, adjuvant endocrine therapy, early breast cancer | Summary: | Description: Breast cancer is the most common malignant tumor in female wolrdwide. Results from clinical trials like ATAC trial have demonstrated the efficacy of AIs in postmenopausal breast cancer patients. Meanwhile it may cause a certain rate of osteoporosis in postmenopausal patients. The aim of this trial is to test the efficacy of two traditional Chinese medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy. | ArmGroups: [{'label': 'Letrozole', 'type': 'PLACEBO_COMPARATOR', 'description': 'Early Breast Cancer patients receiving adjuvant endocrine therapy\n\nAdjuvant Endocrine Therapy: letrozole 2.5 mg qd po.', 'interventionNames': ['Drug: Letrozole']}, {'label': 'Letrozole + Xinglinggubao', 'type': 'ACTIVE_COMPARATOR', 'description': 'Early Breast Cancer patients receiving adjuvant endocrine therapy plus Xianlinggubao\n\nAdjuvant Endocrine Therapy: letrozole 2.5 mg qd po.\n\nXinglinggubao: 0.5g bid po', 'interventionNames': ['Drug: Letrozole', 'Drug: Xianlinggubao']}, {'label': 'Letrozole + Zhongyaofufang', 'type': 'ACTIVE_COMPARATOR', 'description': 'Early Breast Cancer patients receiving adjuvant endocrine therapyplus Zhongyaofufang (Traditional Chinses Medicine)\n\nAdjuvant Endocrine Therapy: letrozole 2.5 mg qd po.\n\nZhongyaofufang: qow po', 'interventionNames': ['Drug: Letrozole', 'Drug: Zhongyaofufang']}] | Interventions:[{'type': 'DRUG', 'name': 'Letrozole', 'description': 'Letrozole endocrine therapy for 2.5mg qd po.', 'armGroupLabels': ['Letrozole', 'Letrozole + Xinglinggubao', 'Letrozole + Zhongyaofufang'], 'otherNames': ['L']}, {'type': 'DRUG', 'name': 'Zhongyaofufang', 'description': 'Traditional Chinese Medicine for patients with Osteoporosis', 'armGroupLabels': ['Letrozole + Zhongyaofufang'], 'otherNames': ['Z']}, {'type': 'DRUG', 'name': 'Xianlinggubao', 'description': 'Traditional Chinese Medicine for patients with Osteoporosis', 'armGroupLabels': ['Letrozole + Xinglinggubao'], 'otherNames': ['X']}] | PrimaryOutcomes: [{'measure': 'Change of Bone Mineral Density', 'description': 'The change of bone mineral density of the L2-L4 region of the spine and hip between pre- and post-endocrine therapy for one year', 'timeFrame': '1 year'}] | SecondaryOutcomes: [{'measure': 'Bone Frature Rate', 'description': 'the rate of bone fracture in patient receiving endocrine therapy', 'timeFrame': '1 year'}, {'measure': 'Bone Metabolism', 'description': 'The change of bone metabolism assessed by the scale of serum bone alkaline phosphatase, serum C-telopeptide and urineN-telopeptide between pre- and post-endocrine therapy for one year', 'timeFrame': '1 year'}, {'measure': 'Disease Free Survival', 'description': 'the rate of patients without disease', 'timeFrame': '1 year'}]
Title: A Phase Ib/II Platform Trial of Newly Emerging Immunotherapy for Pancreatic Cancer Treatment | Condition: Pancreatic Cancer | Keywords: | Summary: | Description: The cohort A/B/C included patients with unresectable locally advanced or metastatic pancreatic cancer who had previously failed at least first line gemcitabine-based system therapy.The cohort D/E/F included patients with previously untreated systemic pancreatic cancer with unresectable locally advanced or metastatic pancreatic cancer.This study plans to first explore A/B/C cohort, and then start the D/E/F cohort after determining the safety. | ArmGroups: [{'label': 'Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV)', 'type': 'EXPERIMENTAL', 'description': 'Participants with unresectable locally advanced or metastatic pancreatic cancer who had previously failed at least first line gemcitabine-based system therapy will receive JS004 and JS001 combined with chemotherapy (irinotecan liposome injection+5-FU/LV) until the treatment termination event specified in the protocol occurs.', 'interventionNames': ['Drug: JS001', 'Drug: JS004', 'Drug: Irinotecan Liposome Injection', 'Drug: 5-Fluorouracil (5-FU)', 'Drug: Leucovorin (LV)']}, {'label': 'Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV', 'type': 'EXPERIMENTAL', 'description': 'Participants with unresectable locally advanced or metastatic pancreatic cancer who had previously failed at least first line gemcitabine-based system therapy will receive JS007 and JS001 combined with chemotherapy (irinotecan liposome injection+5-FU/LV) until the treatment termination event specified in the protocol occurs.', 'interventionNames': ['Drug: JS001', 'Drug: JS007', 'Drug: Irinotecan Liposome Injection', 'Drug: 5-Fluorouracil (5-FU)', 'Drug: Leucovorin (LV)']}, {'label': 'Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV', 'type': 'EXPERIMENTAL', 'description': 'Participants with unresectable locally advanced or metastatic pancreatic cancer who had previously failed at least first line gemcitabine-based system therapy will receive JS015 and JS001 combined with chemotherapy (irinotecan liposome injection+5-FU/LV) until the treatment termination event specified in the protocol occurs.', 'interventionNames': ['Drug: JS001', 'Drug: JS015', 'Drug: Irinotecan Liposome Injection', 'Drug: 5-Fluorouracil (5-FU)', 'Drug: Leucovorin (LV)']}, {'label': 'Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine', 'type': 'EXPERIMENTAL', 'description': 'Participants with previously untreated systemic pancreatic cancer with unresectable locally advanced or metastatic pancreatic cancer will receive JS004 and JS001 combined with chemotherapy (nab-paclitaxel+gemcitabine) until the treatment termination event specified in the protocol occurs.', 'interventionNames': ['Drug: JS001', 'Drug: JS004', 'Drug: Nab paclitaxel', 'Drug: Gemcitabine']}, {'label': 'Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine', 'type': 'EXPERIMENTAL', 'description': 'Participants with previously untreated systemic pancreatic cancer with unresectable locally advanced or metastatic pancreatic cancer will receive JS007 and JS001 combined with chemotherapy (nab-paclitaxel+gemcitabine) until the treatment termination event specified in the protocol occurs.', 'interventionNames': ['Drug: JS001', 'Drug: JS007', 'Drug: Nab paclitaxel', 'Drug: Gemcitabine']}, {'label': 'Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine', 'type': 'EXPERIMENTAL', 'description': 'Participants with previously untreated systemic pancreatic cancer with unresectable locally advanced or metastatic pancreatic cancer will receive JS015 and JS001 combined with chemotherapy (nab-paclitaxel+gemcitabine) until the treatment termination event specified in the protocol occurs.', 'interventionNames': ['Drug: JS001', 'Drug: JS015', 'Drug: Nab paclitaxel', 'Drug: Gemcitabine']}] | Interventions:[{'type': 'DRUG', 'name': 'JS001', 'description': '240 mg by IV infusionevery 3 weeks (Q3W), given on cycle day 1.', 'armGroupLabels': ['Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV)', 'Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV', 'Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV', 'Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine', 'Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine', 'Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine'], 'otherNames': ['Toripalimab']}, {'type': 'DRUG', 'name': 'JS004', 'description': '200 mg by IV infusion Q3W, given on cycle day 1.', 'armGroupLabels': ['Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV)', 'Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine']}, {'type': 'DRUG', 'name': 'JS007', 'description': '3mg/kg by IV infusion Q3W, given on cycle day 1.', 'armGroupLabels': ['Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV', 'Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine']}, {'type': 'DRUG', 'name': 'JS015', 'description': '600mg by IV infusion Q3W, given on cycle day 1.', 'armGroupLabels': ['Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV', 'Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine']}, {'type': 'DRUG', 'name': 'Irinotecan Liposome Injection', 'description': '60 or 70 mg/m\\^2 by IV infusion every 2 weeks (Q2W), given on cycle day 1.', 'armGroupLabels': ['Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV)', 'Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV', 'Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV']}, {'type': 'DRUG', 'name': '5-Fluorouracil (5-FU)', 'description': '2400mg/m\\^2, intravenously, over 46 h on day 1, Q2W.', 'armGroupLabels': ['Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV)', 'Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV', 'Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV']}, {'type': 'DRUG', 'name': 'Leucovorin (LV)', 'description': '400mg/m\\^2, intravenously, over 30 min on day 1, Q2W.', 'armGroupLabels': ['Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV)', 'Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV', 'Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV']}, {'type': 'DRUG', 'name': 'Nab paclitaxel', 'description': '125 mg/m\\^2 by IV infusion Q3W, given on cycle day 1 and 8.', 'armGroupLabels': ['Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine', 'Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine', 'Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine']}, {'type': 'DRUG', 'name': 'Gemcitabine', 'description': '1000 mg/m\\^2 by IV infusion Q3W, given on cycle day 1 and 8.', 'armGroupLabels': ['Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine', 'Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine', 'Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine']}] | PrimaryOutcomes: [{'measure': 'Incidence of dose-limiting toxicity (DLT) (phase IB)', 'description': 'If less than 2 participants developed DLT during the safety observation period (one cycle after the first dose), follow-up first-line D/E/F cohort exploration should be considered. Otherwise, it is up to the investigator to decide the next research plan.', 'timeFrame': '21 days after the first dose was administered to each subject'}, {'measure': 'Objective Response Rate (ORR) (phase II)', 'description': 'ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1.', 'timeFrame': 'Up to 1 year'}] | SecondaryOutcomes: [{'measure': 'Objective Response Rate (ORR) (phase IB)', 'description': 'ORR was defined as the percentage of participants with a best overall response of CR or PR based on RECIST 1.1.', 'timeFrame': 'Up to 1 year'}, {'measure': 'Disease control rate (DCR)', 'description': 'DCR was defined as the percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable based on RECIST 1.1.', 'timeFrame': 'Up to 1 year'}, {'measure': 'Duration of Response (DOR)', 'description': 'DOR will be calculated from the date of the first evaluation showing PR, or CR, to the date of the first disease progression or death, whichever comes first and based on RECIST 1.1.', 'timeFrame': 'Up to 1 year'}, {'measure': 'Progression free survival (PFS)', 'description': 'PFS is defined as the time from the first dose until objective tumor progression(PD), or death, whichever comes first and based on RECIST 1.1. At the end of the study, the time of last acquisition of living patients without PD was taken as the deleted data.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Overall Survival (OS)', 'description': 'OS will be measured from the date of first dose to death from any cause.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment', 'description': 'Adverse event (AE), abnormal laboratory examination, serious adverse event (SAE) related with the study drug judged using NCI-CTCAE V5.0 by investigator.', 'timeFrame': '90 days after the last administration'}]
Title: A Clinical Study for the Evaluation of the Association Between CYP2D6 Genetic Polymorphisms and the Treatment Effect of Tamoxifen in Patients With Metastatic Breast Cancer | Condition: Breast Cancer, Metastatic Disease | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'tamoxifen', 'type': 'OTHER', 'description': 'observation for clinical efficacy on tamoxifen according to CYP2D6 genotype', 'interventionNames': ['Drug: Tamoxifen']}] | Interventions:[{'type': 'DRUG', 'name': 'Tamoxifen', 'description': 'tamoxifen 20mg, PO, QD until disease progression', 'armGroupLabels': ['tamoxifen']}] | PrimaryOutcomes: [{'measure': 'efficacy of tamoxifen', 'timeFrame': 'one year'}] | SecondaryOutcomes: N/A
Title: The Effect of Perceived Injustice Targeted Pain Neuroscience Education and Motivational Interviewing Compared to Biomedical Focused Education in Breast Cancer Survivors | Condition: Breast Neoplasms, Survivorship, Pain, Chronic | Keywords: Breast cancer survivor, Perceived injustice, Pain Neuroscience Education, Motivational Interviewing, Biomedical Education | Summary: | Description: N/A | ArmGroups: [{'label': 'Pain Neuroscience Education (PNE) + Motivational Interviewing (MI)', 'type': 'EXPERIMENTAL', 'description': "Breast cancer survivors assigned to the experimental intervention will participate in 1 online PNE session followed by 3 PNE + MI sessions spread over 4 weeks. Each session will last for approximately 45 minutes and all sessions will be held in one-on-one format, allowing to individually tailor content to the patient's maladaptive beliefs and perceived injustice. After the first live session, breast cancer survivors will receive a perceived injustice-targeted PNE information leaflet that they need to read carefully at home.", 'interventionNames': ['Behavioral: Pain Neuroscience Education (PNE)', 'Behavioral: Motivational Interviewing (MI)']}, {'label': 'Biomedically-focused Education', 'type': 'ACTIVE_COMPARATOR', 'description': "Breast cancer survivors assigned to the experimental intervention will participate in 1 online biomedically-focused education session followed by 3 biomedically-focused education sessions spread over 4 weeks. Each session will last for approximately 45 minutes and all sessions will be held in one-on-one format in order to balance nonspecific treatment effects between treatment arms, the duration, format and number of sessions as well as the didactical approach will be identical in both treatment groups. After the first live session, breast cancer survivors will receive an information leaflet from 'Kom op tegen Kanker' regarding 'Pain in and after treatment' that they need to read carefully at home.", 'interventionNames': ['Behavioral: Biomedically-focused education']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Pain Neuroscience Education (PNE)', 'description': 'PNE is a cognitive behavioural intervention, including educating patients that pain is an output product of the brain resulting from input from multiple central and peripheral nervous system processes and leading to threat perception. Transferring that knowledge to patients, allows them to understand, accept and effectively cope with their pain. In order to obtain the targeted behavioural change, motivational interviewing is used as the communication process throughout PNE.', 'armGroupLabels': ['Pain Neuroscience Education (PNE) + Motivational Interviewing (MI)']}, {'type': 'BEHAVIORAL', 'name': 'Motivational Interviewing (MI)', 'description': 'Motivational interviewing is a directive, collaborative, patient-centered communication approach for eliciting and enhancing motivation for behaviour change by helping clients to resolve ambivalence and uncertainty.', 'armGroupLabels': ['Pain Neuroscience Education (PNE) + Motivational Interviewing (MI)']}, {'type': 'BEHAVIORAL', 'name': 'Biomedically-focused education', 'description': "The traditional biomedical-focused education programme explains patient's pain experience from a tissue (injured versus healthy tissue) and biomechanical perspective.", 'armGroupLabels': ['Biomedically-focused Education']}] | PrimaryOutcomes: [{'measure': 'Pain Outcome', 'description': "The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score \\> 0.80).", 'timeFrame': 'T0: within the week before the randomisation and the start of the intervention'}, {'measure': 'Pain Outcome', 'description': "The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score \\> 0.80).", 'timeFrame': 'T1: immediately after completing intervention'}, {'measure': 'Pain Outcome', 'description': "The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score \\> 0.80).", 'timeFrame': 'T2: 6 months after therapy completion'}, {'measure': 'Pain Outcome', 'description': "The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score \\> 0.80).", 'timeFrame': 'T3: 12 months after therapy completion'}, {'measure': 'Pain Outcome', 'description': "The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score \\> 0.80).", 'timeFrame': 'T4: 24 months after therapy completion'}] | SecondaryOutcomes: [{'measure': 'Health-related quality of life (HR-QoL)', 'description': "The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a 30-item cancer-specific questionnaire developed for the assessment of quality of life in cancer patients. The EORTC QLQ-C30 is widely used in cancer studies, has been translated and validated in over 100 languages and shows acceptable psychometric properties. The internal consistence measured by Cronbach's resulted in 0.94.", 'timeFrame': 'T0: within the week before the randomisation and the start of the intervention; T1: immediately after completing intervention; T2: 6 months after therapy completion; T3: 12 months after therapy completion; T4: 24 months after therapy completion'}, {'measure': 'Perceived injustice (PI)', 'description': 'The 12-item Injustice Experience Questionnaire (IEQ) will be used to assess perceived injustice. Participants have to rate the frequency of 12 different pain-related statements on a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time). The sum of all items gives the total score which ranges from 0 to 48. The cut off score of 19 is suggestive for a clinically relevant case of perceived injustice.\n\nThis questionnaire obtains two correlated factors: severity/irreparability of loss and blame/unfairness. The Dutch version of the IEQ has good (test-retest) reliability (ICC = 0.86-0.87). The scores obtained using the IEQ are valid.', 'timeFrame': 'T0: within the week before the randomisation and the start of the intervention; T1: immediately after completing intervention; T2: 6 months after therapy completion; T3: 12 months after therapy completion; T4: 24 months after therapy completion'}, {'measure': 'Health care utilization (HCU)', 'description': 'Medical consumption, the type, dose, method of administration and frequency of analgesic, NSAID or symptom-modifying medication, as well as surgeries will be recorded. Health care use will be evaluated using the combination of three questionnaires (online):\n\n1. the Medical Consumption Questionnaire (MCQ)\n2. the Productivity Cost Questionnaire (PCQ)\n3. the EuroQol EQ-5D\n\nThe combination of these questionnaires is advised by the Institute for Medical Technology Assessment, Erasmus University Rotterdam (the Netherlands).', 'timeFrame': 'T0: within the week before the randomisation and the start of the intervention; T1: immediately after completing intervention; T2: 6 months after therapy completion; T3: 12 months after therapy completion; T4: 24 months after therapy completion'}]
Title: Salvage Therapy With Trabectedin in Metastatic Pancreatic Adenocarcinoma: A Single-Arm Phase II Trial | Condition: Pancreatic Cancer | Keywords: recurrent pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas | Summary: | Description: OBJECTIVES: Primary * To assess the therapeutic activity of trabectedin, in terms of progression-free survival (PFS) rate at 6 months, in patients with metastatic pancreatic adenocarcinoma progressed after gemcitabine-containing first-line chemotherapy. Secondary * To assess the safety profile of this drug. * To assess the response rate and response duration. * To assess the overall survival of these patients. * To assess the PFS rate at 9 and 18 weeks. * To perform blood, plasma, and tumor tissue sampling for biological studies, in order to identify biomarkers predictive for resistance or sensitivity to trabectedin, and to characterize the impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity in translational research studies. OUTLINE: Patients receive trabectedin IV over 3 hours on day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Blood samples and tumor tissue are analyzed for identifying biological markers predictive for resistance to treatment and pharmacogenomic and pharmacokinetic profiling on anti-tumor activity in translational research studies. After completion of study treatment, patients are followed up periodically. | ArmGroups: [{'label': 'trabectedin', 'type': 'EXPERIMENTAL', 'description': '1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression', 'interventionNames': ['Drug: trabectedin']}] | Interventions:[{'type': 'DRUG', 'name': 'trabectedin', 'description': '1.3 mg/mq as a 3 hour continuous infusion every three weeks', 'armGroupLabels': ['trabectedin'], 'otherNames': ['YONDELIS']}, {'type': 'DRUG', 'name': 'trabectedin', 'description': '1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression', 'armGroupLabels': ['trabectedin'], 'otherNames': ['ET 743']}] | PrimaryOutcomes: [{'measure': 'Progression-free survival (PFS) rate at 6 months', 'description': 'CT scan', 'timeFrame': 'every 9 weeks'}] | SecondaryOutcomes: [{'measure': 'Safety profile', 'description': 'outpatient visit, laboratory findings', 'timeFrame': 'every 3 weeks'}, {'measure': 'Response rate and response duration', 'description': 'CT scan', 'timeFrame': 'every 2 months'}, {'measure': 'Overall survival', 'description': 'outpatient visit, phone interview', 'timeFrame': 'every 3 weeks during therapy, every 2-3 months thereafter'}, {'measure': 'PFS rate at 9 and 18 weeks', 'description': 'CT scan', 'timeFrame': 'every 9 weeks'}, {'measure': 'Identify biomarkers predictive for resistance or sensitivity to trabectedin', 'description': 'tissue, blood, serum collection', 'timeFrame': 'at trial start'}, {'measure': 'Impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity', 'description': 'blood samples', 'timeFrame': 'based on a pre-definid sample collection schedule'}]
Title: Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel Vs. Sandwich Therapy of Carboplatin and Paclitaxel Followed by Tumor Volume Directed Irradiation Then Further Carboplatin and Paclitaxel | Condition: Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage IIIA Uterine Corpus Cancer, Stage IIIB Uterine Corpus Cancer, Stage IIIC Uterine Corpus Cancer, Stage IVA Uterine Corpus Cancer | Keywords: | Summary: | Description: To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence (increases recurrence-free survival) when compared to sandwich therapy (control arm). To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of death (increases survival) when compared to sandwich therapy (control arm). To compare the regimens with respect to tolerability and acute and late adverse effects of therapy. | ArmGroups: [{'label': 'Regimen I', 'type': 'EXPERIMENTAL', 'description': 'Cisplatin 50 mg/m2 IV Days 1 and 29 plus Volume-directed radiation therapy followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 4 cycles', 'interventionNames': ['Drug: Cisplatin', 'Drug: Carboplatin', 'Drug: Paclitaxel', 'Radiation: Radiation Therapy']}, {'label': 'Regimen II', 'type': 'ACTIVE_COMPARATOR', 'description': 'Carboplatin AUC 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles followed by Volume-directed radiation therapy followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles', 'interventionNames': ['Drug: Carboplatin', 'Drug: Paclitaxel', 'Radiation: Radiation Therapy']}] | Interventions:[{'type': 'DRUG', 'name': 'Cisplatin', 'description': 'Given IV', 'armGroupLabels': ['Regimen I'], 'otherNames': ['Platinol']}, {'type': 'DRUG', 'name': 'Carboplatin', 'description': 'Given IV', 'armGroupLabels': ['Regimen I', 'Regimen II'], 'otherNames': ['Paraplatin']}, {'type': 'DRUG', 'name': 'Paclitaxel', 'description': 'Given IV', 'armGroupLabels': ['Regimen I', 'Regimen II'], 'otherNames': ['Taxol']}, {'type': 'RADIATION', 'name': 'Radiation Therapy', 'description': 'Undergo Radiation Therapy', 'armGroupLabels': ['Regimen I', 'Regimen II'], 'otherNames': ['RT', 'Irradiation']}] | PrimaryOutcomes: [{'measure': 'Recurrence-free survival (RFS)', 'description': "RFS will be assessed by radiology tests, patient's clinical symptoms or physical exam.", 'timeFrame': 'From study entry until disease recurrence, death, or date of last contact, assessed up to 8 years'}] | SecondaryOutcomes: [{'measure': 'Overall survival (OS)', 'description': 'OS assessed by the contact with patient in person or by telephone', 'timeFrame': 'from study entry to death or date of last contact, assessed up to 8 years'}]
Title: A Phase I/II, Open-label, Dose-escalation and Expansion Study to Assess the Safety, Pharmacokinetics and Clinical Activity of NUC-7738, a Nucleotide Analogue, in Patients With Advanced Solid Tumours and Lymphoma | Condition: Advanced Cancer, Lymphoma, Solid Tumor | Keywords: Solid tumors, Lymphoma, Cordycepin, Pembrolizumab | Summary: | Description: N/A | ArmGroups: [{'label': 'NUC-7738', 'type': 'EXPERIMENTAL', 'description': 'NUC-7738 administered by intravenous infusion on a weekly or fortnightly schedule. In the weekly dosing schedule, NUC-7738 is administered on Days 1 and 8 of a 14-day cycle. In the fortnightly dosing schedule, NUC-7738 is administered on Day 1 of a 14-day cycle.', 'interventionNames': ['Drug: NUC-7738']}, {'label': 'NUC-7738 + pembrolizumab', 'type': 'EXPERIMENTAL', 'description': 'NUC-7738 administered by intravenous infusion on a weekly schedule on Days 1, 8 and 15 of a 21-day cycle. Pembrolizumab administered by intravenous infusion every 3 weeks on Day 1 of a 21-day cycle.', 'interventionNames': ['Drug: NUC-7738', 'Drug: Pembrolizumab']}] | Interventions:[{'type': 'DRUG', 'name': 'NUC-7738', 'description': 'NUC-7738', 'armGroupLabels': ['NUC-7738', 'NUC-7738 + pembrolizumab'], 'otherNames': ['Nucleotide Analogue']}, {'type': 'DRUG', 'name': 'Pembrolizumab', 'description': 'Pembrolizumab', 'armGroupLabels': ['NUC-7738 + pembrolizumab'], 'otherNames': ['Keytruda']}] | PrimaryOutcomes: [{'measure': 'Number of patients with dose-limiting toxicities', 'description': 'Phase I: Safety and tolerability of NUC-7738 in patients with advanced solid tumours', 'timeFrame': 'From the date of consent until 30 days after the last dose of NUC-7738 administered'}, {'measure': 'Number of patients with treatment-emergent adverse events (CTCAE v5.0)', 'description': 'Phase I: Safety and tolerability of NUC-7738 in patients with advanced solid tumours', 'timeFrame': 'From the date of consent until 30 days after the last dose of NUC-7738 administered'}, {'measure': 'Number of patients with clinically significant laboratory changes (CTCAE v5.0)', 'description': 'Phase I: Safety and tolerability of NUC-7738 in patients with advanced solid tumours', 'timeFrame': 'From the date of consent until 30 days after the last dose of NUC-7738 administered'}, {'measure': 'Number of patients with changes in physical exam, vital signs, and serial electrocardiograms.', 'description': 'Phase I: Safety and tolerability of NUC-7738 in patients with advanced solid tumours', 'timeFrame': 'From the date of consent until 30 days after the last dose of NUC-7738 administered'}, {'measure': 'MTD for NUC-7738 administered via weekly and fortnightly dosing schedules in patients with advanced solid tumours', 'description': 'Phase I', 'timeFrame': 'Until completion of Phase I (an average of 1 year)'}, {'measure': 'Percentage change from baseline in tumour size', 'description': 'Phase II: Efficacy (per RECIST v 1.1, iRECIST or Cheson et al, 2007)', 'timeFrame': 'Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days) in single-agent cohorts and Cycle 8 in combination cohorts (each cycle is 21 days), moving to every 12 weeks until the end of study (up to 22 months)'}, {'measure': 'Objective response rate (ORR)', 'description': 'Phase II: Efficacy (per RECIST v 1.1, iRECIST or Cheson et al, 2007): defined as the number of patients achieving a confirmed response (complete response \\[CR\\] or partial response \\[PR\\])', 'timeFrame': 'Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days) in single-agent cohorts and Cycle 8 in combination cohorts (each cycle is 21 days), moving to every 12 weeks until the end of study (up to 22 months)'}, {'measure': 'Duration of response (DoR)', 'description': 'Phase II: Efficacy (per RECIST v 1.1, iRECIST or Cheson et al, 2007): defined as the time from the time measurement criteria are first met for CR or PR until the first date that recurrence or progressive disease (PD) is objectively documented (responders only)', 'timeFrame': 'Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days) in single-agent cohorts and Cycle 8 in combination cohorts (each cycle is 21 days), moving to every 12 weeks until the end of study (up to 22 months)'}, {'measure': 'Disease control rate (DCR)', 'description': 'Phase II: Efficacy (per RECIST v 1.1, iRECIST or Cheson et al, 2007): defined as the proportion of patients achieving confirmed response (CR and PR) or stable disease (SD) as the best overall response', 'timeFrame': 'Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days) in single-agent cohorts and Cycle 8 in combination cohorts (each cycle is 21 days), moving to every 12 weeks until the end of study (up to 22 months)'}, {'measure': 'Duration of stable disease (DoSD)', 'description': 'Phase II: Efficacy (per RECIST v 1.1, iRECIST or Cheson et al, 2007): defined as the time from the time measurement criteria are first met for SD until the first date that recurrence or PD is objectively documented', 'timeFrame': 'Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days) in single-agent cohorts and Cycle 8 in combination cohorts (each cycle is 21 days), moving to every 12 weeks until the end of study (up to 22 months)'}, {'measure': 'Progression free survival (PFS)', 'description': 'Phase II: Efficacy (per RECIST v 1.1, iRECIST or Cheson et al, 2007): defined as the time from first dose of study treatment until the date of objective disease progression or death', 'timeFrame': 'Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days) in single-agent cohorts and Cycle 8 in combination cohorts (each cycle is 21 days), moving to every 12 weeks until the end of study (up to 22 months)'}] | SecondaryOutcomes: [{'measure': 'Phase I: Plasma concentration of NUC-7738 at end of infusion (Cinf)', 'timeFrame': 'Samples collected on Days 1, 2, and 3 of Cycle 1 and Days 1 and 2 of Cycle 2 (cycle: 14 days).'}, {'measure': "Phase I: Maximum observed plasma concentration (Cmax) of NUC-7738, 3'-dA, 3'-deoxyinosine (3'-dI) and alanine phosphate metabolite of NUC-7738", 'timeFrame': 'Samples collected on Days 1, 2, and 3 of Cycle 1 and Days 1 and 2 of Cycle 2 (cycle: 14 days).'}, {'measure': "Phase I: Area under the plasma concentration-time curve (AUC) of NUC-7738, 3'-dA, 3'-deoxyinosine (3'-dI) and alanine phosphate metabolite of NUC-7738", 'timeFrame': 'Samples collected on Days 1, 2, and 3 of Cycle 1 and Days 1 and 2 of Cycle 2 (cycle: 14 days).'}, {'measure': "Phase I: Elimination half-life (t½) of NUC-7738, 3'-dA, 3'-deoxyinosine (3'-dI) and alanine phosphate metabolite of NUC-7738", 'timeFrame': 'Single-agent cohorts: Samples collected on Days 1, 2 and 3 of each dose level (cycle: 14 days). Combination cohorts: Samples collected on Days 1, 2, and 3 of Cycle 1 and on Day 1 of the dose escalation step (cycle: 21 days)'}, {'measure': "Phase I: Volume of distribution of NUC-7738, 3'-dA, 3'-deoxyinosine (3'-dI) and alanine phosphate metabolite of NUC-7738", 'timeFrame': 'Single-agent cohorts: Samples collected on Days 1, 2 and 3 of each dose level (cycle: 14 days). Combination cohorts: Samples collected on Days 1, 2, and 3 of Cycle 1 and on Day 1 of the dose escalation step (cycle: 21 days)'}, {'measure': "Phase I: Clearance of NUC-7738, 3'-dA, 3'-deoxyinosine (3'-dI) and alanine phosphate metabolite of NUC-7738", 'timeFrame': 'Single-agent cohorts: Samples collected on Days 1, 2 and 3 of each dose level (cycle: 14 days). Combination cohorts: Samples collected on Days 1, 2, and 3 of Cycle 1 and on Day 1 of the dose escalation step (cycle: 21 days)'}, {'measure': 'Phase II: Plasma concentration of NUC-7738 at end of infusion (Cinf)', 'timeFrame': 'Single-agent cohorts: Samples collected on Days 1, 2 and 3 of each dose level (cycle: 14 days). Combination cohorts: Samples collected on Days 1, 2, and 3 of Cycle 1 and on Day 1 of the dose escalation step (cycle: 21 days)'}, {'measure': "Phase II: Maximum observed plasma concentration (Cmax) of NUC-7738, 3'-dA, 3'-deoxyinosine (3'-dI) and alanine phosphate metabolite of NUC-7738", 'timeFrame': 'Single-agent cohorts: Samples collected on Days 1, 2 and 3 of each dose level (cycle: 14 days). Combination cohorts: Samples collected on Days 1, 2, and 3 of Cycle 1 and on Day 1 of the dose escalation step (cycle: 21 days)'}, {'measure': "Phase II: Area under the plasma concentration-time curve (AUC) of NUC-7738, 3'-dA, 3'-deoxyinosine (3'-dI) and alanine phosphate metabolite of NUC-7738", 'timeFrame': 'Single-agent cohorts: Samples collected on Days 1, 2 and 3 of each dose level (cycle: 14 days). Combination cohorts: Samples collected on Days 1, 2, and 3 of Cycle 1 and on Day 1 of the dose escalation step (cycle: 21 days)'}, {'measure': "Phase II: Elimination half-life (t½) of NUC-7738, 3'-dA, 3'-deoxyinosine (3'-dI) and alanine phosphate metabolite of NUC-7738", 'timeFrame': 'Single-agent cohorts: Samples collected on Days 1, 2 and 3 of each dose level (cycle: 14 days). Combination cohorts: Samples collected on Days 1, 2, and 3 of Cycle 1 and on Day 1 of the dose escalation step (cycle: 21 days)'}, {'measure': "Phase II: Volume of distribution of NUC-7738, 3'-dA, 3'-deoxyinosine (3'-dI) and alanine phosphate metabolite of NUC-7738", 'timeFrame': 'Single-agent cohorts: Samples collected on Days 1, 2 and 3 of each dose level (cycle: 14 days). Combination cohorts: Samples collected on Days 1, 2, and 3 of Cycle 1 and on Day 1 of the dose escalation step (cycle: 21 days)'}, {'measure': "Phase II: Clearance of NUC-7738, 3'-dA, 3'-deoxyinosine (3'-dI) and alanine phosphate metabolite of NUC-7738", 'timeFrame': 'Single-agent cohorts: Samples collected on Days 1, 2 and 3 of each dose level (cycle: 14 days). Combination cohorts: Samples collected on Days 1, 2, and 3 of Cycle 1 and on Day 1 of the dose escalation step (cycle: 21 days)'}, {'measure': 'Percentage change from baseline in tumour size', 'description': 'Phase I: Efficacy (per RECIST v 1.1 or Cheson et al, 2007)\n\nThe percentage change in the sum of longest diameters of target lesions from baseline to Week 8.\n\nThe best percentage change in the sum of longest diameters of target lesions from baseline to best on-treatment measurement', 'timeFrame': 'Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days), moving to every 12 weeks until the end of study (up to 22 months)'}, {'measure': 'ORR', 'description': 'Phase I: Efficacy (per RECIST v 1.1 or Cheson et al, 2007): defined as the number of patients achieving a confirmed response (complete response \\[CR\\] or partial response \\[PR\\])', 'timeFrame': 'Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days), moving to every 12 weeks until the end of study (up to 22 months)'}, {'measure': 'DoR', 'description': 'Phase I: Efficacy (per RECIST v 1.1 or Cheson et al, 2007): defined as the time from the time measurement criteria are first met for CR or PR until the first date that recurrence or progressive disease (PD) is objectively documented (responders only)', 'timeFrame': 'Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days), moving to every 12 weeks until the end of study (up to 22 months)'}, {'measure': 'DCR', 'description': 'Phase I: Efficacy (per RECIST v 1.1 or Cheson et al, 2007): defined as the proportion of patients achieving confirmed response (CR and PR) or stable disease (SD) as the best overall response', 'timeFrame': 'Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days), moving to every 12 weeks until the end of study (up to 22 months)'}, {'measure': 'DoSD', 'description': 'Phase I: Efficacy (per RECIST v 1.1 or Cheson et al, 2007): defined as the time from the time measurement criteria are first met for SD until the first date that recurrence or PD is objectively documented', 'timeFrame': 'Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days), moving to every 12 weeks until the end of study (up to 22 months)'}, {'measure': 'PFS', 'description': 'Phase I: Efficacy (per RECIST v 1.1 or Cheson et al, 2007): defined as the time from first dose of study treatment until the date of objective disease progression or death', 'timeFrame': 'Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days), moving to every 12 weeks until the end of study (up to 22 months)'}, {'measure': 'Number of patients with treatment-emergent adverse events (CTCAE v5.0)', 'description': 'Phase II: Safety and tolerability of NUC-7738 as a single-agent or in combination with pembrolizumab in patients with advanced solid tumours and lymphoma', 'timeFrame': 'From the date of consent until 30 days after the last dose of NUC-7738 administered'}, {'measure': 'Number of patients with clinically significant laboratory changes (CTCAE v5.0)', 'description': 'Phase II: Safety and tolerability of NUC-7738 as a single-agent or in combination with pembrolizumab in patients with advanced solid tumours and lymphoma', 'timeFrame': 'From the date of consent until 30 days after the last dose of NUC-7738 administered'}, {'measure': 'Number of patients with changes in physical exam, vital signs, and serial electrocardiograms.', 'description': 'Phase II: Safety and tolerability of NUC-7738 as a single-agent or in combination with pembrolizumab in patients with advanced solid tumours and lymphoma', 'timeFrame': 'From the date of consent until 30 days after the last dose of NUC-7738 administered'}]
Title: An Intervention to Improve Decision Role Concordance Amongst Newly Diagnosed Breast Cancer Patients | Condition: Breast Cancer | Keywords: early stage breast cancer;, treatment decision making, newly diagnosed breast cancer | Summary: | Description: The goal of this project is to test the effects of the Patient Preference Scale as the basis for a clinical intervention for role negotiation in breast cancer surgery decisions and the Patient Perception Scale to measure role concordance. The investigators hypothesize that better role concordance will be achieved with a simple provider-based intervention. In addition, role concordance will be associated with improved short-term and longer-term improvements in outcomes of the following parameters: a) satisfaction with decision process b) breast specific QOL, and c) decision regret. The investigators propose a mixed methods, interventional study with concurrent controls performed in a breast cancer surgery clinic at a comprehensive cancer center. The Patient Preference Scale will be used to identify the preferred involvement in decision making of newly diagnosed breast cancer patients prior to their first clinic visit. The Patient Perception Scale will be used after the encounter in order to evaluate role concordance. The Provider Perception Scale will also be used to assess the perception of the achieved role by the provider. In the first half of the study, providers will be blind to the patient's preferred role. In the second half, providers will be made aware of the preferred role prior to the encounter and will have a brief conversation with the patient about their desired role in the decision making process. Clinical encounters will be audiotaped, transcribed, and scored for patient involvement. The investigators propose the following aims and hypotheses: Investigate the impact of a brief provider-led intervention about the patients' preferred role in treatment decision making on role concordance. The investigators hypothesize that: 1. Role concordance will be improved when the preferred role is discussed with the patient at the beginning of the encounter. 2. The provider's perception of the role achieved will be more concordant with the patient's perception when the preferred role is discussed. 3. Investigate the impact of role concordance in the treatment decision making process on short term and long term quality of life and decision outcomes. The investigators hypothesize that: Patients who achieve role concordance will be more satisfied with the decision process. 1. Patients who achieve role concordance will have better QOL and less decision regret at early (2 to 6 weeks) and later (6 months) time points after the clinic visit. 2. Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments. 3. Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments | ArmGroups: [{'label': 'The non-intervention control group', 'type': 'NO_INTERVENTION', 'description': "In the non-intervention control group, providers are blind to the patient's preferred decision making role."}, {'label': 'The intervention group', 'type': 'EXPERIMENTAL', 'description': 'The provider will be informed of the patient preference in treatment decision making (preferred role) and have a discussion about this with the patient in the intervention group.', 'interventionNames': ['Behavioral: Patient Preference in Treatment Decision Making']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Patient Preference in Treatment Decision Making', 'description': "The roles are divided into two active roles, a collaborative (or shared) role, and two passive roles in the Patient Preference scale questionnaire. Once the questionnaire is administered, the patient will then proceed to original surgical appointment. The provider is informed of the patient's preferred role and has a discussion with them patient about this in the intervention group, but not in the control group.", 'armGroupLabels': ['The intervention group']}] | PrimaryOutcomes: [{'measure': 'Decision role concordance before and after a surgical consultation', 'description': "The primary outcome measures the changes from patient's preferred role in baseline (before a surgical consultation) to the perception of whether the patient achieved the preferred role (immediately after a surgical consultation) in the surgical consultation.", 'timeFrame': 'The estimated period is 3 hours (before and immediately after a surgical consultation)'}, {'measure': 'Decision role concordance of provider and patient', 'description': "It measures the difference in the patient's perception of the achieved role and provider's perception of the patient's preferred role.", 'timeFrame': 'This is an one-time measurement (Immediately after a surgical consultation)'}] | SecondaryOutcomes: [{'measure': "Patient's satisfaction with the decision making process", 'description': 'Satisfaction with the decision making process will be measured directly after the clinic encounter using a modified version of the Holmes-Rovner Satisfaction with Decision scale. The scale uses a Likert-type ranking of 6 items related to decision making, with 1 being strongly disagree and 5 being strongly agree.', 'timeFrame': 'immediately after a surgical consultation'}, {'measure': 'Comparing Reliability and Validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) assessment of short-term quality of life between the groups', 'description': 'Quality of life will be assessed using the (FACT-B) questionnaire. FACT-B measures 27 items in five different areas: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns specific to this patient population. FACT-B is measured on the scale from 0 to 4, with a total minimum score of 0 and maximum score of 144.', 'timeFrame': 'This scale will be used prior to the first consultation to establish a baseline for each patient and will subsequently be used at 2 weeks and 6 months after initial clinic visit.'}, {'measure': 'The Decision Regret outcome', 'description': 'The decision regret outcome will be measured using the Decision Regret Scale. The Decision Regret Scale is is a 5 item scale with items ranked on a 5-point Likert-type scale and added together with higher score indicating more regret.', 'timeFrame': 'The scale will be administered at 2 weeks and 6 months after initial clinic visit.'}, {'measure': 'Observing Patient Involvement in Decision Making (OPTION) assessment of patient involvement', 'description': 'The outcome of patient involvement at the clinic encounter will be measured using the OPTION scale. This scale measures 12 item from 0 to 4, with 0 being "this behavior is not observed" to 4 "This behavior is exhibited to a very high standard"', 'timeFrame': '4 months after initial clinic visit'}, {'measure': 'completion or intention to complete therapies', 'description': "Group differences in completion or intention to complete recommended therapies will be assessed at 6 months after the clinic visit through chart review of all participants' charts.", 'timeFrame': '6 months after initial clinic visit'}]
Title: Real-world Treatment Patterns and Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as Initial Endocrine Based Therapy in Metastatic/Advanced Breast Cancer | Condition: Metastatic Breast Cancer | Keywords: Breast cancer, Palbociclib, Real-world data, Retrospective study, Effectiveness | Summary: | Description: Utilizing de-identified data derived from the Flatiron Health Analytic Database, the retrospective observational study is to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2-MBC in the US real-world clinical practice setting. Patients will be evaluated retrospectively from index therapy date to death, or last visit in the database, whichever comes first. Descriptive and multivariate statistical analyses will be performed. | ArmGroups: [{'label': 'Palbociclib + an aromatase inhibitor', 'description': 'Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database.', 'interventionNames': ['Drug: Palbociclib + an aromatase inhibitor']}, {'label': 'Palbociclib + Letrozole', 'description': 'Adult metastatic breast cancer patients who initiated Palbociclib +Letrozole as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database.', 'interventionNames': ['Drug: Palbociclib + Letrozole']}, {'label': 'Letrozole', 'description': 'Adult metastatic breast cancer patients who initiated Letrozole as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database.', 'interventionNames': ['Drug: Letrozole']}] | Interventions:[{'type': 'DRUG', 'name': 'Palbociclib + an aromatase inhibitor', 'description': 'Palbociclib + an aromatase inhibitor therapy', 'armGroupLabels': ['Palbociclib + an aromatase inhibitor']}, {'type': 'DRUG', 'name': 'Palbociclib + Letrozole', 'description': 'Palbociclib + Letrozole therapy', 'armGroupLabels': ['Palbociclib + Letrozole']}, {'type': 'DRUG', 'name': 'Letrozole', 'description': 'Letrozole monotherapy', 'armGroupLabels': ['Letrozole']}] | PrimaryOutcomes: [{'measure': 'Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method', 'description': 'rwPFS was defined as time (in months) from index date to death or disease progression (growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment) or end of record or end of data availability, whichever occurred first. If participants did not die or had disease progression, they were censored at the date of initiation of next line of therapy for participants with two or more lines of therapy or their last visit date for participants with only one line of therapy. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.', 'timeFrame': 'From index date to death or disease progression or end of record/data availability or censored date, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)'}] | SecondaryOutcomes: [{'measure': 'Overall Survival (OS): Using Kaplan-Meier Method', 'description': 'OS was defined as time (in months) from index date to the date of death. Participants who did not die during the period were censored at the time of data cut-off. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.', 'timeFrame': 'From index date to death, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)'}, {'measure': 'Number of Participants With Real World Tumour Response (rwTR)', 'description': 'rwTR was determined based on complete response (CR), partial response (PR), stable disease (SD), progressive disease(PD), indeterminate and not documented. CR was defined as complete resolution of all visible disease. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no change in overall size of visible disease; also included cases where some lesions increased in size and some lesions decreased in size. PD was determined based on growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment. Index date was defined as the start date of the first line therapy for Palbociclib + AI.', 'timeFrame': 'From index date to CR/PR/PD/SD pr PD, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)'}, {'measure': 'Response Rate', 'description': 'Response rate was defined as number of participants with complete response or partial response divided by the number of participants with at least one tumor assessment while on the index treatment. Index date was defined as the start date of the first line therapy for Palbociclib + AI. The result of this outcome measure was measured in terms of proportion of participants.', 'timeFrame': 'From index date to CR or PR, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)'}, {'measure': 'Real-World Duration of Treatment (rwDOT): Using Kaplan-Meier Method', 'description': 'rwDOT was defined as time (in months) from index treatment initiation to end of the treatment. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.', 'timeFrame': 'From index treatment initiation up to end of treatment, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)'}, {'measure': 'Time From Index Date to Next Line of Anti-Cancer Therapy: Using Kaplan-Meier Method', 'description': 'The time (in months) from index treatment initiation to next line of anti-cancer therapy or death from any cause, whichever occurred first was reported in this outcome measure. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.', 'timeFrame': 'From index treatment initiation up to next line of anti-cancer therapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)'}, {'measure': 'Time to First Use of Chemotherapy: Using Kaplan-Meier Method', 'description': 'The time (in months) from index treatment initiation to first use of chemotherapy or death from any cause, whichever occurred first was reported in this outcome measure. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.', 'timeFrame': 'From index treatment initiation to first use of chemotherapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)'}]
Title: Real-time Artificial Intelligence-based Endocytoscopic Diagnosis of Colorectal Neoplasms: a Single Center, Prospective Clinical Study | Condition: Colorectal Neoplasms | Keywords: endocytoscopy, artificial intelligence | Summary: | Description: N/A | ArmGroups: [{'label': 'colorectal lesion', 'interventionNames': ['Diagnostic Test: artificial intelligence system']}] | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'artificial intelligence system', 'description': 'The colorectal lesions had been observed with EC-NBI and EC-stained by endoscopists before treatment that were ultimately performed histopathologic examination. The endocytoscopies (CF-H290ECI, Olympus, Tokyo, Japan) have a maximum magnification of ×520, focusing depth, 35 μm; field of view, 570 × 500μm. During EC-NBI , the endoscopist pushed the button of the endoscope to switch from white-light imaging to NBI and observed the lesion with full magnification. After endocytoscopic observation, the artificial intelligence system will be open and display the predictive result. Finally, the endoscopist performed EC-stained mode diagnosis after staining the lesion surface with 1.0% methylene blue. After endocytoscopic observation, the artificial intelligence system will be open again and display the predictive result.', 'armGroupLabels': ['colorectal lesion'], 'otherNames': ['endocytoscopy']}] | PrimaryOutcomes: [{'measure': 'sensitivity', 'timeFrame': 'December 2024'}, {'measure': 'specificity', 'timeFrame': 'December 2024'}, {'measure': 'accuracy', 'timeFrame': 'December 2024'}, {'measure': 'positive predictive value', 'timeFrame': 'December 2024'}, {'measure': 'negative predictive value', 'timeFrame': 'December 2024'}, {'measure': 'high confidence diagnosis rate', 'timeFrame': 'December 2024'}] | SecondaryOutcomes: N/A
Title: An Open Label Single Arm Phase II Trial in Patients With Advanced Unresectable Previously Treated Oesophagogastric Adenocarcinoma Which is MGMT Deficient | Condition: Adenocarcinoma - GEJ, Cancer of Esophagus | Keywords: cancer, Oesophagogastric, Oesophagogastric adenocarcinoma,, MGMT deficient,, O6-methylguanine-DNA-methyltransferase, MGMT protein, human, MGMT methylated | Summary: | Description: The aim of the ELEVATE trial is to determine the activity and safety of maintenance TMZ dosing followed by nivolumab treatment to evaluate the potential for a future randomised trial against a standard of care control arm. The rationale to continue TMZ for 3 months or until PD is to evaluate the emergence of mismatch repair deficiency both with and without radiological PD, as clinically relevant MMRd may emerge before radiological progression. This will also reduce the number of patients who drop out due to symptomatic progressive disease. | ArmGroups: [{'label': 'Treatment', 'type': 'EXPERIMENTAL', 'description': "Metronomic TMZ 50mg/m2/day orally for 3 months, then nivolumab 240mg IV until progression.\n\nMetronomic TMZ 50mg/m2/day orally until progression then nivolumab 240mg IV until progression. Patients who progress on TMZ will start monotherapy with nivolumab.\n\nMetronomic TMZ50mg/m2/day orally for 3 months, then nivolumab 240mg IV +/- TMZ until progression. Patients who don't progress on TMZ will commence with combination treatment; TMZ + Nivolumab at 3 mths until they progress\n\nMetronomic TMZ 50mg/m2/day orally for 3 months, then nivolumab 240mg IV +/- TMZ until 24 months. Patients will remain on combination therapy up to a maximum of 24mths.", 'interventionNames': ['Drug: Temozolomide', 'Drug: Temozolomide 50mg/m2/day', 'Drug: Temozolomide 3 month', 'Drug: Temozolomide 24month']}] | Interventions:[{'type': 'DRUG', 'name': 'Temozolomide', 'description': "Metronomic TMZ 50mg/m2/day orally for 3 months then nivolumab 240mg IV +/- TMZ until progression.\n\nPatients who don't progress on TMZ will commence with combination treatment; TMZ + Nivolumab at 3 mths. Patients who progress on TMZ will start monotherapy with nivolumab. Patients will remain on monotherapy with nivolumab or combination therapy until progression or up to a maximum of 24mths.", 'armGroupLabels': ['Treatment'], 'otherNames': ['Nivolumab']}, {'type': 'DRUG', 'name': 'Temozolomide 50mg/m2/day', 'description': 'Metronomic TMZ 50mg/m2/day orally until progression then nivolumab 240mg IV until progression', 'armGroupLabels': ['Treatment'], 'otherNames': ['Nivolumab']}, {'type': 'DRUG', 'name': 'Temozolomide 3 month', 'description': 'Metronomic TMZ 50mg/m2/day orally for 3 months, then nivolumab 240mg IV and TMZ until progression.', 'armGroupLabels': ['Treatment'], 'otherNames': ['Nivolumab']}, {'type': 'DRUG', 'name': 'Temozolomide 24month', 'description': 'Metronomic TMZ 50mg/m2/day orally for 3 months, then nivolumab 240mg IV and TMZ until a maximum of 24 months', 'armGroupLabels': ['Treatment'], 'otherNames': ['Nivolumab']}] | PrimaryOutcomes: [{'measure': 'Tumour Response to nivolumab', 'description': 'To determine the anti-tumour activity of nivolumab, when given after temozolomide in patients with previously treated advanced oesophagogastric adenocarcinoma which are MGMT methylated.', 'timeFrame': '24 months'}] | SecondaryOutcomes: [{'measure': 'The percentage of patients who have achieved response', 'description': 'The Disease control rate determine the effect of TMZ priming followed by nivolumab on disease control rates of patients with previously treated advanced oesophagogastric adenocarcinoma which is MGMT methylated.\n\nDisease control rate, according to RECIST v1.1 and iRECIST, 6 months after starting nivolumab, and 3 months after starting TMZ, respectively.', 'timeFrame': '6 months'}]
Title: Phase 2 Single-Arm Studies of Gemcitabine in Combination With Oxaliplatin Refractory and Relapsed Pediatric Solid Tumors | Condition: Medulloblastoma, Central Nervous System Tumors, Neuroblastoma, Osteosarcoma | Keywords: Gemcitabine, Oxaliplatine, Paediatric solid tumors, Other CNS tumors, Other miscellaneous solid non-CNS tumours | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'Gemcitabine (Gemzar®), Oxaliplatin (Eloxatin®)'}] | PrimaryOutcomes: [{'measure': 'The primary endpoint for efficacy is the percentage of patients achieving complete or partial response according to WHO guidelines, after having received 4 cycles of gemcitabine-oxaliplatin (8 weeks).'}] | SecondaryOutcomes: [{'measure': 'The secondary efficacy variables are the duration of response, the time to treatment failure, the time to progressive disease and the overall survival.'}, {'measure': 'Clinical and laboratory toxicities/symptomatology will be graded according to NCI-Common toxicity criteria AE v3.0'}]
Title: Targeted Intra-arterial Gemcitabine Vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following Induction with Sequential IV Gemcitabine Plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer | Condition: Locally Advanced Pancreatic Cancer | Keywords: | Summary: | Description: All subjects will receive induction therapy of IV gemcitabine plus nab-paclitaxel, as well as SBRT radiation therapy for approximately a total of four months. Subjects who remain eligible will then be randomized to receive either intra-arterial chemotherapy with gemcitabine; or to continue gemcitabine plus nab-paclitaxel. Subjects will receive the randomized treatments for up to 16 weeks or until progression. Both groups will receive either IV gemcitabine and nab-paclitaxel or oral capecitabine following the 16-week treatment course until disease progression at the discretion of the Investigator and then followed for survival for five years. | ArmGroups: [{'label': 'IA Therapy', 'type': 'EXPERIMENTAL', 'description': 'IA Treatments with 1,000 mg/m2 gemcitabine administered through RenovoCath every other week for a maximum of 8 treatments for approximately 16 weeks.', 'interventionNames': ['Drug: Gemcitabine', 'Device: RenovoCath']}, {'label': 'IV Therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'IV gemcitabine and nab-paclitaxel will be administered for 16 weeks on days 1, 8, and 15 of a 28 day cycle. Nab-paclitaxel will be administered intravenously following pre-medication at a dose of 125 mg/m2 over 30 minutes followed by an infusion of gemcitabine at a dose of 1000 mg/m2 over 30 minutes.', 'interventionNames': ['Drug: Gemcitabine', 'Drug: nab-paclitaxel']}] | Interventions:[{'type': 'DRUG', 'name': 'Gemcitabine', 'description': 'Chemotherapy', 'armGroupLabels': ['IA Therapy', 'IV Therapy'], 'otherNames': ['Gemzar']}, {'type': 'DRUG', 'name': 'nab-paclitaxel', 'description': 'Chemotherapy', 'armGroupLabels': ['IV Therapy'], 'otherNames': ['Abraxane']}, {'type': 'DEVICE', 'name': 'RenovoCath', 'description': 'Intra-arterial catheter', 'armGroupLabels': ['IA Therapy']}] | PrimaryOutcomes: [{'measure': 'Overall Survival', 'description': 'OS from time of randomization will be calculated using the Kaplan-Meier method and compared between the test and control groups using the stratified Log-Rank Test', 'timeFrame': 'Up to Five Years'}] | SecondaryOutcomes: [{'measure': 'Overall Survival for treatment received and unresected populations', 'description': 'The primary endpoint analysis will be repeated for the Treatment Received and Unresected Subject populations.', 'timeFrame': 'Up to Five Years'}, {'measure': 'Progression Free Survival', 'description': 'To compare the Progression Free Survival of intra-arterial delivery of gemcitabine using the RenovoCath™ device vs. continuation of IV gemcitabine and nab-paclitaxel following induction therapy with gemcitabine and nab-paclitaxel and radiation treatment for locally advanced pancreatic adenocarcinoma. Disease response and progression will be assessed according to RECIST 1.1.', 'timeFrame': 'Up to Five Years'}, {'measure': 'Objective response rate and duration of response', 'description': 'Objective response is defined as a complete response, CR, or partial response, PR, determined by Investigator assessment and confirmed by repeat assessment ≥ 4 weeks after initial documentation.', 'timeFrame': 'Up to Five Years'}, {'measure': 'Health Related Quality of Life', 'description': 'The EORTC questionnaire will be used to assess health related quality of life. The summary scores for the EORTC questionnaire will be calculated at baseline and follow-up.', 'timeFrame': 'Up to Five Years'}, {'measure': 'Neuropathy Assessment', 'description': 'The degree of neuropathy will be measured by the FACT/GOG-NTX-4 (version 4). The results will be cross tabulated by randomized treatment group for each study visit.', 'timeFrame': '1 Year'}, {'measure': 'Frequency of neutropenia', 'description': 'Neutropenia with onset after randomization requiring the use of filgrastim or other medications for white blood cell stimulation will be compared between the test and control groups through progression of disease.', 'timeFrame': '1 Year'}, {'measure': 'Patient reported symptoms', 'description': 'Symptoms reported by subjects using the PRO-CTCAE questionnaire will be compared between the test and control groups through progression of disease.', 'timeFrame': 'Up to Five Years'}, {'measure': 'Safety, defined as adverse event rate, and tolerability, defined as occurrence of treatment discontinuation', 'description': 'Safety and tolerability will be assessed by the occurrence of treatment discontinuation and the presence of adverse events', 'timeFrame': 'Up to Five Years'}]
Title: A Pilot Randomized, Placebo Controlled, Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome | Condition: Breast Cancer, Ovarian Neoplasm, Pain | Keywords: omega-3, fatty acids, paclitaxel, acute pain syndrome, peripheral neuropathy, chemotherapy induced neuropathy | Summary: | Description: One mechanism proposed for P-APS is an early inflammatory process characterized by macrophage activation in both the dorsal root ganglia and peripheral nerve occurring shortly after paclitaxel therapy. Morphologic alterations in DRG satellite cells have been noted and upregulation of proinflammatory cytokines have been hypothesized as early events in the development of neuropathy. Therefore, it is possible that paclitaxel-induced neuropathic pain may be mediated by pro-inflammatory cytokines. If P-APS and chronic neuropathy are indeed part of a continuum, the inflammatory pathway would be a reasonable target for therapy. While the mechanism of how paclitaxel leads to the development of neuropathy is still not understood, it has been hypothesized that its microtubule-stabilizing effects disrupt axonal transport. Intervention with an agent that is both anti-inflammatory as well as neuroprotective is therefore worth exploring. Long chain omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are common dietary supplements. They have well established anti-inflammatory properties which serve as the basis for their use in therapeutic trials in inflammatory conditions. Omega -3 fatty acids consumption can attenuate the production of pro-inflammatory metabolites. In addition, it can generate local mediators that facilitate resolution of inflammation. Thus, if P-APS is indeed mediated by inflammation, the anti-inflammatory activity of omega 3 fatty acids may be one mechanism to prevent P-APS. Additionally, given its well established safety profile, it may be an attractive alternative to NSAIDS. A dose of at least 2.7 g/day of EPA and DHA have been reported to have analgesic effects in inflammatory conditions. The dose of 4 g/day is an FDA-approved dose of omega 3 fatty acids (Lovaza) for the treatment of hypertriglyceridemia and has a well-documented toxicity profile. On the basis of this, a dose of 4 g/day was selected for this study. Lovaza (omega-3-acid ethyl esters) capsules will be used. Each 1-gram capsule contains approximately 465 mg EPA and 375 mg DHA. | ArmGroups: [{'label': 'Arm I (Omega-3 fatty acid)', 'type': 'EXPERIMENTAL', 'description': 'Four Omega-3 fatty acid capsules (at 1 gram/capsule) are administered orally daily.\n\nThe capsules may be administered either once daily or as 2 capsules two times daily.', 'interventionNames': ['Dietary Supplement: Omega-3 fatty acid', 'Drug: Paclitaxel']}, {'label': 'Arm II (placebo)', 'type': 'PLACEBO_COMPARATOR', 'description': 'Four placebo capsules (at 1 gram microcrystalline cellulose/capsule) are administered orally daily.\n\nThe capsules may be administered either once daily or as 2 capsules two times daily.', 'interventionNames': ['Dietary Supplement: Placebo', 'Drug: Paclitaxel']}] | Interventions:[{'type': 'DIETARY_SUPPLEMENT', 'name': 'Omega-3 fatty acid', 'description': 'Patients receive omega-3 fatty acid capsules orally beginning 1 week prior to paclitaxel treatment.\n\nCapsule administration continues until paclitaxel is discontinued or for 12 weeks maximum (whichever comes first).\n\nEach 1-gram capsule contains approximately 465 mg eicosapentaenoic acid (EPA) and 375 mg docosahexaenoic acid (DHA).', 'armGroupLabels': ['Arm I (Omega-3 fatty acid)'], 'otherNames': ['Fish oil', 'n-3 fatty acid', 'O3FA', 'Lovaza']}, {'type': 'DIETARY_SUPPLEMENT', 'name': 'Placebo', 'description': 'Patients receive placebo capsules orally beginning 1 week prior to paclitaxel treatment.\n\nCapsule administration continues until paclitaxel is discontinued or for 12 weeks maximum (whichever comes first)', 'armGroupLabels': ['Arm II (placebo)']}, {'type': 'DRUG', 'name': 'Paclitaxel', 'description': 'Patients will receive, as part of their standard of care, weekly paclitaxel at 70 to 90 mg/m2 intravenously for a minimum of 2 months. Treatment 3 out of 4 weeks is allowed.', 'armGroupLabels': ['Arm I (Omega-3 fatty acid)', 'Arm II (placebo)'], 'otherNames': ['Taxol']}] | PrimaryOutcomes: [{'measure': 'Mean severity of pain', 'description': 'Differences between groups will analyzed via t-tests or Wilcoxon rank-sum tests as appropriate.', 'timeFrame': 'Up to 1 month after completion of therapy'}] | SecondaryOutcomes: [{'measure': 'Incidence of pain or relief', 'description': "Fisher's exact test will be used for the incidence variable with 95% confidence intervals.", 'timeFrame': 'Up to 1 month after completion of therapy'}]
Title: A Phase 1 Open Label, Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension), Given by Intravenous Infusion to Patients With Advanced or Metastatic Cancer | Condition: Metastatic Cancer, Cancer, Solid Tumors | Keywords: Cancer, Neoplasms, Solid Tumor, Ovarian Cancer, Lung Cancer, Non-Small Cell Lung Cancer, Pancreatic Cancer, Breast Cancer, Endometrial Cancer, Melanoma, Prostate Cancer, Skin Cancer, Head and Neck Cancer, Solid Malignancies | Summary: | Description: The study is designed to explore the safety, tolerability, pharmacokinetics and pharmacodynamics of BIND-014 and define a recommended Phase 2 dose of BIND-014. All cycles of therapy will consist of the patient taking BIND-014 intravenously once every three weeks or weekly for three out of four weeks. | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'BIND-014'}] | PrimaryOutcomes: [{'measure': 'To assess the dose limiting toxicities (DLTs) of BIND-014 when on day 1 of a 21-day cycle or when given on day 1, 8 and 15 of a 28-day cycle.', 'description': 'This information will be used to determine the maximum tolerated dose (MTD) of BIND-014 when given weekly or three weeks.'}] | SecondaryOutcomes: [{'measure': 'To characterize the pharmacokinetics of BIND-014 following an IV infusion.', 'description': 'Pharmacokinetic parameters such as time to peak concentration (Tmax), peak concentration (Cmax), minimum concentration (Cmin), volume of distribution (Vd), half life (t1/2), total body clearance (CL) and area under the concentration-time curve (AUC) will be determined for each patient using plasma concentration data.', 'timeFrame': 'First two cycles of BIND-014'}, {'measure': 'To assess any preliminary evidence of anti-tumor activity observed with BIND-014.', 'timeFrame': '18 months'}, {'measure': 'To assess changes in serum tumor markers when appropriate.', 'timeFrame': '18 months'}]
Title: Biological Analysis of Ethnic Variations in Wilms Tumor | Condition: Kidney Cancer | Keywords: recurrent Wilms tumor and other childhood kidney tumors, stage I Wilms tumor, stage II Wilms tumor, stage III Wilms tumor, stage IV Wilms tumor, stage V Wilms tumor | Summary: | Description: OBJECTIVES: * To determine a unique molecular "finger print" of primary Wilms tumor arising in ethnically diverse children who are at increased risk to develop this lethal malignancy and subsequently relapse. * To determine a unique protein "finger print" from the urine of ethnically diverse children who develop Wilms tumor and subsequent relapse. OUTLINE: Formalin-fixed paraffin-embedded and snap-frozen primary tissue samples, and urine samples collected at the time of diagnosis and before treatment, are analyzed for molecular and protein profile by MALDI-TOF mass spectroscopy, western blotting, immunohistochemistry, and reverse-transcriptase polymerase chain reaction (RT-PCR) assays. | ArmGroups: N/A | Interventions:[{'type': 'GENETIC', 'name': 'gene expression analysis'}, {'type': 'GENETIC', 'name': 'proteomic profiling'}, {'type': 'GENETIC', 'name': 'reverse transcriptase-polymerase chain reaction'}, {'type': 'GENETIC', 'name': 'western blotting'}, {'type': 'OTHER', 'name': 'immunohistochemistry staining method'}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis'}, {'type': 'PROCEDURE', 'name': 'spectroscopy'}] | PrimaryOutcomes: [{'measure': 'Molecular "finger print" of primary Wilms tumor in ethnically diverse children'}, {'measure': 'Protein "finger print" from the urine of ethnically diverse children'}] | SecondaryOutcomes: N/A
Title: Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung : a Randomized Non Comparative Phase II Trial | Condition: Advanced Non-small Cell Lung Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'UCPVax + Nivolumab', 'type': 'EXPERIMENTAL', 'description': 'UCPVax vaccine (0,5 mg)\n\nNivolumab (480 mg)', 'interventionNames': ['Drug: UCPVax + Nivolumab']}, {'label': 'Standard second line chemotherapy', 'type': 'OTHER', 'description': 'Standard second line chemotherapy at the choice of the investigator.\n\nThis arm will permit to assess the good calibration of the hypothesis on the experimental arm.', 'interventionNames': ['Drug: standard chemotherapy']}] | Interventions:[{'type': 'DRUG', 'name': 'UCPVax + Nivolumab', 'description': 'UCPVax will be administrated at day 1 of week 1 ; 2 ; 3 ; 5 ; 6 ; 7 and then week 13 and every 2 months until months 12.\n\nNivolumab will be administrated at the dose of 480 mg at day 1 and then every 4 weeks until disease progression or unacceptable toxicity according to label.\n\nAt the end of COMBO phase, nivolumab will be continued every 4 weeks for maximum 24 months from the first administration, until disease progression or unacceptable toxicity according to standard of care.', 'armGroupLabels': ['UCPVax + Nivolumab']}, {'type': 'DRUG', 'name': 'standard chemotherapy', 'description': 'Second line chemotherapy at the choice of the investigator', 'armGroupLabels': ['Standard second line chemotherapy']}] | PrimaryOutcomes: [{'measure': '6 months Progression-Free Survival (PFS) rate', 'description': 'PFS is defined by the duration from the date of initiation of the treatment to the disease progression (RECIST) or death from any cause whichever occurs first, censoring cases without progression at the date of last disease assessment.', 'timeFrame': '6 months after the date of initiation of treatment (1st day of 1st cycle of chemotherapy)'}] | SecondaryOutcomes: N/A
Title: Efficacy and Safety of Fruquintinib in Combination With PD-1 Inhibitors as First-line Maintenance Therapy for Advanced HER-2 Negative Gastric Cancer: a Single-arm, Prospective, Exploratory Clinical Study | Condition: Gastric Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Experimental', 'type': 'EXPERIMENTAL', 'description': 'Fruquintinib+PD-1', 'interventionNames': ['Drug: Fruquintinib+PD-1']}] | Interventions:[{'type': 'DRUG', 'name': 'Fruquintinib+PD-1', 'description': 'This is a one-arm, prospective, exploratory clinical study, including patients with advanced HER-2-negative gastric cancer (including gastroesophageal junction adenocarcinoma) who received first-line immunization combined with standard chemotherapy (RECIST 1.1 criteria) and were treated with fruquintinib（4mg orally, once daily for 3 wks on/1 wk off ）combined with PD-1 antibody. Until the investigator assesses loss of clinical benefit, unacceptable toxicity, decision by the investigator or subject to withdraw treatment, or death, whichever comes first.\n\nPD-1: Nivolumab(360mg IV d1, Q3W）；Sintilimab(200mg IV d1, Q3W）；Tislelizumab(200mg IV d1, Q3W） can be selected;', 'armGroupLabels': ['Experimental']}] | PrimaryOutcomes: [{'measure': 'Progression free survival (PFS)', 'description': 'Tumor assessment will be performed using radiography method every 8 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1', 'timeFrame': 'from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year'}] | SecondaryOutcomes: [{'measure': 'Overall survival (OS)', 'description': 'Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1', 'timeFrame': 'from randomization until death due to any cause, assessed up to 3 year'}, {'measure': 'Objective response rate (ORR)', 'description': 'Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1', 'timeFrame': 'from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year'}, {'measure': 'Disease control rate (DCR)', 'description': 'Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1', 'timeFrame': 'from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year'}, {'measure': 'Safety and tolerance evaluated by incidence, severity and outcomes of AEs', 'description': 'Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 5.0', 'timeFrame': 'from first dose to 30 days post the last dose'}]
Title: Efficacy and Safety of Acupuncture for Relieving Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer | Condition: Breast Cancer, Stiffness of Hand, Not Elsewhere Classified | Keywords: Breast cancer, Stiffness, Aromatase inhibitor, Acupuncture, High altitude | Summary: | Description: Objectives of this study: Primary objective: To evaluate whether acupuncture as a non-pharmacological treatment, administered twice weekly for 6 weeks can significantly reduce joint stiffness related to AIs in women with early-stage breast cancer as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) stiffness score at weeks 6. Secondary objectives: To evaluate the effect of acupuncture on joint stiffness measured by the WOMAC stiffness score at weeks 12. To evaluate the effect of acupuncture on joint stiffness measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH) stiffness score at weeks 6 and weeks 12. To evaluate the effects of acupuncture on quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES) at weeks 6 and weeks 12. To evaluate the safety and tolerability of acupuncture in the enrolled patients. To identify potential genetic determinants to response to acupuncture. | ArmGroups: [{'label': 'Patients with stiffness of joint receive acupuncture therapy', 'type': 'EXPERIMENTAL', 'description': 'This is a single arm study. All the enrolled patients will receive acupuncture twice weekly for 6 weeks then once weekly for another 6 weeks.', 'interventionNames': ['Device: Acupuncture']}] | Interventions:[{'type': 'DEVICE', 'name': 'Acupuncture', 'description': 'Patients with stiffness of joint receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.', 'armGroupLabels': ['Patients with stiffness of joint receive acupuncture therapy']}] | PrimaryOutcomes: [{'measure': 'The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC)', 'description': 'The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) at the end of week 6 of intervention compared to that at baseline.', 'timeFrame': '6 weeks'}] | SecondaryOutcomes: [{'measure': 'The change in stiffness score as measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH)', 'description': 'The change in stiffness score as measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH) at the end of week 6 of intervention compared to that at baseline.', 'timeFrame': '6 weeks'}]
Title: Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea | Condition: Urothelial Cancer | Keywords: Urothelial Cancer, Bladder Cancer, enfortumab vedotin, PADCEV | Summary: | Description: N/A | ArmGroups: [{'label': 'PADCEV', 'description': 'Patients who receive PADCEV Injection 20 mg and 30 mg (enfortumab vedotin) in routine clinical practice according to the drug label approved at the time of marketing authorization.', 'interventionNames': ['Drug: Enfortumab Vedotin']}] | Interventions:[{'type': 'DRUG', 'name': 'Enfortumab Vedotin', 'description': 'Intravenous', 'armGroupLabels': ['PADCEV'], 'otherNames': ['PADCEV', 'ASG-22CE']}] | PrimaryOutcomes: [{'measure': 'Number of patients with an Adverse Event', 'description': 'Adverse events (AEs) will be summarized using MedDRA. An AE is defined as any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.', 'timeFrame': 'Up to 48 weeks after the first administration of PADCEV'}, {'measure': 'Number of patients with an adverse drug reaction (ADR)', 'description': 'An ADR is defined as any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship is at least a reasonable possibility.', 'timeFrame': 'Up to 48 weeks after the first administration of PADCEV'}, {'measure': 'Number of patients with a serious AE (SAE)', 'description': 'An AE is considered "serious" if it results in death or is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction.', 'timeFrame': 'Up to 48 weeks after the first administration of PADCEV'}, {'measure': 'Number of patients with a serious ADR (SADR)', 'description': 'An ADR is considered "serious" if it results in death or is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction.', 'timeFrame': 'Up to 48 weeks after the first administration of PADCEV'}, {'measure': 'Number of patients with an unexpected AE (UAE)', 'description': 'An UAE is an AE that the nature or severity of which is not consistent with the information in the approved Korean label.', 'timeFrame': 'Up to 48 weeks after the first administration of PADCEV'}, {'measure': 'Number of patients with an unexpected ADR (UADR)', 'description': 'An UADR is defined as an unexpected adverse drug reaction.', 'timeFrame': 'Up to 48 weeks after the first administration of PADCEV'}, {'measure': 'Number of patients with an important risk', 'description': 'An important risk is classified as an important identified risk and an important potential risk.\n\nAn identified risk is defined as the risk that correspond to undesirable clinical outcomes, with sufficient scientific evidence that the undesirable clinical outcome is caused by the drug."Important Identified Risks" are identified risks that have the potential to affect the risk-benefit balance of a product.\n\nAn potential risk is defined as the risk that correspond to undesirable clinical outcomes, with some, but not sufficient, evidence to estimate that the undesirable clinical outcome is caused by the drug."Important Potential Risks" are potential risks that have the potential to affect the risk-benefit balance of a product.', 'timeFrame': 'Up to 48 weeks after the first administration of PADCEV'}] | SecondaryOutcomes: [{'measure': 'Overall survival', 'description': 'Overall survival (OS) is defined as time from start of PADCEV to death.', 'timeFrame': 'Up to 48 weeks after the first administration of PADCEV'}, {'measure': 'Progression free survival', 'description': 'Progression free survival (PFS) is defined as time from start of PADCEV to progressive disease (PD) or death from any cause, whichever occurs first.', 'timeFrame': 'Up to 48 weeks after the first administration of PADCEV'}]
Title: A Phase 1, Open-Label, Dose Escalation Study of the Safety and Preliminary Efficacy of EGEN-001 in Combination With Carboplatin and Docetaxel in Women With Recurrent, Platinum-Sensitive, Epithelial Ovarian Cancer | Condition: Ovarian Neoplasms | Keywords: | Summary: | Description: This study has two purposes: * To determine what different strengths and number of doses of EGEN-001, administered directly into the peritoneal cavity, can be given safely in combination with standard intravenous chemotherapy for ovarian cancer * To evaluate the anti-cancer activity of EGEN-001 when combined with standard chemotherapy; biological markers of EGEN-001 activity will be collected and ovarian cancer burden will be evaluated per standard practice. | ArmGroups: [{'label': 'EGEN-001', 'type': 'EXPERIMENTAL', 'interventionNames': ['Genetic: EGEN-001 (phIL-12-005/PPC)']}] | Interventions:[{'type': 'GENETIC', 'name': 'EGEN-001 (phIL-12-005/PPC)', 'description': 'In stage 1, patients will receive standard doses of IV carboplatin and docetaxel for 2 treatment cycles with a 3 week interval. Patients will also receive 4 IP infusions of EGEN-001 at 12mg/m2 EGEN-001, 18mg/m2, or 24mg/m2, 10-11 days apart.\n\nStage 2 of the study will involve cycle escalation at the highest EGEN-001 dose identified from Stage 1. All patients will receive up to 8 doses of EGEN-001, 10-11 days apart plus up to 4 IV carboplatin and docetaxel cycles with 3 week intervals. After receiving the assigned number of treatments of EGEN-001, carboplatin, and docetaxel, patients may continue to receive up to 4 additional infusions of EGEN-001 and 2 IV carboplatin and docetaxel cycles with 3 week intervals.', 'armGroupLabels': ['EGEN-001']}] | PrimaryOutcomes: [{'measure': 'Determine the MTD and treatment-related toxicities of intra-peritoneal (IP) infusion of EGEN-001 in combination with carboplatin and docetaxel for recurrent, platinum-sensitive, ovarian cancer.', 'timeFrame': '12-14 months'}] | SecondaryOutcomes: [{'measure': "Examine the optimal EGEN-001 treatment regimen in combination with carboplatin and docetaxel in recurrent, platinum-sensitive ovarian cancer, and assess EGEN-001's impact on tumor, CA-125, and activity markers of biological activity.", 'timeFrame': '10 months'}]