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Title: The Pacific Clinical Trial: A Randomized Phase II Study Evaluating OGX-427 in Patients With Metastatic Castrate-Resistant Prostate Cancer (MCRPC)Who Have Prostate-Specific Antigen (PSA) Progression While Receiving Abiraterone: Hoosier Oncology Group GU12-159 | Condition: Prostate Cancer, Metastatic Castrate-Resistant Prostate Cancer, PSA | Keywords: OGX-427, Abiraterone Acetate | Summary: | Description: OUTLINE: This is a multi-center study.
This is an open-label, randomized, Phase II clinical trial designed to evaluate the anti-tumor effects of OGX-427 and continuing abiraterone acetate and prednisone versus continuing abiraterone acetate and prednisone alone in men with MCRPC who have evidence of PSA progression but no evidence of symptomatic or radiographic progression that would require alternative therapy (e.g., needing radiation therapy for pain or significant progression of visceral metastases).
Patients on the control arm will be allowed to cross-over to receive OGX-427 following documented disease progression. Patients will be randomized with equal probability to one of the following arms:
EXPERIMENTAL ARM (Arm A):
OGX-427 Starting within 7 days of randomization, three loading doses of 600 mg intravenously (IV) within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV
Continuation of standard therapy with abiraterone acetate 1000 mg by mouth (PO) daily and prednisone 10-20 mg PO daily
CONTROL ARM (Arm B):
Continuation of standard therapy with abiraterone acetate 1000 mg PO daily and prednisone 10-20 mg PO daily
After documented disease progression, patients on Arm B may opt to receive OGX-427 treatment (according to the Arm A schedule) following a screening evaluation (i.e., all inclusion and exclusion criteria have been met)
Both Arms:
Evaluations at 4 week-intervals. Disease assessments required at the milestone Day 60 assessment (expected to occur after 8 weeks of treatment and prior to Day 1, Week 9) and at 16, 24, 32, 40, and 48 weeks (if applicable) or until documented disease progression. Patients who are withdrawn from the study for a reason other than documented disease progression or patient withdrawal of consent will be followed every 4 weeks in the Off-Treatment Follow-up Period until documented disease progression.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life Expectancy: Not Specified
Hematopoietic:
* Absolute neutrophil count (ANC) ≥ 1.5 x 109 cells /L, platelet count ≥ 100 x 109 /L, and hemoglobin ≥ 9 g/dL without transfusion
Hepatic:
* Total bilirubin ≤ 1.1 x upper limit of normal (ULN) unless elevated secondary to conditions such as Gilbert's disease, in which case a direct bilirubin ≤ ULN is required
* Serum glutamic pyruvic transaminase (SGPT), alanine transaminase (ALT) and alanine transaminase (SGOT) aspartate transaminase (AST) ≤ 3.0 x ULN
Renal:
* Creatinine ≤ 1.3 x ULN
Cardiac:
* Known left ventricular ejection fraction (LVEF) \<50% or New York Heart Association (NYHA) Functional Classification Class III or IV heart failure
Other:
* Castrate serum testosterone level (\< 50 ng/dL or \< 1.7 nmol/L)
* Potassium within normal limits | ArmGroups: [{'label': 'Experimental: Arm A', 'type': 'EXPERIMENTAL', 'description': 'OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone', 'interventionNames': ['Drug: OGX-427', 'Drug: Abiraterone Acetate', 'Drug: Prednisone']}, {'label': 'Control Arm: Arm B', 'type': 'ACTIVE_COMPARATOR', 'description': 'Continuation of standard therapy with abiraterone acetate and prednisone', 'interventionNames': ['Drug: Abiraterone Acetate', 'Drug: Prednisone']}] | Interventions:[{'type': 'DRUG', 'name': 'OGX-427', 'description': 'OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV', 'armGroupLabels': ['Experimental: Arm A']}, {'type': 'DRUG', 'name': 'Abiraterone Acetate', 'description': 'Standard therapy: Abiraterone Acetate 1000 mg PO daily', 'armGroupLabels': ['Control Arm: Arm B', 'Experimental: Arm A']}, {'type': 'DRUG', 'name': 'Prednisone', 'description': 'Standard therapy: Prednisone 10-20 mg PO daily', 'armGroupLabels': ['Control Arm: Arm B', 'Experimental: Arm A']}] | PrimaryOutcomes: [{'measure': 'Progression-Free Survival', 'description': 'To ascertain whether Arm A has a greater proportion of patients observed to be alive without progression at Day 60 (±7 days) as compared to Arm B.', 'timeFrame': '60 days'}] | SecondaryOutcomes: [{'measure': 'PSA Response', 'description': 'Compare arms to determine the proportion of patients who have a PSA response (≥ 30% decline) and any PSA decline post-randomization.', 'timeFrame': '60 days'}] |
Title: Neoadjuvant Anthracycline Followed by Toripalimab Combined With Nab-paclitaxel in Patients With Early Triple-negative Breast Cancer | Condition: Triple Negative Breast Cancer | Keywords: Programmed Death-1 | Summary: | Description: This study is an open single arm study, which would undergo optimal two stage designs. 60 patients who are diagnosed with triple-negative breast cancer would have dose-dense epirubicin hydrochloride with cyclophosphamide followed by nanoparticlealbumin-bound paclitaxel with PD-1 regimen for neoadjuvant therapy if they meet the eligibility criteria. The regimen is as follows: epirubicin hydrochloride (90mg/m2, d1) plus cyclophosphamide (600mg/m2, d1) every 14 days as one cycle for 4 cycles, followed by nanoparticlealbumin-bound paclitaxel (125mg/m2, d1) per week for 3 weeks as one cycle for 4 cycles, and Toripalimab (240mg, d1) every 3 weeks as one cycle for 4 cycles. pathological complete response would be the primary endpoint. The change of biological markers and safety of the regimen would also be evaluated. | ArmGroups: [{'label': 'EC-ABX/PD-1', 'type': 'EXPERIMENTAL', 'description': 'Patients who are treated with epirubicin hydrochloride andcyclophosphamide followed by nanoparticlealbumin-bound paclitaxel and Toripalimab', 'interventionNames': ['Drug: epirubicin hydrochloride', 'Drug: Cyclophosphamide', 'Drug: Albumin bound paclitaxel', 'Drug: Toripalimab']}] | Interventions:[{'type': 'DRUG', 'name': 'epirubicin hydrochloride', 'description': 'Take epirubicin hydrochloride (90mg/m2, d1) every 14 days as one cycle for 4 cycles with cyclophosphamide, followed by nanoparticlealbumin-bound paclitaxel and Toripalimab.', 'armGroupLabels': ['EC-ABX/PD-1']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'Take cyclophosphamide (600mg/m2, d1) every 14 days as one cycle for 4 cycles with epirubicin hydrochloride, followed by nanoparticlealbumin-bound paclitaxel and Toripalimab.', 'armGroupLabels': ['EC-ABX/PD-1']}, {'type': 'DRUG', 'name': 'Albumin bound paclitaxel', 'description': 'Take nanoparticlealbumin-bound paclitaxel (125mg/m2, d1) per week for 3 weeks as one cycle for 4 cycles with Toripalimab, following epirubicin hydrochloride and cyclophosphamide.', 'armGroupLabels': ['EC-ABX/PD-1']}, {'type': 'DRUG', 'name': 'Toripalimab', 'description': 'Take Toripalimab (240mg, d1) every 3 weeks as one cycle for 4 cycles with nanoparticlealbumin-bound paclitaxel, following epirubicin hydrochloride and cyclophosphamide.', 'armGroupLabels': ['EC-ABX/PD-1']}] | PrimaryOutcomes: [{'measure': 'Total Pathologic complete response (tpCR)', 'description': 'Defined as no residual invasive cancer cells are found in the pathological examination of breast and axillary lymph node; if only residual in situ cancer cells are present in the surgical specimens, it can also be considered as achieving a pathological complete response.', 'timeFrame': 'Immediately after the surgery'}] | SecondaryOutcomes: [{'measure': 'Breast pathologic complete response (bpCR: ypT0/is) rate', 'description': 'Defined as the absence of invasive cancer cells in breast.', 'timeFrame': 'Immediately after the surgery'}, {'measure': 'Objective response rate (ORR)', 'description': 'Defined as the proportion of patients with a complete or partial response by MRI.', 'timeFrame': 'Immediately after the surgery'}, {'measure': 'Breast conservative surgery rate', 'description': 'Defined as the percentage of patients who undergo breast-conserving surgery after neoadjuvant therapy, out of the total number of evaluable cases.', 'timeFrame': 'Immediately after the surgery'}, {'measure': 'Event-free survival (EFS)', 'description': 'Defined as the time from the date of the first study dose to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.', 'timeFrame': 'Approximately 3 years'}, {'measure': 'Adverse events (AEs)', 'description': 'Refer to any untoward medical occurrence in a study subject administered an investigational product which does not necessarily have a causal relationship with the treatment. AE is assessed according to the NCI-CTCAE 5.0.', 'timeFrame': 'During this period between the start of randomization and the last visit, approximately 3 years'}, {'measure': 'Change in immune-related tissue biomarkers', 'description': 'The proportion of Tumor-infiltrating lymphocytes (TILs) is evaluated through HE staining. Immunohistochemical staining of PD-1, PD-L1, AR, CD8, and FOXC1) is performed. TILs, PD1, PD-L1, AR, CD8, and FOXC1 in tumor samples by biopsy at baseline, at the end of Cycle 2 and by surgery immediately after surgery would be evaluated by HE or immune staining.', 'timeFrame': 'At baseline, at the end of first 2 cycles (each cycle is 14 days) and immediately after the surgery'}] |
Title: Randomized Phase II/III Trial of Radiotherapy With Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy With Concurrent Cetuximab in Patients With Locoregionally Advanced Head and Neck Cancer With a Contraindication to Cisplatin | Condition: Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Squamous Cell Carcinoma of Unknown Primary, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVB Hypopharyngeal Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Lip and Oral Cavity Cancer AJCC v8, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8 | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. To determine the safety of radiotherapy (RT) with concurrent and adjuvant anti-PD-L1 therapy (MEDI4736 \[durvalumab\]) is safe in patients with locoregionally advanced head and neck cancer (HNC) who have a contraindication to cisplatin. (Lead-in) II. To test the hypothesis that concurrent RT and anti-PD-L1 therapy improves progression free survival (PFS) compared to standard therapy (RT with concurrent cetuximab) in patients with locoregionally advanced HNC who have a contraindication to cisplatin. (Phase II) III. To test the hypothesis that concurrent RT and anti-PD-L1 therapy improves overall survival compared to standard therapy (RT with concurrent cetuximab) in patients with locoregionally advanced HNC who have a contraindication to cisplatin. (Phase III)
SECONDARY OBJECTIVES:
I. To compare toxicity using Common Terminology Criteria for Adverse Events (CTCAE) and Patient Reported Outcomes (PRO)-CTCAE between patients treated with RT + anti-PD-L1 therapy versus RT/cetuximab.
II. To test the effect of anti-PD-L1 therapy in the subpopulation of patients with tumors that overexpress PD-L1.
III. To compare overall survival, response (at 4-month fludeoxyglucose F-18 \[FDG\]-positron emission tomography \[PET\]-computed tomography \[CT\]), locoregional failure, distant metastasis, and competing mortality in the two arms by known risk factors, including p16 status and omega score.
IV. To test the hypothesis that MEDI4736 (durvalumab) therapy arm will have less decline in the physical function domain of European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30 version 3.0) based on the change in score from baseline to 12 months from end of RT, compared to the cetuximab-RT arm in patients with locoregionally advanced HNC who have a contraindication to cisplatin.
V. To test the hypothesis that MEDI4736 (durvalumab) therapy arm at 1 year (from end of RT) will have less decline in swallowing related quality of life (QOL) using the M. D. Anderson Dysphagia Inventory (MDADI) total composite score, based on the change in score from baseline to 12 months from end of RT, compared to the cetuximab-RT arm in patients who are medically unfit for cisplatin.
VI. To compare swallowing related performance and function short and long term using the Performance Status Scale for Head \& Neck Cancer Patients (PSS-HN).
VII. To evaluate gastrostomy tube retention rates between arms.
EXPLORATORY OBJECTIVES:
I. To test the hypothesis that radiation combined with MEDI4736 (durvalumab) enhances the adaptive immune response using three types of immunophenotyping compared to radiation combined with cetuximab.
II. To compare overall QOL short term (end RT-8 months) and long term (12-24 months from end of RT) between arms using the EORTC QLQ-C30 version 3.0/HN35.
III. To evaluate swallowing related QOL short term (end RT-8 months) and long term (12-24 months from end of RT) using the EORTC Head and Neck (HN)35 swallowing domain and MDADI (subscales) between arms in patients with locoregionally advanced HNC who have a contraindication to cisplatin.
IV. To evaluate patient reported fatigue using the fatigue items in the EORTC QLQ and PRO-CTCAE.
V. To compare clinician and patient reported toxicity using CTCAE and PRO CTCAE.
VI. To explore health utilities between cetuximab and MEDI4736 (durvalumab) RT using the European Quality of Life 5 Dimensional-5 Level (EQ5D-5L).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive cetuximab intravenously (IV) weekly over 60-120 minutes. Treatment repeats every week for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Beginning 5-7 days after first cetuximab dose, patients undergo intensity modulated radiation therapy (IMRT) 5 fractions per week for up to 7 weeks.
ARM II: Patients receive durvalumab IV over 60 minutes every 4 weeks. Treatment repeats every 4 weeks for up to 7 cycles in the absence of disease progression or unacceptable toxicity. Beginning week 2, patients undergo IMRT 5 fractions per week for up to 7 weeks.
After completion of study treatment, patients are followed up at 1 month, every 4 months for 1 year, every 6 months for 2 years, then annually thereafter. | ArmGroups: [{'label': 'Arm I (cetuximab, radiation therapy)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients receive cetuximab IV weekly over 60-120 minutes. Treatment repeats every week for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Beginning 5-7 days after first cetuximab dose, patients undergo IMRT 5 fractions per week for up to 7 weeks.', 'interventionNames': ['Biological: Cetuximab', 'Radiation: Intensity-Modulated Radiation Therapy', 'Other: Laboratory Biomarker Analysis', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'label': 'Arm II (durvalumab, radiation therapy)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive durvalumab IV over 60 minutes every 4 weeks. Treatment repeats every 4 weeks for up to 7 cycles in the absence of disease progression or unacceptable toxicity. Beginning week 2, patients undergo IMRT 5 fractions per week for up to 7 weeks.', 'interventionNames': ['Biological: Durvalumab', 'Radiation: Intensity-Modulated Radiation Therapy', 'Other: Laboratory Biomarker Analysis', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'Cetuximab', 'description': 'Given IV', 'armGroupLabels': ['Arm I (cetuximab, radiation therapy)'], 'otherNames': ['C 225', 'C-225', 'C225', 'Cetuximab Biosimilar CDP-1', 'Cetuximab Biosimilar CMAB009', 'Cetuximab Biosimilar KL 140', 'Chimeric Anti-EGFR Monoclonal Antibody', 'Chimeric MoAb C225', 'Chimeric Monoclonal Antibody C225', 'Erbitux', 'IMC-C225']}, {'type': 'BIOLOGICAL', 'name': 'Durvalumab', 'description': 'Given IV', 'armGroupLabels': ['Arm II (durvalumab, radiation therapy)'], 'otherNames': ['Imfinzi', 'Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer', 'MEDI 4736', 'MEDI-4736', 'MEDI4736']}, {'type': 'RADIATION', 'name': 'Intensity-Modulated Radiation Therapy', 'description': 'Undergo IMRT', 'armGroupLabels': ['Arm I (cetuximab, radiation therapy)', 'Arm II (durvalumab, radiation therapy)'], 'otherNames': ['IMRT', 'Intensity modulated radiation therapy (procedure)', 'Intensity Modulated RT', 'Intensity-Modulated Radiotherapy', 'Radiation, Intensity-Modulated Radiotherapy']}, {'type': 'OTHER', 'name': 'Laboratory Biomarker Analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (cetuximab, radiation therapy)', 'Arm II (durvalumab, radiation therapy)']}, {'type': 'OTHER', 'name': 'Quality-of-Life Assessment', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (cetuximab, radiation therapy)', 'Arm II (durvalumab, radiation therapy)'], 'otherNames': ['Quality of Life Assessment']}, {'type': 'OTHER', 'name': 'Questionnaire Administration', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (cetuximab, radiation therapy)', 'Arm II (durvalumab, radiation therapy)']}] | PrimaryOutcomes: [{'measure': '(Lead-in) Number of Participants With Dose-limiting Toxicity (DLT)', 'description': 'DLTs were collected to verify the safety of durvalumab with RT in this population. Safety was determined if ≤ 2 of 8 participants in the cohort had any DLT, in which case the study would proceed to phase II with that dose schedule (DS). The probability for the DS to be deemed too toxic, given a true toxicity rate ≥ 45%, is at least 78%. With a true toxicity rate ≤ 20%, the probability for the DS do be deemed safe is 80%. The full DLT definition does not fit here, but includes all grade 5 AEs, grade 3 or 4 AEs definitely or probably related to durvalumab (DPRD) except for specified AEs and situations, and incomplete or \\> 2-week delay completing RT due to immune toxicity DPRD. AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, which grade severity from 1=mild to 5=death. Two alternate DSs with a delayed 2nd dose (to reduce/avoid doses concurrent with RT) would be tried if the initial DS was too toxic.', 'timeFrame': 'From start of durvalumab to 4 weeks after radiation therapy, approximately 13 weeks. Weekly during RT, at RT end, prior to adjuvant durvalumab, one month after end of RT.'}, {'measure': 'Progression-free Survival (Percentage of Participants Alive Without Progression)', 'description': 'Progression (failure) is defined as local, regional, or distant disease progression, or death from any cause. Progression was assessed by imaging, clinical assessment, or biopsy.\n\nFailure time is defined as time from randomization to failure or last follow-up (censored). Failure rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided. Analysis was planned to occur after 69 failure events had been reported.', 'timeFrame': 'From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years.'}, {'measure': 'Overall Survival (Percentage of Participants Alive)', 'description': 'Overall survival (OS) time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided.', 'timeFrame': 'From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years.'}] | SecondaryOutcomes: [{'measure': 'Locoregional Failure (Percentage of Participants With Locoregional Failure)', 'description': 'Locoregional progression is defined as local or regional progression or recurrence, death due to study cancer or unknown causes without documented progression. Progression was assessed by imaging, clinical assessment, or biopsy. Failure time is defined as time from randomization to failure, distant metastasis (competing risk), deaths from other causes (competing risk), or last follow-up (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided.', 'timeFrame': 'From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years.'}, {'measure': 'Distant Metastasis (Percentage of Participants With Distant Metastasis)', 'description': 'Failure is defined as the occurrence of distant metastasis. Failure time is defined as time from randomization to first occurrence of distant metastasis, local or regional progression or recurrence (competing risk), death (competing risk), or last follow-up (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided.', 'timeFrame': 'From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years.'}, {'measure': 'Competing Mortality (Percentage of Participants Who Died Due to Causes Other Than Study Cancer)', 'description': 'Failure is defined as Death from second primary, protocol treatment, or "other cause". Failure time is defined as time from randomization to first occurrence of failure, death due to study cancer or unknown cause (competing risk), or last follow-up (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided.', 'timeFrame': 'From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years.'}, {'measure': 'Percentage of Participants With Complete or Partial Response at 4-month Scan Determined by Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1', 'description': 'Fludeoxyglucose F-18 positron emission tomography/computed tomography (FDG-PET/CT) scans at baseline and four months after the end of radiation therapy are compared.\n\nPer RECIST 1.1:\n\n* Complete response:\n\n * Disappearance of all lesions and pathologic lymph nodes\n* Partial response:\n\n * ≥ 30% decrease sum of the longest diameters\n * No new lesions\n * No progression of non-target lesions', 'timeFrame': 'Baseline and 4 months after end of RT (approximately 6.5 months)'}, {'measure': 'Number of Participants by Highest Grade Adverse Event Reported', 'description': 'Common Terminology Criteria for Adverse Events (version 5.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.', 'timeFrame': 'From randomization to last follow-up: weekly during RT, RT end, from end of RT: months 1, (Cetuximab: 2, 3,) 4, 8, 12, 18, 24, 30, 36, then annually. Additionally, prior to each adjuvant durvalumab cycle. Maximum follow-up at time of analysis= 4.2 yr.'}, {'measure': 'Change in Quality of Life (QOL) Analysis', 'description': 'Assessed using European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ)/Head-and-Neck module (H\\&N35), EuroQol- 5 Dimension (EQ5D), M. D. Anderson Dysphagia Inventory (MDADI), patient reported outcomes (PRO)-CTCAE, geriatric screening (G8). The mean summary score of the EORTC QLQ/H\\&N35, EQ5D, MDADI, PRO-CTCAE, G8, CCI, and the subscales will be determined. The mean change from baseline at each time point will be summarized using mean and standard deviations for each arm. Mean change from baseline will be compared between the arms using a two sample t test. If data normality assumptions are not met, the Wilcoxon rank sum test will be used to test the hypothesis. Mean change from baseline will be tested using an omnibus F test followed by individual comparisons of change scores at different time points within each treatment group. The same analysis will be conducted for between group comparisons at each time point.', 'timeFrame': 'Baseline up to 12 months'}, {'measure': 'Change in Swallowing QOL Using Total Composite M. D. Anderson Dysphagia Inventory (MDADI) Score', 'description': 'The mean change from baseline at each time point will be summarized using mean and standard deviations for each arm. Mean change from baseline will be compared between the arms using a two sample t test. If data normality assumptions are not met, the Wilcoxon rank sum test will be used to test the hypothesis.', 'timeFrame': 'Baseline up to 1 year'}, {'measure': 'Translational Research, Including PD-L1 and p16', 'description': 'Analyses of interaction between treatment arm and marker status will be done. Additionally toxicity for the two arms by marker status will be compared. Univariable and multivariable analysis will be performed using the Cox proportional hazards model for overall survival. Potential covariates evaluated for the multivariate models would be assigned treatment, age, Zubrod performance status, T-stage, N-stage, primary site, smoking history, other risk factors, as well as p16 and/PD-L1.', 'timeFrame': 'Up to 3 years'}] |
Title: Metabolic Genotypes and Oncogenic Damage in Breast Cancer | Condition: Breast Cancer | Keywords: breast cancer | Summary: | Description: OBJECTIVES:
* To determine the association between the genotype for 4 metabolic enzymes (e.g., CYP1A1, GSTM, GSTT, and GSTP) in women with newly diagnosed breast cancer that play key roles in the metabolism of environmental human carcinogens and the risk of breast cancer development.
OUTLINE: Urine and blood samples are collected for DNA, mutation, and polymorphism analysis. The biological samples may be stored and used for future research.
Patients complete a Baseline Questionnaire to collect basic risk/exposure information, including demographic factors (e.g., age, weight, height, and body mass index), menstrual/reproductive history, medical history, medication use, smoking history, alcohol consumption, exposure to chest x-ray, and family history of breast cancer in first-degree relatives. Patients also complete a Second Hand Smoke Questionnaire to collect information on cigarette smoking history and second hand smoke exposure and a Food Frequency Questionnaire to collect information on the frequency of use of specific fruits and vegetables (e.g., cruciferous vegetables) and to estimate usual dietary intake of 33 nutrients during the past year (e.g., total fat, saturated fat, oleic fat, linoleic fat, carbohydrates, protein, vitamins \[e.g., A, B1, B2, niacin, B6, folate, C, and E\], minerals \[e.g., calcium, magnesium, iron, and zinc\], electrolytes \[e.g., sodium and potassium\], and dietary fiber). Patients' medical charts are also reviewed to collect information on age, gender, ethnic background, medical history, and medical care. | ArmGroups: N/A | Interventions:[{'type': 'GENETIC', 'name': 'DNA analysis'}, {'type': 'GENETIC', 'name': 'mutation analysis'}, {'type': 'GENETIC', 'name': 'polymorphism analysis'}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis'}, {'type': 'OTHER', 'name': 'medical chart review'}, {'type': 'OTHER', 'name': 'questionnaire administration'}, {'type': 'PROCEDURE', 'name': 'evaluation of cancer risk factors'}] | PrimaryOutcomes: [{'measure': 'Association between the genotype for 4 metabolic enzymes (e.g., CYP1A1, GSTM, GSTT, and GSTP) that play key roles in the metabolism of environmental human carcinogens and the risk of breast cancer development', 'timeFrame': 'Day 1'}] | SecondaryOutcomes: N/A |
Title: A Phase I Trial of an Immune Checkpoint Inhibitor Plus Stereotactic Ablative Radiotherapy in Patients With Inoperable Stage I Non-Small Cell Lung Cancer | Condition: Stage I Non-Small Cell Lung Cancer | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of MPDL3280A (atezolizumab) that can be given with stereotactic ablative radiotherapy (SAR) (stereotactic body radiation therapy) in patients with inoperable stage I non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
I. To characterize the safety profile of this regimen using CTCAE v4 (Common Toxicity Criteria for Adverse Events version 4).
II. To provide preliminary efficacy data of the combination as determine by objective response rate and disease free survival using RECIST 1.1 (Response Evaluation Criteria for Solid Tumors) and Immune Related RECIST (irRECIST).
TERTIARY OBJECTIVES:
I. To analyze serial blood for change in cytokine signatures, fluorescence activated cell sorting (FACS) and immunophenotyping of peripheral blood mononuclear cells (PBMCs) and tumor infiltrating immune cells.
II. To evaluate pre and post treatment tumor tissue (if available) for programmed cell death-ligand 1 (PD-L1) and other immune proteins in the tumor and tumor microenvironment and for molecular profiling in a subset of patient samples.
III. To discover biomarkers of response from the data obtained.
OUTLINE: This is a dose-escalation study of atezolizumab.
DOSE ESCALATION PHASE: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Within 24-48 hours after receiving atezolizumab, patients also undergo 4-5 fractions of stereotactic body radiation therapy over days 1-5 of course 3.
EXPANSION PHASE: Patients receive atezolizumab IV over 30-60 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Within 24-48 hours after receiving atezolizumab, patients also undergo 4-5 fractions of stereotactic body radiation therapy over days 1-5 of course 3.
After completion of study treatment, patients are followed up at 30 days, every 3 months for 2 years, and then every 6 months for 3 years. | ArmGroups: [{'label': 'atezolizumab + SBRT', 'type': 'EXPERIMENTAL', 'description': 'DOSE ESCALATION PHASE: Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Within 24-48 hours after receiving atezolizumab, patients also undergo 4-5 fractions of stereotactic body radiation therapy over days 1-5 of course 3.\n\nEXPANSION PHASE: Patients receive atezolizumab IV over 30-60 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Within 24-48 hours after receiving atezolizumab, patients also undergo 4-5 fractions of stereotactic body radiation therapy over days 1-5 of course 3.', 'interventionNames': ['Drug: Atezolizumab', 'Radiation: Stereotactic Body Radiation Therapy']}] | Interventions:[{'type': 'DRUG', 'name': 'Atezolizumab', 'description': 'Into the vein Day 1 every 3 weeks for 6 cycles', 'armGroupLabels': ['atezolizumab + SBRT'], 'otherNames': ['MPDL3280A']}, {'type': 'RADIATION', 'name': 'Stereotactic Body Radiation Therapy', 'description': 'Radiation therapy will be performed to 50 Gy over 4 fractions of 12/5 Gy each for peripherally located tumors and 50 Gy over 5 fractions of 10 Gy each for centrally located tumors', 'armGroupLabels': ['atezolizumab + SBRT'], 'otherNames': ['SBRT']}] | PrimaryOutcomes: [{'measure': 'Maximum Tolerated Dose', 'description': 'The adverse events will be summarized as frequency, proportion of patients MTD. The exact 95% confidence interval for proportion will be categorized by type, severity, nadir or maximum values for the laboratory measures, time of onset, duration, and reversibility or outcome. Tables will be created to summarize these toxicities by dose and course.', 'timeFrame': '9 weeks'}] | SecondaryOutcomes: [{'measure': 'Disease free survival (DFS), assessed by RECIST 1.1 and irRECIST', 'description': 'DFS will be summarized with Kaplan-Meier plots. The median DFS time will be estimated using standard life table methods.', 'timeFrame': 'Up to 5 years'}, {'measure': 'Overall response rate (ORR), assessed by RECIST 1.1', 'description': 'ORR will be summarized by exact binomial confidence intervals.', 'timeFrame': 'Time from the start of the treatment until disease progression/recurrence, assessed up to 5 years'}] |
Title: Phase I Study to Assess the Tolerability and Efficacy of Nivolumab as Single Agent to Eliminate Minimal Residual Disease and Maintain Remission in Patients With Hematologic Malignancies After Allogeneic Stem Cell Transplantation | Condition: Hematologic Malignancies | Keywords: hematologic malignancies, allogeneic stem cell transplantation (allo-SCT) | Summary: | Description: Nivolumab will be administrated intravenously. Standard dose escalation will be used for the intensification phase with starting dose at 1m/kg every 2 weeks for 4 doses. The DLT observation period is 29 days starting with the first dose taken on Day 1, The study treatment will continue until one of the discontinuation criteria is met. Each dose level (1-2) will be tested using the 3+3 design. If level 2 of 3mg/kg is reached without DLTs, 3mg/kg will be used for the dose expansion cohort. After the intensification phase, patients will start Nivolumab every 12 weeks maintenance phase till 2 years post allo-SCT. Patients will also receive best supportive care (BSC), including blood product transfusions, antimicrobials, and (as appropriate) granulocyte colony stimulating factors for neutropenic infection or poor graft function. | ArmGroups: [{'label': 'Nivolumab', 'type': 'EXPERIMENTAL', 'description': 'Nivolumab will be administrated intravenously. Standard dose escalation will be used for the intensification phase with starting dose at 1m/kg every 2 weeks for 4 doses.', 'interventionNames': ['Drug: Nivolumab']}] | Interventions:[{'type': 'DRUG', 'name': 'Nivolumab', 'description': 'Nivolumab dose escalation will be used for the intensification phase with starting dose at 1m/kg every 2 weeks for 4 doses.', 'armGroupLabels': ['Nivolumab'], 'otherNames': ['Opdivo']}] | PrimaryOutcomes: [{'measure': 'Maximum tolerated dose of Nivolumab', 'description': 'The maximum tolerated dose (MTD) of Nivolumab in patients with hematologic malignancies after allo-SCT.', 'timeFrame': '24 months'}] | SecondaryOutcomes: [{'measure': 'Number of type of adverse events', 'description': 'To evaluate the toxicities of Nivolumab as maintenance treatment after allogeneic stem cell transplantation (allo-SCT).', 'timeFrame': '24 months'}, {'measure': 'Incidence of non-relapse mortality', 'timeFrame': 'From the date of therapy to the date of non-relapse death, whichever came first, assessed up to 100 months'}, {'measure': 'Time until progression free survival', 'timeFrame': 'From start date of therapy to the first documented disease relapse or death from any cause, whichever may come first, assessed up to 100 months'}, {'measure': 'Time until overall survival', 'timeFrame': 'From start date of therapy to death from any cause, whichever may come first, assessed up to 100 months'}] |
Title: French Biological Observatory on Lung Cancer in Never Smokers | Condition: Lung Cancer | Keywords: lung cancer, smoking, molecular epidemiology, genetic polymorphism, risk factors, never smokers, histologically/cytologically confirmed, IFCT | Summary: | Description: According to WHO, 25% of lung cancer worldwide occurs in lifelong never smokers. Lung cancer in never smokers (LCINS) shows many clinical, epidemiological, molecular and genomic differences comparing to tobacco-related neoplasm. So, it is now considered as a separate entity. LCINS particularly occurs in women and Asian. They are mainly adenocarcinoma. Known risk factors are occupational exposure, environmental tobacco smoking, familial history of cancer, personal medical history of lung disease or environmental causes. LCINS carries more frequently molecular abnormalities leading to efficacy of targeted therapies (EGFR mutation, EML4-ALK inversion, less frequent mutations of KRAS ...). However, most data come from retrospectives studies, subgroups analysis and/or from Asian cohort even though it is a disease with a significant geographic variability. Finally, few studies focus on correlations between risk factors and molecular or genomic abnormalities.
For these reasons and considering that LCINS is an increasing public health problem, IFCT (Intergroupe Francophone de Cancérologie Thoracique) states to promote the BioCAST study (IFCT-1002). It is a national, multicentric, prospective epidemiological study. Main objective is to describe the clinical and molecular epidemiology of LCINS in a French population composed by all cases newly diagnosed in participating centres (500 to 1500 patients expected). BioCAST include a clinical and a biological part. The clinical component is based on collecting data directly from the patient through a standardized questionnaire during a telephone interview with a health professional. The biologic component includes a blood sample collection. A large genomic wide association study and an epigenetic study (including micro RNA study) are also planned. Other objectives are looking for correlations between clinical factors and molecular abnormalities; and looking for new oncogene in this specific population.
BioCAST hopes to provide concrete answers to clinicians and patients about this new and frequent entity. | ArmGroups: [{'label': 'LCINS', 'description': 'Never smokers with newly diagnosed lung cancer'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Prevalence of EGFR mutations in never smokers with newly diagnosed non-small-cell lung cancer (NSCLC)', 'timeFrame': 'November 2011 to January 2013'}] | SecondaryOutcomes: N/A |
Title: Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer: Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT II) | Condition: Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm | Keywords: | Summary: | Description: I. To determine whether patients treated with a matched targeted therapy selected on the basis of genomic alteration analysis of the tumor have longer progression-free survival (PFS) than those whose treatment is not selected on the basis of alteration analysis. Genomic analysis of tumor sample will be performed at the time of enrollment to identify tumor molecular alterations and to assign treatment for every individual patient.
OUTLINE: After completion of molecular profiling, patients who qualify for the trial will be offered randomization as previously. If they wish to be randomized, patients will be randomized to one of the two arms: matched targeted therapy (ARM I) or other therapy (ARM II). Patients who decline to be randomized will then be offered their choice of the two trial arms.
ARM I: Matched targeted therapy: Molecular profiling results are used to assign targeted therapy. Patients receive targeted therapy by participating in a Phase I or a Phase II clinical trial. If a clinical trial is not available, and a commercially available targeted therapy exists (Food and Drug Administration \[FDA\]-approved for another indication), patients can receive the FDA-approved drug.
ARM II: Other therapy: Patients receive standard of care therapy at the discretion of the treating physician.
Patients with tumor progression who achieve the primary study endpoint can cross over to the other treatment arm. | ArmGroups: [{'label': 'Arm A: Targeted Therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Personalized treatment, targeted therapy against the alteration based on molecular profiling.', 'interventionNames': ['Drug: Targeted Therapy Based on Molecular Profiling']}, {'label': 'Arm B: Standard-of-Care Therapy', 'type': 'EXPERIMENTAL', 'description': 'Standard-of-Care treatment not selected on basis of alteration analysis.', 'interventionNames': ['Drug: Standard-of-Care Therapy']}] | Interventions:[{'type': 'DRUG', 'name': 'Targeted Therapy Based on Molecular Profiling', 'description': 'Molecular profiling results are used to assign targeted therapy. Patients receive targeted therapy by participating in a Phase I or a Phase II clinical trial. If a clinical trial is not available, and a commercially available targeted therapy exists (Food and Drug Administration \\[FDA\\]-approved for another indication), patients can receive the FDA-approved drug.', 'armGroupLabels': ['Arm A: Targeted Therapy']}, {'type': 'DRUG', 'name': 'Standard-of-Care Therapy', 'description': 'Standard-of-care treatment regimen will be left to the discretion of the treating physician.', 'armGroupLabels': ['Arm B: Standard-of-Care Therapy']}] | PrimaryOutcomes: [{'measure': 'Comparison of Progression-Free Survival (PFS) Between the Two Randomized Arms', 'description': 'Progression-free survival (PFS) of patients treated with a targeted therapy selected on the basis of mutational analysis of the tumor compared with PFS of those whose treatment is not selected based on alteration analysis.', 'timeFrame': 'Continuous Monitoring, expected range from 2 months to 3 years'}] | SecondaryOutcomes: N/A |
Title: Phase I Study of Weekly Irinotecan Combined With Amrubicin in Previously Treated Small-Cell Lung Cancer | Condition: Lung Cancer | Keywords: extensive stage small cell lung cancer, recurrent small cell lung cancer | Summary: | Description: OBJECTIVES:
Primary
* Determine the dose-limiting toxicity and maximum tolerated dose of amrubicin when combined with irinotecan in patients with recurrent or relapsed extensive stage small cell lung cancer.
Secondary
* Determine the response rate in patients treated with this regimen.
* Determine the overall survival of patients treated with this regimen.
* Determine the frequency and severity of adverse events in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of amrubicin.
Patients receive amrubicin on day 1 and irinotecan IV on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of up to 6 patients receive escalating doses of amrubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 1/3 (or 33%) of patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 6-30 patients will be accrued for this study. | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'amrubicin hydrochloride'}, {'type': 'DRUG', 'name': 'irinotecan hydrochloride'}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer | Condition: Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. To estimate accrual, retention, adherence, and participation of breast cancer survivors to a breast cancer rehabilitation program.
II. To estimate the variability of weight, six-minute walk, quality of life and other psychosocial and physical measures in women participating in the BCRP.
SECONDARY OBJECTIVES:
I. To assess changes in the anthropometric, psychosocial, and physical outcomes over the six-month period of the BCRP.
II. To document the types and the rates of adverse events associated with the BCRP.
OUTLINE:
Patients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20 minutes of resistance training exercise. | ArmGroups: [{'label': 'Arm I', 'type': 'EXPERIMENTAL', 'description': 'Patients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20 minutes of resistance training exercise.', 'interventionNames': ['Other: questionnaire administration', 'Behavioral: exercise intervention', 'Procedure: quality-of-life assessment', 'Other: survey administration', 'Procedure: management of therapy complications', 'Procedure: psychosocial assessment and care']}] | Interventions:[{'type': 'OTHER', 'name': 'questionnaire administration', 'armGroupLabels': ['Arm I']}, {'type': 'BEHAVIORAL', 'name': 'exercise intervention', 'armGroupLabels': ['Arm I']}, {'type': 'PROCEDURE', 'name': 'quality-of-life assessment', 'armGroupLabels': ['Arm I'], 'otherNames': ['quality of life assessment']}, {'type': 'OTHER', 'name': 'survey administration', 'armGroupLabels': ['Arm I']}, {'type': 'PROCEDURE', 'name': 'management of therapy complications', 'armGroupLabels': ['Arm I'], 'otherNames': ['complications of therapy, management of']}, {'type': 'PROCEDURE', 'name': 'psychosocial assessment and care', 'armGroupLabels': ['Arm I'], 'otherNames': ['psychosocial assessment', 'psychosocial assessment/care', 'psychosocial care', 'psychosocial care/assessment', 'psychosocial studies', 'psychosocial support']}] | PrimaryOutcomes: [{'measure': 'Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program', 'timeFrame': 'Approximately 24 months'}, {'measure': 'BMI', 'timeFrame': '6 months'}, {'measure': 'Muscular strength', 'timeFrame': '6 months'}, {'measure': 'Range of motion', 'timeFrame': '6 months'}, {'measure': 'Quality of life', 'timeFrame': '6 months'}, {'measure': 'Proportion of screened women who are eligible for the study and the proportion of eligible women who agree to participate', 'timeFrame': 'Approximately 24 months'}, {'measure': 'Proportion of women who complete the study and the average number of weeks of participation', 'timeFrame': 'Approximately 24 months'}] | SecondaryOutcomes: N/A |
Title: Examining a Fast Movement Approach to Pediatric Therapy Intervention in Children and Adolescents That Have Completed Medical Treatment for Acute Lymphoblastic Leukemia | Condition: Childhood Cancer | Keywords: physical therapy, functional mobility | Summary: | Description: We are performing a feasibility study to examine a movement based intervention that utilizes fast movements through jumping rope to improve balance, coordination, movement speed, and movement agility. The abilities to generate fast movements are required to perform functional activities and for playing sports. Participants will receive five in-person PT sessions and a home program for six weeks. The goal of this research is to determine the feasibility, acceptability, and promise of a PT program that emphasizes fast movements in ALL CCS. | ArmGroups: [{'label': 'One group that all receive the intervention of jumping rope.', 'type': 'EXPERIMENTAL', 'description': 'All participants will be in one group. Every participant receives the same intervention.', 'interventionNames': ['Behavioral: JUMP']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'JUMP', 'description': 'Warm-up, stretching, jumping rope, cool-down', 'armGroupLabels': ['One group that all receive the intervention of jumping rope.']}] | PrimaryOutcomes: [{'measure': 'Gross Motor Proficiency', 'description': 'Bruininks-Oseretsky Test of Motor Proficiency 2nd edition (BOT-2) (subtest 4, 5, 6, 8: bilateral coordination, balance, running speed and agility, and strength). The BOT-2 is a reliable and valid norm-referenced instrument designed for children and adolescents 4-21 years old.', 'timeFrame': '20 minutes'}] | SecondaryOutcomes: [{'measure': "Children's Assessment of Participation and Enjoyment (CAPE) questionnaire.", 'description': 'The CAPE are designed for use with children ages 6-21 years old.', 'timeFrame': '10 minutes'}, {'measure': 'electromyography (EMG)', 'description': 'The EMG onset will be defined by the time when the EMG burst is 3 standard deviations above the baseline muscle activity. The slope of the muscle activity, which is the linear regression line of best fit for the values between the onset of the EMG, and the peak of the EMG burst amplitude will be calculated and normalized by dividing the slope by the peak amplitude. The EMG burst slope reflects the recruitment and firing rate of motor units at the onset of the contraction, which is important for producing fast responses.', 'timeFrame': '5 minutes'}, {'measure': 'Preferences for Physical Activity for Children (PAC)', 'description': 'This is a survey to explore physical activity preferences of children.', 'timeFrame': '10 minutes'}, {'measure': 'Vertical Jump Height', 'description': 'Participants will perform five vertical jumps starting in the upright standing position with their feet on two adjacent force platforms. The instructions will be to "jump straight up as high as you can".', 'timeFrame': '5 minutes'}, {'measure': 'Peak vertical ground reaction', 'description': 'participant is asked to jump on the force platform. Takeoff is defined as the highest vertical ground reaction force value attained from the force time record for the takeoff phase of each jump, minus body mass', 'timeFrame': '5 minutes'}, {'measure': 'Motion Capture Analysis', 'description': 'The 3D motion analysis will be captured with a VICON T10 Camera with Nexus Software VICON markers will be placed on each shoe in the position of the great toe, ankle (lateral malleoli), lateral knee (proximal to the apex of the fibular head), greater trochanter of the hip, shoulder (greater tubercle of the humerus), lateral elbow (distal to lateral epicondyle), the wrist (styloid process), and head (wearing a headband).', 'timeFrame': '5 minutes'}] |
Title: Vaginal Dilatators and Moisturizers Use and Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy. | Condition: Pelvic Cancer, Cervical Cancer | Keywords: cervical and endometrial cancer, brachytherapy, patient education program, sexual quality of life, vaginal stenosis, patient-reported outcomes | Summary: | Description: Pelvic cancer accounts for 38,000 cancer cases in France; among them, 15,500 are gynecologic, i.e. endometrial, ovarian, cervical, vaginal and vulval. In 2017, 8,367 new endometrial cancer cases were reported in France1. Endometrial cancer mostly affects women who already underwent menopause; indeed, the median age at diagnosis is 68 years. Cervical cancer is less frequent, with 2,835 new cases reported in France in 2017, but affects younger women. The incidence peak is reported at 40 years, with a median age at death of around 50 years.
The standard of care for cervical cancer combines chemoradiotherapy with utero-vaginal brachytherapy, followed or not with surgery. For endometrial cancer, post-operative vaginal brachytherapy is recommended for intermediate-risk tumors or following radiotherapy for high-risk patients. However, in both cancer localizations, the combination of external radiation and brachytherapy induces numerous adverse effects affecting the patients' overall and sexual quality of life. Digestive, urinary and sexual disorders reported include abdominal pain, incontinence, cystitis, dyspareunia, vaginal irritation, pain during intercourse. A major adverse effect reported is reduction of vaginal elasticity together with vaginal shrinking (shorter and tighter vagina), up to vaginal stenosis. The EMBRACE study showed in 630 patients with locally-advanced cervical cancer a grade ≥ 2 vaginal stenosis rate of 21% at 2 years. A study reported that among sexually active women, 54% were not satisfied or little satisfied with their sexual activity; about 50% women also reported vaginal dryness and more than 40% pain during penetration. The EMBRACE study reported in locally-advanced cervical cancer patients the persistence of treatment-related symptoms, diarrhea, menopausal symptoms, peripheral neuropathy and sexual functioning problems two years after diagnosis. Vaginal dryness, hot flashes and pain at penetration were reported up to 5 to 10 years after diagnosis in cancer survivors as compared with controls in a case-control study. In endometrial cancer patients, a long-term analysis of the PORTEC-2 study reported vaginal dryness, short or narrow vagina and pain during intercourse at 7 years after treatment.
Studies in psycho-oncology or nursing care have assessed the impact of these disorders and are bringing up some solutions, among which use of vaginal dilators to prevent vaginal stenosis and improve sexual quality of life. International guidelines were issued on the use of vaginal dilators by these patients. Both guidelines and studies assessing patient education interventions to increase the patients' use of the vaginal dilators concluded on the possible benefit of educational programs stenosis prevention. Some programs well integrated in the patients' care pathway have been published. Early interventions starting as soon as the disease announcement consult with the radiation oncologist are still needed to improve vaginal stenosis prevention and the patients' sexual quality of life.
In this context, the investigator have initiated, for the first time in France, the "Gyn and Co LR" patient education program, approved by the Regional Health Agency. This program, fully integrated in the patients' care pathway, aimed to optimize an early care of sexual disorders and prevent vaginal stenosis in patients treated with brachytherapy for cervical or endometrial cancer. | ArmGroups: N/A | Interventions:[{'type': 'OTHER', 'name': 'Questionnaires', 'description': "The self-questionnaire of 104 questions collected personal and socio-demographics data, global and sexual quality of life characteristics (European Organisation for Research and Treatment of Cancer \\[EORTC\\] quality of life questionnaires: QLQ-C30 and gynecologic and cervical cancer specific-questionnaire QLQ-CX24), vaginal dilatators and moisturizers use, and barriers and facilitators of their use. Clinical data were extracted from the patients' medical files. Vaginal stenosis was evaluated at 6 weeks after the end of brachytherapy and after 1-year follow-up by in-town gynecologists or in our Institute, and censored in case of complete vaginal obliteration"}] | PrimaryOutcomes: [{'measure': 'Socio-demographics characteristics of patients who followed the "Gyn and Co LR" education program', 'description': 'Quality of life questionnaire: EORTC-QLQ-C30, EORTC QLQ-CX24', 'timeFrame': '1 day'}, {'measure': 'Clinical characteristics of patients who followed the "Gyn and Co LR"', 'description': 'Quality of life questionnaire: EORTC-QLQ-C30, EORTC QLQ-CX24', 'timeFrame': '1 day'}] | SecondaryOutcomes: [{'measure': 'Rate of vaginal dilatators and moisturizers use', 'description': 'Auto questionnaire', 'timeFrame': '1 day'}, {'measure': 'Vaginal stenosis prevalence', 'description': 'Clinical data from the patient medical file', 'timeFrame': '1 day'}, {'measure': 'Urinary or sexual adverse effects', 'description': 'Clinical data from the patient medical file', 'timeFrame': '1 day'}, {'measure': "Patients' overall and sexual quality of life", 'description': 'Sexual quality of life questionnaire:EORTC QLQ-CX24', 'timeFrame': '1 day'}] |
Title: Salvage Cryoablation of the Prostate (SCAP) vs High Intensity Focal Ultrasounds (HIFU) for Recurrent Prostate Cancer After Radiation Therapy | Condition: Cryotherapy, High Intensity Focused Ultrasounds, Recurrent Prostate Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'SCAP', 'description': 'Patients with recurrent prostate cancer undergoing SCAP', 'interventionNames': ['Procedure: Local treatment of the prostate (SCAP or HIFU)']}, {'label': 'HIFU', 'description': 'Patients with recurrent prostate cancer undergoing HIFU', 'interventionNames': ['Procedure: Local treatment of the prostate (SCAP or HIFU)']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Local treatment of the prostate (SCAP or HIFU)', 'description': 'Once the local involvement of the recurrent prostate cancer is confirmed, patient will undergo local treatment of the prostate (SCAP or HIFU)', 'armGroupLabels': ['HIFU', 'SCAP']}] | PrimaryOutcomes: [{'measure': 'DFS-histology', 'description': 'Disease free survival (confirmed by follow-up biopsy)', 'timeFrame': '1 year'}, {'measure': 'DFS-image', 'description': 'Disease free survival (confirmed by follow-up PET-CT )', 'timeFrame': '1 year'}, {'measure': 'ADT-FS', 'description': 'Androgen deprivation therapy free survival.', 'timeFrame': '5 years'}] | SecondaryOutcomes: [{'measure': 'BCR free survival', 'description': 'Time free of biochemical recurrence (PSA)', 'timeFrame': '5 years'}, {'measure': 'MFS-PET', 'description': 'Metastasis free survival. rate of patients without any metastasis detected on PET-CT.', 'timeFrame': '5 years f-u'}, {'measure': 'Complications rate', 'description': 'Rate of early and long-term complications', 'timeFrame': '1 year'}, {'measure': 'Continence', 'description': 'Change in continence scores (ICIQ-SF q)', 'timeFrame': '1 year'}, {'measure': 'Sexual function', 'description': 'Changes in sexual function (IIEF questionanaire)', 'timeFrame': '1 year'}, {'measure': 'Low urinary tract function', 'description': 'Changes in IPSS questionnaire', 'timeFrame': '1 year'}] |
Title: Dose-Defining Study of a NAT2 Phenotype-Based Dosing Regimen of Intravenous Amonafide L-Malate Administered Weekly in Men With Androgen-Independent Prostate Cancer (AIPC) | Condition: Prostate Cancer | Keywords: | Summary: | Description: This is an open-label, Phase I/II, multicenter study of Amonafide in subjects with androgen-independent metastatic prostate cancer.
Amonafide is metabolized by N-acetylation to an active metabolite, N-acetyl-Amonafide. Inter-subject differences in N-acetylation can explain the variability in Amonafide-induced myelosuppression. This dose-defining protocol has been designed to assess safety and efficacy of Amonafide in men with androgen-independent prostate cancer, assigned to individualized doses based on acetylator phenotype information.
The total duration of this study will be approximately 12 - 16 months: approximately 6 - 10 months for enrollment, and approximately 6 months for subject screening, treatment, and follow up per protocol. Subjects will be treated until PSA progression, disease progression, or unacceptable toxicity.
Subjects may continue participation in the study after Cycle 5 at the investigator's discretion if PSA progression, disease progression, or unacceptable toxicities are not reported. If a subject fulfills a criterion of PSA progression or disease progression, yet in the opinion of the investigator, the subject appears to be deriving clinical benefit from the study medication, a request may be made to the Xanthus medical monitor to allow that subject to continue study participation on a compassionate basis.
A follow-up evaluation for all subjects will be done 30 - 35 days after receiving the last dose of Amonafide. Subjects will be contacted every 3 months for survival after completion of the active phase of the study, until death.
PSA response will be reported for all subjects receiving Amonafide treatment. PSA levels will be measured at Screening and once per treatment cycle thereafter (at Day 1 of each cycle). A PSA responder will be defined as a subject experiencing a 50% decrease in PSA level, confirmed four or more weeks later, with no demonstration of clinical or radiographic evidence of disease progression prior to the second PSA measurement. Duration PSA response and time to PSA progression will also be reported.
In addition to PSA endpoints, traditional response criteria such as overall tumor response rate (complete + partial tumor response), duration of tumor response, and time to tumor progression will be captured for all subjects with measurable lesions. All complete and partial responses must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are met.
Subsequently, in order to evaluate safety, all subjects will be assessed for signs of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3 dated June 10, 2003.
All serious adverse events (SAEs) and grade ¾ toxicities will be reviewed by the Sponsor's medical monitor. Appropriate action may be taken to terminate or put the study on hold if warranted by unanticipated toxicity. | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'Amonafide L-malate (drug)'}] | PrimaryOutcomes: [{'measure': 'The Primary Objectives of this study are:'}, {'measure': 'To define and validate the safety of a NAT2 pheontypically driven dosing regimen;'}, {'measure': 'To define the pharmacokinetic and pharmacodynamic profile of Amonafide with a weekly intravenous administration schedule.'}] | SecondaryOutcomes: [{'measure': 'The Secondary Objectives of this study are:'}, {'measure': 'To determine the efficacy of weekly intravenous Amonafide for all enrolled subjects as defined by PSA response (decrease in PSA of 50% or greater), duration of PSA response, and time to PSA progression;'}, {'measure': 'To determine the overall tumor response (e.g., complete response or partial response), duration of tumor response, and time to tumor progression among subjects with measurable lesions using standard (RECIST) criteria.'}] |
Title: Transplantation of HLA Haploidentical Marrow Cells After Ex Vivo Exposure to Recipient Alloantigen in Presence of CTLA4-Ig - A Phase II Study of Tolerance Induction in Donor T Cells by Blockade of the CD80/CD86:CD28 Costimulatory Signal | Condition: Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes | Keywords: recurrent childhood acute lymphoblastic leukemia, refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, recurrent childhood lymphoblastic lymphoma, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, meningeal chronic myelogenous leukemia, adult acute myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, childhood myelodysplastic syndromes | Summary: | Description: OBJECTIVES: I. Determine the incidence and severity of acute graft versus host disease after transplantation of HLA haploidentical bone marrow preincubated with alloantigen and CTLA4-Ig ex vivo in patients with hematologic malignancies. II. Determine the engraftment rate with this treatment regimen in these patients. III. Determine the safety of this treatment regimen in these patients. IV. Determine the incidence of infection and relapse after this treatment regimen in these patients. V. Determine whether host specific tolerance develops in these patients after receiving this treatment regimen.
OUTLINE: This is a multicenter study. Patients undergo leukapheresis to collect white blood cells which are incubated with donor bone marrow cells in the presence of CTLA4-Ig for 36 hours. Patients undergo total body irradiation on days -7, -6, -5, and -4 and receive cyclophosphamide IV on days -3 and -2. Patients with acute lymphocytic leukemia, prior lymphoid blast crisis chronic myelogenous leukemia, high grade non-Hodgkin's leukemia (NHL), intermediate grade NHL with prior marrow or extramedullary disease, or prior CNS leukemia receive 2 doses of methotrexate intrathecally prior to bone marrow transplantation, and 4-6 doses following. Patients receive bone marrow transplantation on day 0; methotrexate IV on days 1, 3, 6, and 11; and cyclosporine IV on days -1 to 50. Patients are followed weekly for 1 month, monthly for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 1-2 years. | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'cyclophosphamide'}, {'type': 'DRUG', 'name': 'cyclosporine'}, {'type': 'DRUG', 'name': 'methotrexate'}, {'type': 'PROCEDURE', 'name': 'allogeneic bone marrow transplantation'}, {'type': 'PROCEDURE', 'name': 'in vitro-treated bone marrow transplantation'}, {'type': 'RADIATION', 'name': 'radiation therapy'}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer, a Phase II Randomized Multi-center Trial With and Without APX005M, an Anti-CD40 Agonist | Condition: Locally Advanced Rectal Adenocarcinoma | Keywords: | Summary: | Description: A phase II randomized trial 3:2 with short course radiotherapy followed by mFOLFOX chemotherapy prior to trans abdominal resection with or without an antiCD40 agonist antibody (APX005M). There will be continuous safety assessment for at least 6 patients. Planned accrual of 58 patients. An interim analysis after 30 patients have completed treatment and there will be early stopping criteria for futility or efficacy. Short course radiotherapy will consist of 5Gy x 5 to the pelvis and patients on APX005M arm will receive one infusion during radiotherapy course, have a two week break, then start FOLFOX with APX005M in conjunction with five out of six cycles of chemotherapy. Patients will be restaged and then undergo definitive surgery. | ArmGroups: [{'label': 'APX005M on day 3 of RT & day 3 of cycles 1-5 of mFOLFOX', 'type': 'EXPERIMENTAL', 'description': 'On Day 3 of Cycles 1-5 of each mFOLFOX treatment, participants will receive another dose of APX005M. The sequence of administration of APX005M in combination with mFOLFOX. In Cycle 6, participants will receive only mFOLFOX. After completing the last planned dose of mFOLFOX, participants will be considered off-protocol directed therapy and undergo planned TME, per institutional standards, and proceed to the follow-up portion of this study.', 'interventionNames': ['Drug: APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days']}, {'label': 'Radiation Therapy 5Gy x 5 days, mFOLFOX', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants randomized to Arm 2 will receive short-course RT and mFOLFOX regimen, except that participants will not receive any of the study drug. After completing the last planned dose of mFOLFOX, participants will be considered off-protocol directed therapy and undergo planned TME, per institutional standards, and proceed to the follow-up portion of this study.', 'interventionNames': ['Drug: mFOLFOX and Radiation Therapy 5Gy x 5 days']}] | Interventions:[{'type': 'DRUG', 'name': 'APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days', 'description': '1. APX005M 0.3mg/kg intravenously on day 3 of radiation and on day 3 of cycles 1-5 of mFOLFOX\n2. Short course radiation therapy 5 Gy x 5 days\n3. Oxaliplatin 85mg/m2 intravenous day 1 of each cycle\n4. Leucovorin 400mg/m2 IV Day 1 of each cycle\n5. 5-FU 2400 mg/m2 continuous infusion over 46 hours of each cycle', 'armGroupLabels': ['APX005M on day 3 of RT & day 3 of cycles 1-5 of mFOLFOX']}, {'type': 'DRUG', 'name': 'mFOLFOX and Radiation Therapy 5Gy x 5 days', 'description': '1. Short course radiation therapy 5 Gy x 5 days\n2. Oxaliplatin 85mg/m2 intravenous day 1 of each cycle\n3. Leucovorin 400mg/m2 IV Day 1 of each cycle\n4. 5-FU 2400 mg/m2 continuous infusion over 46 hours of each cycle', 'armGroupLabels': ['Radiation Therapy 5Gy x 5 days, mFOLFOX']}] | PrimaryOutcomes: [{'measure': 'Pathological Complete Response Rate', 'description': 'The primary objective of this study is to determine the pathologic complete response (pCR) rate of the combined treatment modality.', 'timeFrame': 'At time of surgery'}] | SecondaryOutcomes: [{'measure': 'Overall Survival', 'description': 'To evaluate overall survival (OS), defined as the time between date of randomization and the date of death due to any cause.', 'timeFrame': '3 years'}, {'measure': 'Toxicity analysis', 'description': 'To evaluate toxicity analysis comparing the experimental from the standard arm measured according to CTCAE v5.0.', 'timeFrame': '3 years'}, {'measure': 'Disease free survival', 'description': 'To evaluate the disease free survival (DFS) and patterns of failure at three years. DFS is defined as the time between the date of definitive surgery and the first date of documented disease progression or death.', 'timeFrame': '3 years'}] |
Title: Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer | Condition: Stress | Keywords: group therapy | Summary: | Description: N/A | ArmGroups: [{'label': 'Cognitive behavioral stress management group', 'type': 'EXPERIMENTAL', 'description': 'Participants received the cognitive behavioral stress management intervention for 10 weeks.', 'interventionNames': ['Behavioral: Cognitive behavioral stress management']}, {'label': 'Health promotion group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants received the health promotion group for one day.', 'interventionNames': ['Behavioral: Psychoeducational Control']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Cognitive behavioral stress management', 'description': 'Participants will receive in-person weekly stress management group sessions (3-8 participants) for two hours per week for ten weeks total. Each session will consist of a half hour of relaxation training and one and a half hours of stress management skill training, including coping effectiveness training, anger management, assertiveness training, and stress awareness.', 'armGroupLabels': ['Cognitive behavioral stress management group']}, {'type': 'BEHAVIORAL', 'name': 'Psychoeducational Control', 'description': 'Participants will receive one four-hour seminar in-person groups (3-8 participants) of educational information related to prostate cancer and abbreviated psychological information provided in cognitive behavioral stress management.', 'armGroupLabels': ['Health promotion group']}] | PrimaryOutcomes: [{'measure': 'Change in Perceived Stress Management Abilities as measured by the Measure of Current Status Questionnaire', 'description': 'The Measure of Current Status questionnaire is a 23-item questionnaire each scored on a range of 0-4. The total score ranges from 0-92 with the higher score corresponding to greater perceived abilities.', 'timeFrame': 'Baseline, up to 18 months'}, {'measure': 'Change in post-traumatic event perceptions as measured by the Benefit Finding Scale questionnaire', 'description': 'The Benefit Finding Scale questionnaire is a 17-item measure capturing perception of a traumatic event (e.g., cancer diagnosis for participants) with each item scored on a scale of 1 to 5. The total score ranges from 17-85 with the higher score corresponding to greater perceived benefit.', 'timeFrame': 'Baseline, up to 18 months'}, {'measure': 'Change in optimism as measured by the Life Orientation Test - Revised questionnaire', 'description': "The Life Orientation Test - Revised questionnaire measures participant's optimism. The total score ranges from 0-24 with the higher score corresponding to greater levels of optimism.", 'timeFrame': 'Baseline, up to 18 months'}, {'measure': 'Change in immune cell count', 'description': 'Immune cell count (including T-cell (Cluster of Differentiation (CD) 3+) and T-helper cells (CD 3+ CD 4+) will be evaluated from blood samples. Both values will be evaluated in count per cubic millimeter.', 'timeFrame': 'Baseline, up to 18 months'}, {'measure': 'Change in immune cell percentage', 'description': 'Immune cell percentage (including T-cell (Cluster of Differentiation (CD) 3+) and T-helper cells (CD 3+ CD 4+) will be evaluated from blood samples. Both values evaluated in count per cubic millimeter over total cell count per cubic millimeter.', 'timeFrame': 'Baseline, up to 18 months'}, {'measure': 'Change in natural killer cell percentage', 'description': 'Natural killer cell (CD56+CD3-) percentage is evaluated from blood samples. Values are evaluated in count per cubic millimeter over total cell count per cubic millimeter.', 'timeFrame': 'Baseline, up to 18 months'}, {'measure': 'Change in natural killer cell count', 'description': 'Natural killer cell (CD56+CD3-) count is evaluated from blood samples. Values are evaluated in count per cubic millimeter.', 'timeFrame': 'Baseline, up to 18 months'}, {'measure': 'Change in natural killer cell cytotoxicity as captured by activity percentage', 'description': 'Natural killer cell (CD56+CD3-) cytotoxicity is evaluated from blood samples. Cells are stimulated through exposure to a reactive cell line and the percentage of cells active are counted and divided by total cells present per cubic millimeter.', 'timeFrame': 'Baseline, up to 18 months'}, {'measure': 'Change in ratio of natural killer cell cytotoxicity as captured by Lytic Index', 'description': 'Natural killer cell (CD56+CD3-) cytotoxicity is evaluated from blood samples. Cells are stimulated through exposure to a reactive cell line and quantified as the ratio of responsive to unresponsive cells required to kill 10% of the target cell line.', 'timeFrame': 'Baseline, up to 18 months'}, {'measure': 'Change in count of natural killer cell cytotoxicity as captured by Kinetic Lytic Index', 'description': 'Natural killer cell (CD56+CD3-) cytotoxicity is evaluated from blood samples. Cells are stimulated through exposure to a reactive cell line and incubated for four hours total. Kinetic lytic index is quantified as the count of targeted cells killed during incubation. An average count of these cells will be calculated.', 'timeFrame': 'Baseline, up to 18 months'}] | SecondaryOutcomes: N/A |
Title: The Effect of Sujok Therapy on Pain, Fatigue, Insomnia, Nausea and Vomiting Experienced by Patients With Gastrointestinal System Cancer | Condition: Cancer | Keywords: Pain, Insomnia, Fatigue, Nausea and Vomiting, gastrointestinal system cancer., sujok therapy | Summary: | Description: The aim of this study is to determine the effect of Sujok treatment on Pain, Fatigue, Insomnia, Nausea and Vomiting experienced by patients with gastrointestinal system cancer. Intervention and control groups will be determined by randomization. The scales to be used in the measurement will be applied to the individuals included in the study. Then, sujok therapy will be applied to the intervention group. After 6 sessions in weeks in total, measurement tools will be applied and evaluated again. | ArmGroups: [{'label': 'Experimental group', 'type': 'EXPERIMENTAL', 'description': 'In the hand area, firstly, the points will be determined by means of the diagnostic stick and massage will be applied with buckwheat seeds. This massage will be 3 sessions a week, and a total of 6 sessions in 2 weeks.', 'interventionNames': ['Behavioral: sujok therapy']}, {'label': 'control group', 'type': 'NO_INTERVENTION', 'description': 'A questionnaire will be applied to the patients by the researcher. Questionnaires will be made as pre-test and post-test.'}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'sujok therapy', 'description': 'sujok therapy', 'armGroupLabels': ['Experimental group']}] | PrimaryOutcomes: [{'measure': "Sujok Therapy's Positive Change in Pain Experienced by Gastrointestinal System Cancer Patients", 'description': 'To assess the pain, the MCgill Pain Scale will be applied before starting the sujok application and after the sujok applied for 2 weeks.', 'timeFrame': '2 weeks'}, {'measure': "Sujok Therapy's positive change in Fatigue Experienced by Patients with Gastrointestinal System Cancer", 'description': 'To assess the fatigue, the cancer fatigue scale will be applied before starting the sujok application and after the sujok applied for 2 weeks.', 'timeFrame': '2 weeks'}, {'measure': "Sujok Therapy's positive cahange in insomnia Experienced by Patients with Gastrointestinal System Cancer", 'description': 'In order to evaluate insomnia,the insomnia severity index will be applied before starting the sujok application and after the sujok applied for 2 weeks', 'timeFrame': '2 weeks'}, {'measure': "Sujok Therapy's positive cahange in nausea and vomiting Experienced by Patients with Gastrointestinal System Cancer", 'description': 'To evaluate nausea and vomiting, the Rhodes nausea vomiting scale will be applied before starting the sujok application and after the sujok applied for 2 weeks', 'timeFrame': '2 weeks'}] | SecondaryOutcomes: N/A |
Title: LIFECHAMPS: A Collective Intelligence Platform to Support Cancer Champions Small-Scale Pilot | Condition: Breast Cancer, Prostate Cancer | Keywords: Cancer, mHealth App, Ambient Sensors, Wearables, Smartwatch, Smart scale, Analytics Engine | Summary: | Description: "The LifeChamps project (https://lifechamps.eu/) is creating a digital platform to support clinical teams to provide more integrated follow-up care to older patients with cancer. The digital platform will integrate data coming directly from the patient (patient-reported outcomes and sensor data from wearable devices), from the home environment (home sensors, weight scales), and from the clinical environment (data routinely collected via the Electronic Health Record). The digital platform will use big data analytics (machine learning) to process all data as part of predictive clinical algorithms for frailty and quality of life for older patients with cancer. Development of each clinical algorithm requires that the prototype model (or analytics engine) is trained using abundant real-world data to help consolidate the predictive ability and validity of the algorithms before the algorithms are deployed in a larger scale feasibility trial.
A prospective, time series design will be employed, whereby the LifeChamps platform will be deployed for a total of 3 months.
Older patients with a cancer diagnosis will be the target population for this study. Consecutive sampling will be used, whereby all older patients with cancer who meet the eligibility criteria will be approached and invited in the study. Each study participant will be involved in the study for 3 months in total. A 3-month recruitment period will be allowed, bringing the total study duration to 6 months (from first patient being enrolled until last patient finishing data collection).
AUTH: Patients aged 65 years and above, diagnosed with early-stage breast or prostate cancer will be identified at the Department of Medical Oncology at G. Genimatas General Hospital, "Alma Zois" a non-profit association of women who had experienced breast cancer based in Thessaloniki, Greece and collaborating private clinics. The patients will be presented with the opportunity to participate in the study and screened based on the inclusion and exclusion criteria. Potential participants will be provided with the information sheet and the consent form, informed that should they decline to participate this will not change their current treatment and provided the opportunity to ask any questions they may have.
Region Stockholm : Melanoma survivors aged 65 years and above, who have completed primary treatment within the last 12 months prior to the study, will be identified by our clinical partners within primary and secondary care in Region Stockholm. Online advertisements for the study will also be disseminated and participants may be recruited through LifeChamps partners (e.g. Karolinska Institute) or the Swedish melanoma patient association (Melanomföreningen) which will direct them to an online recruitment form within Region Stockholm. The researchers will then make a follow-up call to confirm interest in study participation. During the contact, the melanoma survivor will be asked to provide their written consent or decline participation and ask for a second contact before his/her final decision. All declining melanoma survivors will be thanked for their time and reassured that their decision will have no impact on their current or future treatment and care. All consenting participants will be reassured that they can withdraw at any time that they desire from the study.
After written informed consent has been provided, the mini-COG will be used to evaluate study participants' cognitive function and impairment at baseline. The mini-COG consists of a 3-word recall and a clock-drawing test, and can be completed within 5 minutes. A score of less than 3/5 indicates the need to refer the patient for full cognitive assessment.
The researcher will also arrange for study participants to receive study equipment, i.e. home sensors, wearable activity sensors, smart weight scale, and mobile app. The researcher will arrange a suitable time for a home visit to install the home sensors and test functionality. The researcher will demonstrate use of study equipment to the participant, and reiterate that support with use of the technology will be available.
Data collection will involve a variety of sources, including the patient (patient-reported outcomes and sensor data from wearable devices), the home environment (home sensors, weight scales), and the clinical site (data routinely collected via the Electronic Health Record).
The following technology will be used:
* Mobile devices:
* Activity tracker wristband (FitBit charge 4). It will be used to passively monitor and collect data on heart rate, heart rate variability, steps, activity tracking, sleep monitoring, breathing rate, skin temperature and SpO2.
* Mobile app (SALUMEDIA). It will be used to enable collection of patient-reported outcome measures (PROMs) and to forward this information along with the data gathered by the activity tracker and the smart scale to the Raspberry Pi Kit at home.
* At home sensors / devices:
* LOCS Home sensors: They will be used to monitor participants' daily activities e.g., to track ambulation and functioning. Study participants will be provided with 4 motion sensors, 1 door contact sensor, 2 corridor sensors, and a tag device.
* Smart Scale (Withings Body+): It will be used to measure weekly body weight, body composition and body mass index.
* Raspberry Pi (RPI) kit: As an edge gateway, RPI is hosting LOCS gateway, Movesense Gateway and data ingestion service. RPI will enable data collection and edge analytics and transfer of data to the LIFECHAMPS platform.
* Smart plug: It will be used to collect data about use home appliances and thereby data about active daily living.
Selected study participant clinical and demographic data from the local EHRs will be collected and loaded onto the LifeChamps analytics engine. The data will be loaded by technical partners via the LifeChamps dashboard for processing and analysis. Data regarding recruitment rate (patients consenting / patients approached), participant retention in the study, reasons for study discontinuation (if offered), participant adherence with technology, issues with technology and need for troubleshooting will be recorded. These data will (a) be recorded by local researchers using bespoke 'recording logs' in the form of an Excel spreadsheet, and (b) remotely monitored and logged by technical partners involved in the distribution / management of the technology to be used in the trial as described above." | ArmGroups: [{'label': 'LifeChamps Platform', 'type': 'EXPERIMENTAL', 'description': 'Participants will be asked to use the LifeChamps platform and will be provided with the study equipment.', 'interventionNames': ['Other: LifeChamps Platform']}] | Interventions:[{'type': 'OTHER', 'name': 'LifeChamps Platform', 'description': "Participants will be provided with the study equipment, i.e., a mobile app, smartwatch, smart scale, location home sensor, a smart plug, and a micro-computer, with which they will need to interact with the devices for three months. Specifically, participants should wear the activity tracker wristband (Fitbit Charge 4) as much as possible. Additionally, participants should use the smart scale to weigh themselves and the mobile app to fill in selected PROMs monthly, while the ambient home sensors (location home senor (LOCS) and smart plug) will be passively collecting information about their everyday living during these three months. Lastly, participants' clinical and demographic data from the local EHRs will be collected.", 'armGroupLabels': ['LifeChamps Platform']}] | PrimaryOutcomes: [{'measure': 'Analytical models', 'description': 'The collected data will be used to train and test the analytical models. For example, the initial data from sensors will be refined, further, with statistical, spectral and supervised learning analyses to identify and extract possible patterns (e.g., activities of daily living) inside their signals. Sensor, EHR and PROM data will be all analysed together through exploratory algorithms (e.g., pairwise Markov random fields, Bayesian networks) to identify possible interactions and dependencies among their trajectories, mapping the frailty and QOL domains of elderly prostate and breast cancer patients across all the data collection process.', 'timeFrame': '6 months'}] | SecondaryOutcomes: [{'measure': 'Anxiety and Depression', 'description': 'Core symptoms/signs of depression and anxiety as measured by PHQ-4 via 0-3 Likert scales, with 3 being the worst.', 'timeFrame': '3 months'}, {'measure': 'Symptoms', 'description': "Initial assessment symptoms palliative care patients' symptoms as measured by ESAS-r via 0-10 Likert scales, with 10 being the worst, and a blank scale for patient-specific symptoms.", 'timeFrame': '3 months'}, {'measure': 'Medication Adherence', 'description': 'Level of adherence to medication as measured by MARS via a Medical adherence Report Scale (MARS) via "yes" or "no" questions attributed with a 0 or 1 point (according to the content of the question), which are then used to calculate a score of adherence.', 'timeFrame': '3 months'}, {'measure': 'Frailty', 'description': "Function-based risk assessment of health deterioration in older adults as measured by VES-13 via a No Difficulty-Unable to do Likert scale and Yes/No/Don't do questions. All these are attributed to specific points used to calculate the final score. Scoring ranges between 0 and 10, 10 being the worse outcome.", 'timeFrame': '3 months'}, {'measure': 'Quality of Life assessment', 'description': 'Quality of life assessment as measured by LASA via 0-10 Likert scales, with 10 being the best.', 'timeFrame': '3 months'}, {'measure': 'Illness perception', 'description': "Cognitive and emotional representations of illness as measured by Brief Illness Perception Questionnaire via eight 0-10 Likert scaled questions and one open ended. The questionnaire does not have a best or worst outcome, rather it attempts to ascertain the patient's perception of the illness.", 'timeFrame': '3 months'}, {'measure': 'Prostate cancer symptoms', 'description': 'Tracking symptoms of prostate cancer as measured by International Prostate Symptom Score (IPSS) via 0-5 Likert scales, with 5 signifying higher frequency of symptoms.', 'timeFrame': '3 months'}, {'measure': 'Erectile Dysfunction', 'description': 'Assessment of erectile/sexual function as measured by International Index Erectile Function-6 via 0-5 Likert scales, with 5, being the best outcome', 'timeFrame': '3 months'}, {'measure': 'Quality of Life due to Urinary symptoms', 'description': 'Part of International Prostate Symptom Score measured by a 0-6 Likert scale with 6 being the worst.', 'timeFrame': '3 months'}] |
Title: PD-1 Inhibitors (Camrelizumab) Combined With VEGF Inhibitors (Apatinib) for Locally Advanced dMMR/MSI-H Colorectal Cancer: an Open-label, Multi-center, Phase II Clinical Trial | Condition: Colorectal Cancer, Microsatellite Instability High | Keywords: | Summary: | Description: This is an open-label phase II study, with the aim of determining the efficacy of PD-1 inhibitors (Camrelizumab) plus VEGF inhibitor (Apatinib) as a neoadjuvant therapy for dMMR/MSI-H locally advanced colorectal cancer.
Patients will be evaluated for eligibility within 14 days prior to study initiation with CT (for colon cancer) and/or MRI (for rectal cancer).
Patients will be given four cycles of Camrelizumab (200mg iv every 3 weeks) plus Apatinib (250mg QD day1-14) before being evaluated for response. For patients with colon cancer, if a SD/PD is achieved and the tumor is deemed unresectable, they will be offered chemotherapy±radiotherapy, while if a CR or PR is achieved, they will be offered another four cycles of Camrelizumab + Apatinib. After completing 8 cycles of treatment, if a CR is achieved they will be offered the choice of Watch \& Wait. For patients with rectal cancer who have a SD/PD (after 4 cycles), chemoradiotherapy will be offered, while for those with a CR/PR, another four cycles of the treatment will be given. After completing 8 cycles of treatment, if a CR is achieved patients will be offered the choice of Watch \& Wait. | ArmGroups: [{'label': 'PD-1 inhibitors plus VEGF inhibitors', 'type': 'EXPERIMENTAL', 'description': 'Patients will be given 4 cycles of Camrelizumab (200mg iv every 3 weeks) plus Apatinib (250mg QD day1-14) before being evaluated for response.', 'interventionNames': ['Drug: PD-1 inhibitor plus VEGF inhibitors']}] | Interventions:[{'type': 'DRUG', 'name': 'PD-1 inhibitor plus VEGF inhibitors', 'description': 'Camrelizumab 200mg IV every 3 weeks; Apatinib 250mg QD day 1-14. Rescue chemotherapy: Oxaliplatin 130mg/m2 IV drip Q3W d1+Capecitabine 1000mg/m2 QD d1-d14 Rescue chemoradiotherapy: Long-course radiotherapy +Capecitabine 825mg/m2 QD d1-d14', 'armGroupLabels': ['PD-1 inhibitors plus VEGF inhibitors'], 'otherNames': ['Camrelizumab plus Apatinib']}] | PrimaryOutcomes: [{'measure': 'Clinical complete response or pathological complete response', 'description': 'Clinical complete response or immunotherapy-related pathological complete response (cCR or immunotherapy-related pCR)', 'timeFrame': 'up to 2 year'}] | SecondaryOutcomes: [{'measure': 'Objective Response Rate (ORR, PR+CR)', 'description': 'Partial response + complete response', 'timeFrame': 'up to 2 year'}, {'measure': '3-year relapse-free survival', 'timeFrame': 'up to 3 years'}, {'measure': '3-year overall survival', 'timeFrame': 'up to 3 years'}, {'measure': 'Surgical complications', 'timeFrame': 'within 1 month after surgery'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'up to 2 year'}] |
Title: Characterizing and Addressing Financial Toxicity in Adolescents and Young Adults with Cancer | Condition: Cancer in Adolescence | Keywords: Cancer, Adolescents, Young Adults, Financial Needs, Social Needs, Minority health, Caregivers | Summary: | Description: Financial toxicity is the harmful personal financial burden faced by patients due to healthcare needs. A prevalent adverse outcome of cancer therapy, financial toxicity is associated with poorer health outcomes and increased mortality in adults with cancer. Among cancer survivors, financial burden disproportionately impacts adolescents and young adults (AYA: 15 - 39 years). Lack of financial security, insurance gaps or under-insurance, and interruptions in education or careers caused by cancer therapy make AYA cancer survivors particularly vulnerable to financial burden. Financial toxicity of cancer care is an actionable factor impacting outcomes among vulnerable AYA populations. In order to improve outcomes and reduce the burden of care among these populations, targeted, appropriate measures and then, age-specific interventions are needed. The study includes the following aims: Aim 1 involves the adaptation of the COST measure and assessment of the psychometric properties of the measure for a racial/ethnically diverse group of AYAs. The study team will administer COST and additional AYA-specific financial toxicity candidate items to N=150 AYAs. The study will assess validity of original COST through confirmatory factor analysis; assess reliability through test/retest; conduct exploratory factor analysis on modified COST incorporating added items; and describe AYA-reported acceptability of AYA financial toxicity assessment.
In Aim 2, an adapted FN/FE intervention will be adapted for a racial/ethnically diverse group of AYAs. 6 focus groups (6 - 8 per group) will be conducted with a diverse AYAs and caregivers, and brief stakeholder discussions to understand unique AYA FE/FN needs and inform intervention refinement.
Aim 3 will include a pilot test of our novel FE/FN intervention to AYAs. A FE/FN intervention will be delivered to at least N=30 AYAs, and assess feasibility by evaluating program completion (6-months), participant-reported acceptability. Evidence of efficacy will be recorded by measuring improvement in average financial toxicity score between baseline and 6-month time points. | ArmGroups: [{'label': 'Patient Financial Education / Navigation', 'type': 'EXPERIMENTAL', 'description': 'Individuals who screen positive will all move forward to receive the intervention. This intervention includes partnering with community-based organizations to deliver financial education, connection to resources, and counseling tailored to individual patients and spouses for 6-months.', 'interventionNames': ['Behavioral: Patient Financial Education / Navigation']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Patient Financial Education / Navigation', 'description': 'The investigator anticipates that this will include a baseline financial assessment and educational content, likely using a virtual platform. Participants will be connected with a PAF case manager. There will be monthly follow-ups to the participant for 6-months to address any financial concerns through additional counseling/navigation.', 'armGroupLabels': ['Patient Financial Education / Navigation']}] | PrimaryOutcomes: [{'measure': 'Number of (OR percentage of) participants who completed the intervention', 'description': 'This is to assess the feasibility of intervention completion. Intervention completion is defined as participants who have demonstrated contact with community partners at any time before the end of 6 months.', 'timeFrame': 'Up to 6 months'}, {'measure': 'Percentage of eligible participants who consented to be in study', 'description': 'This is to measure interest and the need for help by community partners that can provide patient financial education and navigation.', 'timeFrame': 'Up to 6 months'}] | SecondaryOutcomes: [{'measure': 'Comprehensive Score of Financial Toxicity (COST measure)', 'description': 'The COST is a patient-reported outcome measure that describes the financial distress experienced by cancer patients. It is a 11-item questionnaire with a score range of 0-44. Lower COST values indicate higher toxicity. Higher scores indicate lower financial toxicity .', 'timeFrame': 'Baseline, 6 months'}] |
Title: Phase II Study of Oxaliplatin and CPT-11 as First Line Treatment for Extensive Stage Small Cell Lung Cancer | Condition: Small Cell Lung Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'Irinotecan (CPT-11)'}, {'type': 'DRUG', 'name': 'Oxaliplatin (Eloxatin)'}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates Plus The Immunological Adjuvant QS21 | Condition: Prostate Cancer | Keywords: stage III prostate cancer, recurrent prostate cancer | Summary: | Description: OBJECTIVES:
* Determine the safety of glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 in patients with prostate cancer.
* Determine the antibody response in patients treated with this vaccination therapy.
* Assess post-immunization changes in PSA levels and other objective parameters of disease (radionuclide bone scan) in patients treated with this vaccination therapy.
OUTLINE: Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 subcutaneously once weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity. Patients whose antibody titers against Globo-H or MUC-2 antigens fall below 1/40 and who have no disease progression may receive a seventh vaccination after week 50.
Patients are followed every 3 months for 1 year or until biochemical relapse or radiographic disease progression. | ArmGroups: [{'label': 'vaccine', 'type': 'EXPERIMENTAL', 'description': 'Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 subcutaneously once weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity. Patients whose antibody titers against Globo-H or MUC-2 antigens fall below 1/40 and who have no disease progression may receive a seventh vaccination after week 50.\n\nPatients are followed every 3 months for 1 year or until biochemical relapse or radiographic disease progression.', 'interventionNames': ['Biological: MUC-2-Globo H-KLH conjugate vaccine', 'Biological: QS21']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'MUC-2-Globo H-KLH conjugate vaccine', 'armGroupLabels': ['vaccine']}, {'type': 'BIOLOGICAL', 'name': 'QS21', 'armGroupLabels': ['vaccine']}] | PrimaryOutcomes: [{'measure': 'safety', 'timeFrame': '2 years'}] | SecondaryOutcomes: [{'measure': 'response', 'timeFrame': '2 years'}] |
Title: Safety and Efficacy of Disitamab Vedotin Combined With Sintilimab as First-line Treatment of Elderly Patients With HER2 Overexpression Gastric Cancer | Condition: Gastric Cancer | Keywords: | Summary: | Description: The primary objective of this study was to explore the safety and median PFS of Disitamab vedotin combined with Sintilimab as first-line treatment in elderly patients with HER2 overexpression Gastric Cancer.The secondary objective of this study was to evaluate the ORR, DCR, DOR and OS of Disitamab vedotin combined with Sintilimab as first-line treatment in elderly patients with HER2 overexpression Gastric Cancer.To provide a better treatment plan for elderly patients with Gastric Cancer. | ArmGroups: [{'label': 'Disitamab Vedotin Combined With Sintilimab', 'type': 'EXPERIMENTAL', 'description': 'Treatment regimen is Disitamab vedotin 2.5mg/kg and Sintilimab 200mg every 21 days, until disease progression or intolerable adverse reactions or death.', 'interventionNames': ['Drug: Disitamab Vedotin Combined With Sintilimab']}] | Interventions:[{'type': 'DRUG', 'name': 'Disitamab Vedotin Combined With Sintilimab', 'description': 'Disitamab Vedotin injection：2.5mg/kg，IV，Q3W Sintilimab injection：200mg，IV, Q3W', 'armGroupLabels': ['Disitamab Vedotin Combined With Sintilimab'], 'otherNames': ['Combined treatment group']}] | PrimaryOutcomes: [{'measure': 'PFS (Progression-Free-Survival)', 'description': 'The time from randomization to tumor progression or death.The efficacy of this study was determined according to Recist version 1.1 criteria.', 'timeFrame': '24 months'}] | SecondaryOutcomes: [{'measure': 'ORR（Objective Response Rate）', 'description': 'The rate of participants that achieve either a complete response (CR) or a partial response (PR).', 'timeFrame': '24 months'}, {'measure': 'DCR（Disease control rate）', 'description': 'The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.', 'timeFrame': '24 months'}, {'measure': 'DOR（Duration of response）', 'description': 'DoR was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the PFS censoring time.', 'timeFrame': '24 months'}, {'measure': 'OS (Overall survival time)', 'description': 'The time of death from all causes for all patients from the date of randomization.', 'timeFrame': '24 months'}, {'measure': 'The Adverse Events', 'description': 'AEs are any adverse medical events that occur in a subject or clinical subject and is not necessarily causally related to the treatment. Safety assessment in this study was conducted by the investigator in accordance with the definition of CTCAE 5.0.', 'timeFrame': '24 months'}] |
Title: Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1811 for Injection in Subjects With Advanced Non-small Cell Lung Cancer Who Have HER2 Expression , Amplification, or Mutation | Condition: Advanced Non-small Cell Lung Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'SHR-A1811', 'type': 'EXPERIMENTAL', 'description': 'SHR-A1811 was administered intravenously every 3 weeks (Q3W) until discontinuation treatment', 'interventionNames': ['Drug: SHR-A1811']}] | Interventions:[{'type': 'DRUG', 'name': 'SHR-A1811', 'description': 'Phase 1 Drug: SHR-A1811 There are four pre-defined dose regimens . Subjects will be enrolled with an initial dose Phase 2 Drug: SHR-A1811 Doses will be determined from Phase 1', 'armGroupLabels': ['SHR-A1811']}] | PrimaryOutcomes: [{'measure': 'Phase 1:Incidence of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811', 'description': 'Assess safety and tolerability of SHR-A1811 by way of adverse events (CTCAE v5.0)', 'timeFrame': 'From Day 1 to90 days after last dose ，appropriately to 3 years'}, {'measure': 'Phase 1:Severity of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811', 'description': 'Assess safety and tolerability of SHR-A1811 by way of adverse events (CTCAE v5.0)', 'timeFrame': 'From Day 1 to90 days after last dose ，appropriately to 3 years'}, {'measure': 'Phase1: Maximum tolerated dose (MTD)', 'description': 'Incidence rate and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A1811 treatment', 'timeFrame': '12 months'}, {'measure': 'Phase 1: Recommended Phase 2 dose (RP2D)', 'description': 'RP2D was determined based on the safety, tolerability, PK, immunogenicity data and efficacy information obtained', 'timeFrame': '12 months'}, {'measure': 'Phase2:ObjectiveResponse Rate (ORR)', 'description': 'As assessed by RECIST v1.1 , as assessed by independent review committee (IRC)', 'timeFrame': 'Subjects were evaluated on tumor imaging every 6 weeks after treatment initiation and every 12 weeks after 54 weeks, until imaging progression, initiation of new antitumor therapy, loss of follow-up, and death，appropriately to 3 years'}] | SecondaryOutcomes: [{'measure': 'Phase 1：PK parameter ：Tmax of SHRA1811', 'description': 'Time to maximal concentration (Tmax) of SHR-A1811', 'timeFrame': 'appropriately to 3 years'}, {'measure': 'Phase1:PK parameter: Cmax of SHR-A1811', 'description': 'Maximal concentration (Cmax) of SHR-A1811', 'timeFrame': 'appropriately to 3 years'}, {'measure': 'Phase1:PK parameter: AUC0-t of SHR-A1811', 'description': 'AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811', 'timeFrame': 'appropriately to 3 years'}, {'measure': 'Phase1:Immunogenicity of SHR-A1811', 'description': 'Including anti-drug antibody and/or neutralizing antibody', 'timeFrame': 'Immunogenicity sample collection time points include: within 30 min before administration of C1D1, C2D1, C3D1, C4D1, C6D1 and C8D1 starting from cycle 11 only in every 3 cycles ,appropriately to 3 years'}, {'measure': 'Phase2:Progression Free Survival (PFS)', 'description': 'As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator', 'timeFrame': 'appropriately to 3 years'}, {'measure': 'Phase2:ObjectiveResponse Rate (ORR)', 'description': 'As assessed by RECIST v1.1 , as assessed by investigator', 'timeFrame': 'appropriately to 3 years'}, {'measure': 'Phase2:Duration of response (DOR)', 'description': 'As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator', 'timeFrame': 'appropriately to 3 years'}, {'measure': 'Phase2:Disease control rate (DCR)', 'description': 'As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator', 'timeFrame': 'appropriately to 3 years'}, {'measure': 'Phase2:Overall survival (OS)', 'timeFrame': 'Approximately 5 years after last subject enrolled'}] |
Title: Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Adenocarcinoma of the Prostate | Condition: Metastatic Prostate Cancer | Keywords: adenocarcinoma of the prostate | Summary: | Description: Metastatic Pancreatic Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
* To determine the efficacy of Antineoplaston therapy in patients with Metastatic Pancreatic Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with Metastatic Pancreatic Cancer.
* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. | ArmGroups: [{'label': 'Antineoplaston therapy', 'type': 'EXPERIMENTAL', 'description': 'Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.', 'interventionNames': ['Drug: Antineoplaston therapy (Atengenal + Astugenal)']}] | Interventions:[{'type': 'DRUG', 'name': 'Antineoplaston therapy (Atengenal + Astugenal)', 'description': 'Patients with Metastatic Pancreatic Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).\n\nThe daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.', 'armGroupLabels': ['Antineoplaston therapy'], 'otherNames': ['A10 (Atengenal); AS2-1 (Astugenal)ANP']}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: Recurrent Predictive Power of Circulating Tumor Cells in Non Small Cell Lung Cancer Patients Who Receive Curative Resection | Condition: Lung Cancer Recurrent | Keywords: | Summary: | Description: Study subject:
Inclusion criteria 1. Patients with clinical stage 1 to 3a non-small lung cancer 2. Patients with a resectable suspicious pulmonary lesion which is difficult for pre-operation tissue prove or refused for pre-operation biopsy 3. Received curative intended tumor resection Exclusion criteria
1. Small cell lung cancer component which identified in pathology
2. Patients who presented as stage IIIb or IV
3. Not received curative intended surgery due to multi-comorbidities
4. Patients who presented in tumor seeding or positive resection in pathology confirmation
5. Patients who received neoadjuvant therapy
Data collection:
medical record review and blood sampling for circulating tumor cell purification
Timing of blood sampling:
a.Pre-operation, post-operation, post-operation day 1, post-operation day 3 b regular OPD surveillance (3 month-interval) for 3 years
Blood sampling: 20 ml blood that withdrawn from a peripheral vein
Circulating tumor cell purification: two-step procedure
1. cell isolation: centrifugation, isolated karyocyte \> 10 micrometer
2. negative selection: wash out RBC, WBC depletion
3. positive selection: purify circulating tumor cell (karyocyte which presented CD 45 negative, Epi-CAM positive, diameter greater 10 micrometer
Result analysis:
Combine the medical record to analyze the relationship between circulating tumor cells and disease relapse | ArmGroups: N/A | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Variation trend of circulating tumor cell counts', 'description': 'Relationship between variation trend of circulating tumor cells and disease relapse in patients with a suspicious pulmonary lesion after tumor resection', 'timeFrame': '1. Circulating tumor cell counts in pre-op, post-op, post-operation day 1 and post-operation day 3 ; 2.need complete 5-years surveillance (disease status confirmation)'}, {'measure': 'Validation of variation trend of circulating tumor cell counts', 'description': 'sequence patient recruitment for validation', 'timeFrame': '1. Circulating tumor cell counts in pre-op, post-op, post-operation day 1 and post-operation day 3 ; 2.model establish model (case 1 to 50) versus validation group ( case 51-120) 3. need complete 5-years surveillance (disease status confirmation)'}] | SecondaryOutcomes: N/A |
Title: A Phase 1 Study of ZW49 in Patients With Locally Advanced (Unresectable) or Metastatic HER2-Expressing Cancers | Condition: HER2-expressing Cancers | Keywords: HER2, Bispecific antibody, Biparatopic antibody, Immunotherapy, Gastric cancers, Esophageal cancers, Gastroesophageal junction (GEJ) cancers, Breast cancer, Ovarian cancer, Non-small cell lung cancer, Colorectal cancer, Cholangiocarcinoma | Summary: | Description: The study will use a 3+3 dose-escalation study design to evaluate the safety and tolerability of ZW49 and to determine the MTD or RD of ZW49 for further study. Selected expansion cohorts will be subsequently opened based upon Safety Monitoring Committee (SMC) recommendation and sponsor approval to further evaluate the safety and tolerability of ZW49 at the MTD or RD and to assess preliminary anti-tumor activity. | ArmGroups: [{'label': 'ZW49', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: ZW49']}] | Interventions:[{'type': 'DRUG', 'name': 'ZW49', 'description': '* Dose Escalation: ZW49 administered intravenously at dose levels determined by the SMC\n* Expansion: MTD or RD identified in the dose-escalation part of the study', 'armGroupLabels': ['ZW49']}] | PrimaryOutcomes: [{'measure': 'Incidence of dose-limiting toxicities (DLTs)', 'description': 'Number of participants who experienced a DLT. DLTs are events that occur following administration of any amount of ZW49 and are considered related to ZW49 per the investigator. DLTs will include only events considered related to ZW49.', 'timeFrame': 'Up to 4 weeks'}, {'measure': 'Incidence of adverse events', 'description': 'Number of participants who experienced an adverse event', 'timeFrame': 'Up to 7 months'}, {'measure': 'Incidence of lab abnormalities', 'description': "Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology and chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.", 'timeFrame': 'Up to 7 months'}, {'measure': 'Incidence of electrocardiogram (ECG) and left ventricular ejection fraction (LVEF) abnormalities', 'description': 'Number of participants who experienced an abnormal ECG or LVEF', 'timeFrame': 'Up to 7 months'}, {'measure': 'Incidence of dose reductions of ZW49', 'description': 'Number of doses reduced and number of participants who require a dose reduction', 'timeFrame': 'Up to 7 months'}] | SecondaryOutcomes: [{'measure': 'Serum concentrations of ZW49', 'description': 'End of infusion concentration, maximum serum concentration, and trough concentration of ZW49', 'timeFrame': 'Up to 7 months'}, {'measure': 'Incidence of anti-drug antibodies (ADAs)', 'description': 'Number of participants who develop ADAs', 'timeFrame': 'Up to 7 months'}, {'measure': 'Objective response rate (ORR)', 'description': 'Number of participants who achieved a best response of either complete or partial response during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1', 'timeFrame': 'Up to 6 months'}, {'measure': 'Disease control rate', 'description': 'Number of participants who achieved a best response of complete response, partial response, or stable disease during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1', 'timeFrame': 'Up to 6 months'}, {'measure': 'Duration of response', 'description': 'Median duration of response (in months) and range (minimum, maximum)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Progression-free survival', 'description': 'Median progression-free survival (in months) and range (minimum, maximum)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Overall survival', 'description': 'Median overall survival (in months) and range (minimum, maximum)', 'timeFrame': 'Up to 2 years'}] |
Title: The Florida Pancreas Collaborative Next-Generation Biobank: Reducing Health Disparities and Improving Survival for Pancreatic Cancer | Condition: Pancreatic Cancer, Cancer Cachexia | Keywords: pancreas, biobank, quantitative imaging, biomarkers, health disparities | Summary: | Description: Doctors, researchers, and patient advocates from numerous institutions throughout the state of Florida have formed a partnership known as the Florida Pancreas Collaborative. The goals of the Florida Pancreas Collaborative team are to find better ways to diagnose and treat pancreatic cancer and improve quality of life. Recent research suggests that pancreatic cancer affects people of various racial and ethnic groups differently, with some groups having more aggressive disease and a poorer prognosis than other groups.
In this research study, the investigators want to partner with individuals known or suspected to have pancreatic cancer to build a 'biobank' dedicated to minimizing disparities and personalizing care for individuals affected by pancreatic cancer. A biobank is a valuable resource that involves collection, processing, and storage of blood, other bodily fluids, and tissue (obtained during biopsy or surgery) to improve the investigator's understanding of health and disease. When combined with information and medical images obtained through routine care, the investigators will be able to investigate biological processes that may underlie differences and poor outcomes and target them with more effective therapeutic strategies tailored to the individual. | ArmGroups: [{'label': 'All Participants', 'description': 'Blood samples, tumor samples and data will be collected from all participants as applicable.', 'interventionNames': ['Other: Blood Sample Collection', 'Other: Tumor Sample collection', 'Other: Data Collection']}] | Interventions:[{'type': 'OTHER', 'name': 'Blood Sample Collection', 'description': 'Participants will be asked to donate blood at baseline (+/- 30 days of diagnosis date) and at the time of follow-up (approximately 6 months and approximately 12 months after baseline).', 'armGroupLabels': ['All Participants']}, {'type': 'OTHER', 'name': 'Tumor Sample collection', 'description': 'At the time of tissue biopsy and surgical resection (if applicable), pancreatic tumor tissue and tissue from site of metastasis will be collected.', 'armGroupLabels': ['All Participants']}, {'type': 'OTHER', 'name': 'Data Collection', 'description': 'Participants will be asked to complete a 3 page screening tool at the time of their in-person clinic visit, as well as questionnaires at baseline and at 6 and 12 months.', 'armGroupLabels': ['All Participants']}] | PrimaryOutcomes: [{'measure': 'Evidence of Precachexia', 'description': 'Cases will be evaluated for precachexia using the following guidelines: Anorexia with \\<5% weight loss over past 6 months along with metabolic changes that together indicate precachexia.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Evidence of Cachexia', 'description': 'Cases will be evaluated for cachexia using the following guidelines: Anorexia with \\>5% weight loss over past 6 months, along with metabolic changes that together indicate cachexia.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Evidence of Refractory Cachexia', 'description': 'Cases will be evaluated for refractory cachexia using the following guidelines: Anorexia \\>5% weight loss over 6 months along with specific metabolic changes that together indicate refractory cachexia.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Presence of Myopenia', 'description': 'Measures of skeletal muscle index (SMI) and psoas muscle index (PMI) for will be used for myopenia assessment.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Presence of Visceral Adiposity', 'description': 'Using CT scans at the axial L2-L3 level, the following radiologic measures of abdominal adiposity will be obtained: visceral fat area (VFA), subcutaneous fat area (SFA), total abdominal fat (TAF) area, and the VFA to SFA ratio (V/S). The VFA to SFA ratio (V/S) will be calculated with V/S \\> 0.4 defined as viscerally obese.', 'timeFrame': 'Up to 12 months'}] | SecondaryOutcomes: [{'measure': 'Overall Survival', 'description': 'Overall Survival will be defined as time from surgery to death from any cause', 'timeFrame': 'Up to 24 months'}, {'measure': 'Progression Free Survival', 'description': 'Progression Free Survival will be defined as time from surgery to pancreatic cancer recurrence or death.', 'timeFrame': 'Up to 24 months'}] |
Title: Initiation of Colon Cancer Screening in Veterans | Condition: Colorectal Neoplasms | Keywords: Colorectal Neoplasms, Mass Screening, Patient Compliance, Intervention Studies, Clinical Trial | Summary: | Description: Colorectal cancer (CRC) is the 2nd leading cause of cancer deaths in the US and risk increases with age. Colorectal cancer screening (CRCS) offers the possibility of both early detection and prevention. For those at average risk, CRCS beginning at age 50 is recommended. However, awareness and use of CRCS tests are low. We propose to conduct a randomized controlled trial to develop and test stepped interventions to increase initial uptake of CRCS in a nationally-representative, ethnically-diverse sample of male and female veterans. Our specific aims are to: (1) develop and pre-test stepped intervention components that are theory and evidence-informed; (2) implement and evaluate the process, efficacy, and cost-effectiveness of stepped interventions to increase an initial CRCS among male and female veterans aged 50-64 years; and (3) analyze the association between predictor variables and CRCS initiation and the mediating and moderating effects of the interventions, after each step. In Step 1, we will evaluate a theory-based minimal cue delivered by a letter, telephone call, or automated telephone call compared with a survey-only control group to determine whether the 3 different delivery channels are equally efficacious and cost-effective. Minimal cues are a cost-effective method that prompts to action those more willing to change and are easy to disseminate in real-world settings. Persons who do not complete CRCS in Step 1 will be randomized in Step 2 to more intensive interventions that address resistance. In Step 2 we will determine whether a theory-based, tailored telephone intervention, using principles of Motivation Interviewing, is effective when delivered as part of a sequential intervention process in which early adopters have been removed from the population. Step 2 also will determine whether an automated approach, telephone-linked communication (TLC), is as effective as a telephone counselor in promoting initiation of CRCS. Steps 1 and 2 together will address the important issue of the "dose" needed to encourage completion of CRCS. After each step, we will examine the mediating and moderating effects of the intervention to identify determinants of completion. For cancer screening intervention research to have the broadest public health impact, interventions must have the potential for dissemination. We designed our trial to move us toward the goal of disseminable interventions with evidence of external validity. | ArmGroups: [{'label': 'Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'A survey-only control arm will be compared to the experimental arm to determine whether the 3 different delivery channels are equally efficacious and cost-effective.', 'interventionNames': ['Behavioral: Control']}, {'label': 'Minimal Cue and TLC', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to the experimental arm will receive a minimal cue after completing the baseline survey. A follow up survey will be sent 9 months after completion of the minimal cue to assess whether the participant received CRCS. If the participant has not had CRCS they will receive a more intensive telephone linked communication intervention. A second follow up will be sent 9 months after the TLC is delivered to assess final screening status.', 'interventionNames': ['Behavioral: Stepped CRCS Interventions']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Stepped CRCS Interventions', 'description': 'In Step 1, we will evaluate a theory-based minimal cue delivered by a letter, telephone call, or automated telephone call. Persons who do not complete CRCS in Step 1 will be randomized to Step 2 using principles of Motivation Interviewing. Step 2 also will determine whether an automated approach, telephone-linked communication (TLC), is as effective as a telephone counselor in promoting initiation of CRCS. Steps 1 and 2 together will address the important issue of the "dose" needed to encourage completion of CRCS.', 'armGroupLabels': ['Minimal Cue and TLC'], 'otherNames': ['Start Screening Now']}, {'type': 'BEHAVIORAL', 'name': 'Control', 'description': 'A survey-only control arm will be compared to the experimental arm to determine whether the 3 different delivery channels are equally efficacious and cost-effective.', 'armGroupLabels': ['Control']}] | PrimaryOutcomes: [{'measure': 'Colorectal Cancer Screening', 'description': 'The primary outcome for the intervention trial is completion of an initial CRCS with 1 of the 5 currently recommended tests or test combinations. There will be one follow up measurement after each intervention step to assess whether uptake of CRCS was completed. The first measure is 9 months after the 1st intervention step. The second is 9 months after the 2nd intervention step.', 'timeFrame': '9 month follow up'}] | SecondaryOutcomes: N/A |
Title: Genetic Information to Inform Treatment and Screening (GIFTS) Study for Prostate Cancer | Condition: Prostate Carcinoma | Keywords: | Summary: | Description: OUTLINE:
Participants complete questionnaire over 20 minutes at baseline, then undergo collection of saliva sample for genetic testing. Participants identified to have an inherited mutation in a deoxyribonucleic acid (DNA) repair gene undergo genetic counseling. Participants whose genetic testing does not indicate an inherited mutation in a DNA repair gene receive a letter thanking them for their participation and emphasizing the importance of ongoing communication with their physician and family members about cancer risk.
Participants will be sent newsletters every year to encourage study engagement and update health questionnaires every two years. | ArmGroups: [{'label': 'Case Ascertainment', 'description': 'Men with prostate cancer', 'interventionNames': ['Behavioral: Questionnaire', 'Procedure: Biospecimen Collection', 'Diagnostic Test: Genetic Testing', 'Other: Genetic Counseling', 'Other: Laboratory Biomarker Analysis']}, {'label': 'Family Recruitment', 'description': 'Male relatives of men with prostate cancer', 'interventionNames': ['Behavioral: Questionnaire', 'Procedure: Biospecimen Collection', 'Diagnostic Test: Genetic Testing', 'Other: Genetic Counseling', 'Other: Laboratory Biomarker Analysis']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Questionnaire', 'description': 'Complete questionnaire', 'armGroupLabels': ['Case Ascertainment', 'Family Recruitment'], 'otherNames': ['Questionnaires']}, {'type': 'PROCEDURE', 'name': 'Biospecimen Collection', 'description': 'Provide saliva samples', 'armGroupLabels': ['Case Ascertainment', 'Family Recruitment'], 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection']}, {'type': 'DIAGNOSTIC_TEST', 'name': 'Genetic Testing', 'description': 'Undergo genetic testing', 'armGroupLabels': ['Case Ascertainment', 'Family Recruitment'], 'otherNames': ['Genetic Analysis', 'Genetic Examination', 'Genetic Test']}, {'type': 'OTHER', 'name': 'Genetic Counseling', 'description': 'Undergo counseling', 'armGroupLabels': ['Case Ascertainment', 'Family Recruitment']}, {'type': 'OTHER', 'name': 'Laboratory Biomarker Analysis', 'description': 'Correlative Studies', 'armGroupLabels': ['Case Ascertainment', 'Family Recruitment']}] | PrimaryOutcomes: [{'measure': 'Identification of a population-based cohort of men with prostate cancer (PC) and germline deoxyribonucleic acid (DNA) repair gene (gDRG) mutations', 'description': 'Identification to be determined through the Washington State Cancer Registry and by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in prostate cancer.', 'timeFrame': 'From the start of study through death (up to 20 years)'}, {'measure': 'Clinical, pathologic, and molecular predictors of gDRG mutation carriers for men with PC', 'description': 'Predictors to be identified by analyzing information provided by participants on their health history and potentially further testing or chart review on participants who consent to future contact.', 'timeFrame': 'From the start of study through death (up to 20 years)'}, {'measure': 'Utility and feasibility of cascade genetic testing through use of family history of men with PC identified to have gDRG mutations', 'description': "To be determined by collection of information about participants' family history and subsequent analysis of cascade genetic testing outcomes.", 'timeFrame': 'From the start of study through death (up to 20 years)'}, {'measure': 'Identification of a cohort of men with gDRG mutations without PC', 'description': 'Identification to be determined through family history of men with PC identified through the Washington State Cancer Registry and by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in prostate cancer.', 'timeFrame': 'From the start of study through death (up to 20 years)'}] | SecondaryOutcomes: N/A |
Title: A Phase 1, Open-Label, Dose Escalation Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of PF-04554878 In Patients With Advanced Non-Hematologic Malignancies | Condition: Cancer | Keywords: Focal Adhesion Kinase; Advanced Non-Hematologic Malignancies | Summary: | Description: N/A | ArmGroups: [{'label': '1', 'type': 'EXPERIMENTAL', 'description': 'Dose escalation study with Expansion Cohorts at RP2D and Schedule', 'interventionNames': ['Drug: PF-04554878']}] | Interventions:[{'type': 'DRUG', 'name': 'PF-04554878', 'description': 'Oral pills at increasing dose twice daily, 21 day cycle, continuous treatment schedule until progression of disease, unacceptable toxicity, or patient request. Some patients will undergo serial biopsy and/or FDG-PET imaging', 'armGroupLabels': ['1']}] | PrimaryOutcomes: [{'measure': 'Recommended Phase 2 Dose', 'timeFrame': '18 months'}, {'measure': 'Overall safety profile of PF-04554878, including Dose-Limiting Toxicity (DLT)', 'timeFrame': '18 months'}] | SecondaryOutcomes: [{'measure': 'Tumor metabolic response', 'timeFrame': '18 months'}, {'measure': 'PF-04554878 pharmacokinetic (PK) parameters and Midazolam PK parameters', 'timeFrame': '18 months'}, {'measure': 'FAK-related biomarkers in tumor biopsies and blood', 'timeFrame': '18 months'}, {'measure': 'Molecular profiling (genomics data) based on the optional studies with whole blood and/or tumor samples', 'timeFrame': '18 months'}] |
Title: The Use of Angiotensin Receptor Blockers and the Risk of Cancer | Condition: Neoplasm | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Patients prescribed antihypertensives', 'interventionNames': ['Drug: ARB', 'Drug: ACEI', 'Drug: Beta-blockers', 'Drug: Diuretics', 'Drug: Telmisartan']}] | Interventions:[{'type': 'DRUG', 'name': 'ARB', 'description': 'other than telmisartan', 'armGroupLabels': ['Patients prescribed antihypertensives']}, {'type': 'DRUG', 'name': 'ACEI', 'armGroupLabels': ['Patients prescribed antihypertensives']}, {'type': 'DRUG', 'name': 'Beta-blockers', 'armGroupLabels': ['Patients prescribed antihypertensives']}, {'type': 'DRUG', 'name': 'Diuretics', 'armGroupLabels': ['Patients prescribed antihypertensives']}, {'type': 'DRUG', 'name': 'Telmisartan', 'armGroupLabels': ['Patients prescribed antihypertensives']}] | PrimaryOutcomes: [{'measure': 'Number of patients with occurrences of lung, colorectal, breast and prostate cancers related to use of ARBs', 'timeFrame': '16 years'}, {'measure': 'Determination of dose-response in terms of ARB duration of use and cumulative dose and the risk of lung, colorectal, breast and prostate cancers combined', 'timeFrame': '16 years'}, {'measure': 'Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of ARBs, relative to beta-blockers and diuretics', 'timeFrame': '16 years'}, {'measure': 'Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan, relative to beta-blockers and diuretics', 'timeFrame': '16 years'}, {'measure': 'Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan relative to other ARBs', 'timeFrame': '16 years'}] | SecondaryOutcomes: [{'measure': 'Number of patients with occurrences of lung cancer related to use of ARBs alone', 'timeFrame': '16 years'}, {'measure': 'Number of patients with occurrences of colorectal cancer related to use of ARBs alone', 'timeFrame': '16 years'}, {'measure': 'Number of patients with occurrences of breast cancer related to use of ARBs alone', 'timeFrame': '16 years'}, {'measure': 'Number of patients with occurrences of prostate cancer related to use of ARBs alone', 'timeFrame': '16 years'}, {'measure': 'Number of patients with occurrences of lung cancer related to use of ARBs with ACEI', 'timeFrame': '16 years'}, {'measure': 'Number of patients with occurrences of colorectal cancer related to use of ARBs with ACEI', 'timeFrame': '16 years'}, {'measure': 'Number of patients with occurrences of breast cancer related to use of ARBs with ACEI', 'timeFrame': '16 years'}, {'measure': 'Number of patients with occurrences of prostate cancer related to use of ARBs with ACEI', 'timeFrame': '16 years'}, {'measure': 'Ratio of occurrence of lung cancer related to use of telmisartan relative to other ARBs', 'timeFrame': '16 years'}, {'measure': 'Ratio of occurrence of colorectal cancer related to use of telmisartan relative to other ARBs', 'timeFrame': '16 years'}, {'measure': 'Ratio of occurrence of breast cancer related to use of telmisartan relative to other ARBs', 'timeFrame': '16 years'}, {'measure': 'Ratio of occurrence of prostate cancer related to use of telmisartan relative to other ARBs', 'timeFrame': '16 years'}] |
Title: Phase II Trial of Aerobic Training in Metastatic Breast Cancer | Condition: Metastatic Breast Cancer | Keywords: Stretching, Nonlinear Aerobic Training, 14-170 | Summary: | Description: N/A | ArmGroups: [{'label': 'Progressive Stretching Group', 'type': 'OTHER', 'interventionNames': ['Behavioral: Progressive Stretching Group', 'Other: Blood draw']}, {'label': 'Nonlinear Aerobic Training', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Nonlinear Aerobic Training', 'Other: Blood draw', 'Other: Cardiopulmonary Exercise Testing (CPET)']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Progressive Stretching Group', 'description': 'Participants assigned to the progressive stretching group will be provided with a progressive stretching program that matches the aerobic training interventions in terms of program length (16 weeks), social interaction (all sessions will be supervised), and session duration (20-45 minutes/session, ± 10 minutes).', 'armGroupLabels': ['Progressive Stretching Group']}, {'type': 'BEHAVIORAL', 'name': 'Nonlinear Aerobic Training', 'description': 'Participants assigned to the nonlinear aerobic training arm will perform no more than 150 minutes per week of structured supervised aerobic training as part of clinical trial participation. Exercise performed outside the structured sessions (i.e., contamination) will be assessed via self-report of exercise behavior using the Godin-Leisure Time Exercise Questionnaire (GLTEQ). For ethical reasons, we will not instruct participants not to exercise outside the structured sessions, but we we will encourage participants to maintain their level of exercise behavior prior to study initiation.', 'armGroupLabels': ['Nonlinear Aerobic Training']}, {'type': 'OTHER', 'name': 'Blood draw', 'description': 'At Weeks 4, and 8, all participants will have a complete blood count (CBC) test performed.', 'armGroupLabels': ['Nonlinear Aerobic Training', 'Progressive Stretching Group']}, {'type': 'OTHER', 'name': 'Cardiopulmonary Exercise Testing (CPET)', 'description': 'At the end of Week 6, participants repeat the CPET in the nonlinear aerobic training group.', 'armGroupLabels': ['Nonlinear Aerobic Training']}] | PrimaryOutcomes: [{'measure': 'safety of aerobic training', 'description': 'Safety will be evaluated by the type and prevalence of adverse events during study-related assessments as well as aerobic training and progressive stretching sessions. The NCI Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE) will be used to grade toxicities during the trial.', 'timeFrame': '2 years'}] | SecondaryOutcomes: [{'measure': 'feasibility of aerobic training', 'description': 'feasibility will be evaluated by examining several different end points including rates of study eligibility and accrual, etc; however, sample size calculations are based on an integration of aerobic training attendance rate (in the aerobic training group) as well as global trial attrition rates. Together, these end points will be used to determine overall study feasibility.', 'timeFrame': '2 years'}] |
Title: A Phase II Study to Evaluated the Long-term of Safety and Efficacy of Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors | Condition: Breast Cancer, Prostate Cancer, Non Small Cell Lung Cancer | Keywords: spinal metastases, Stereotactic body radiation therapy(SBRT), breast cancer, prostate cancer, non small cell lung cancer | Summary: | Description: Recently,Stereotactic Body Radiation Therapy(SBRT) become an alternative regimen for spinal metastases due to it's high dose cover the metastatic lesion and low dose in the adjacent spinal cord which result in more efficacy and less toxicity. However,the longterm of efficacy and safety of this regimen is unclear because of shortly median survival among unselective spinal metastases.To our knowledge,the median survival of some favorite metastatic diseases will be more than two years if they received appropriate system therapy.these include hormones dependent brest cancer/prostate cancer,and EGFR mutation non-small cell lung cancer(NSCLC) ect.The purpose of the study is to evaluate the longterm outcome of this therapeutic regimen in selective patients who will be survival more than 2 years. | ArmGroups: [{'label': 'Phase II open lable Study', 'type': 'EXPERIMENTAL', 'description': 'Eligible patients will receive Stereotactic body radiation therapy (SBRT) for spinal metastatic lesion in 24Gy/3f(cervical vertebra) or 30Gy/3f (thoracic vertebra/lumbar vertebra) every other day and receive relevant system treatment at same time.', 'interventionNames': ['Radiation: Stereotactic Body Radiation Therapy']}] | Interventions:[{'type': 'RADIATION', 'name': 'Stereotactic Body Radiation Therapy', 'description': 'Eligible patients will receive Stereotactic body radiation therapy (SBRT) for spinal metastatic lesion in 24Gy/3f(cervical vertebra) or 30Gy/3f (thoracic vertebra/lumbar vertebra) every other day and receive relevant system treatment at same time', 'armGroupLabels': ['Phase II open lable Study']}] | PrimaryOutcomes: [{'measure': 'The rate of relieve pain', 'description': 'According to the Numerical Rating Pain Scale (NRPS)', 'timeFrame': 'One week after radiation to 2 years late'}] | SecondaryOutcomes: [{'measure': 'The degree of relieve pain', 'description': 'According to the Numerical Rating Pain Scale (NRPS)', 'timeFrame': 'One week after radiation to 2 years late'}, {'measure': 'The duration relieve pain', 'description': 'According to the Numerical Rating Pain Scale (NRPS)', 'timeFrame': 'One week after radiation to 2 years late'}, {'measure': 'The incidence of toxicity', 'description': 'Common Terminology Criteria for Adverse Events v3.0 (CTCAE)', 'timeFrame': 'One week after radiation to 2 years late'}] |
Title: Magnetic Resonance Fingerprinting for Preoperative Evaluation of Lymphovascular Space Invasion in Early Stage Cervical Cancer | Condition: Cervical Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: N/A | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Association between T1-, T2- and ADC-maps and LVSI status', 'timeFrame': '3 months'}] | SecondaryOutcomes: [{'measure': 'Correlation between T1-, T2- and ADC-maps and DFS and OS', 'timeFrame': '3 years'}, {'measure': 'Correlation between Radiomics-based analysis and LVSI status and DFS and OS', 'timeFrame': '3 years'}] |
Title: Drivers of Hypoxia-induced Angiogenesis in Tumor Development | Condition: Von Hippel-Lindau Disease | Keywords: | Summary: | Description: Background Cancer cell development requires a series of acquired capabilities to grow and spread: 1) self-sufficiency in growth signals, 2) insensitivity to growth inhibition signals, 3) evasion of apoptosis (programmed cell death), 4) limitless replicative potential, 5) sustained angiogenesis and 6) tissue invasion and metastasis (Hanahan and Weinberg, 2000). The acquisition of these capabilities is driven by mutations in key oncogenes and tumors suppressor genes, although the exact mechanisms are not yet fully understood. Especially angiogenesis is crucial to a cell's survival as it's continued multiplication depends on the oxygen and nutrients supplied in the vasculature(Hanahan and Weinberg, 2000). Angiogenesis can be initiated by lack of oxygen (hypoxia), and the cell's oxygen sensing pathway mediates a response. Under normal conditions and in the presence of oxygen, the VHL protein, pVHL mediates the binding of a ubiquitin ligase complex to a group of transcription factors called Hypoxia inducible Factors (HIFs) and directs the HIF-α subunits to proteosomal degradation. Thus in normal cells with enough oxygen, HIF-α -induced transcription of target genes is inhibited. During hypoxia, the HIF-α is not hydroxylated and is therefore not recognized by the VHL protein. The HIFs translocate to the nucleus and induce transcription of numerous genes, many encoding angiogenic factors that stimulate new vessel growth(Maher et al., 2011;Nordstrom-O'Brien et al., 2010). Cancer growth requires vast amounts of oxygen and most tumor cells are in a constant state of hypoxia.
If there is no functional pVHL in a cell it reacts as if it needs oxygen, as HIFs will stimulate angiogenesis irrespective of oxygen levels. Therefore patients with germline mutations in the VHL gene can serve as a model of hypoxia-induced angiogenesis. Patients with germline VHL mutations have von Hippel-Lindaus disease (vHL) and are prone to tumor development due to this mechanism, mainly renal cell carcinoma and central nervous system (CNS) hemangioblastomas(Maher et al., 2011). Even though hemangioblastomas are histologically benign tumors, they can have serious consequences. The natural development of hemangioblastomas is characterized by unpredictable periods of growth and stagnation. Often they develop associated cysts that affect adjacent nervous tissue and cause massive symptoms, as even small volume changes in the brain can cause severe neurological damage or even death(Ammerman et al., 2006;Glasker et al., 2010;Wanebo et al., 2003).
The mechanisms behind vHL-associated tumorgenesis are complex and not yet fully understood. A key event is loss of a functional VHL protein product as a result of inactivation of both alleles of the VHL gene in accordance with Knudson's two hit hypothesis(Vortmeyer et al., 2013). However, it is also clear that though inactivation of both copies of a person's VHL gene is necessary, it does not seem to be sufficient for hemangioblastoma development(Vortmeyer et al., 2013;Vortmeyer et al., 2006;Vortmeyer et al., 2004). Biallelic VHL inactivation may be present in the form of multiple tumor precursors throughout predisposed tissues, and most never develop into actual symptom-causing tumors(Vortmeyer et al., 2013;Vortmeyer et al., 2006;Vortmeyer et al., 2004).
The key question to a better understanding of how to slow or stop tumor development is identification of which specific additional factors initiate or promote tumor development and growth. Tumor development may be initiated in a single cell that evades normal control of cell division, but as the cell divides and multiplies, the daughter cells go through a sequence of multiple genetic events in many different genes that accumulate and provide the tumor with growth advantages(Hanahan and Weinberg, 2011). Such a sequence from benign adenoma to malignant carcinoma has previously been mapped for colorectal cancer development and has been of immense importance to our current understanding of cancer development(Fearon and Vogelstein, 1990). In the case of hemangioblastomas, further knowledge about any common genetic events in other genes than the VHL gene that occur in the early stages of hemangioblastoma progression will help determine which specific genes may be driving, i.e. promoting growth and/or cyst development.
One group recently identified loss of HNF1B on chromosome 17q to be a potential molecular driver of hemangioblastoma tumorigenesis using analysis of copy number variation in tumor DNA(Sun M et al., 2014). Other groups have found evidence that loss of ZAC1 on chromosome 6q plays a major role in both vHL-associated and sporadic CNS hemangioblastoma tumorigenesis(Lemeta et al., 2007;Zhou et al., 2010). However, more systematic approaches investigating hemangioblastomas' genetic alterations in a broader perspective could markedly increase our knowledge of the sequence of genetic events leading from early stage tumor precursors to fully grown tumors. This knowledge is of vast importance, both in relation to our general understanding of tumorigenesis, but also in relation to detection of early necessary genetics events that occur in all hemangioblastomas at early stages of tumor development and may be driving the process. Such necessary events in the tumor precursor cells may be used as biomarkers in tissue biopsies or tumor cells that make it into the blood stream to determine which patients are most at risk of aggressive tumor growth. Finally, changes in specific genes that are known to be key steps in turning a tumor precursors into clinical significant tumors would be obvious candidates to target in the development of anti-tumor drugs.
Recently, next generation sequencing (NGS) techniques have been successfully used to determine genetic profiles and sequence of specific genetic events in relation to individual tumor progression in multiple other tumor types, including both sporadic and vHL-associated renal cell carcinoma (RCC)(Fisher et al., 2014;Gossage et al., 2015;Gundem et al., 2015;Kroigard et al., 2015). NGS makes it possible to examine somatic variations in a tumor's entire genome (i.e. variations that have developed specifically in the tumor's DNA and not in the patient's germline DNA)(Nik-Zainal, 2014).
The study investigators hypothesis that different CNS hemangioblastomas share genetic alterations in specific genes that promote or initiate tumor development from VHL-deficient cells, i.e. genetic drivers of tumor development. The investigators further hypothesize that some of these genetic alterations represent steps in the sequence of hemangioblastoma progression. By comparing genetic alterations in tumors at different stages of development, with different growth patterns, and with and without associated cyst development, the investigatorshope to elucidate the possible development-related genetic alterations that occur in this sequence. Based on how often genetic variants are shared by the separate tumors, it can be estimated which genes are likely involved at different stages in hemangioblastoma development. In this pilot project, the investigators plan to analyze separate tumors originating from the same patient as well as tumors originating from different patients to evaluate intra- and interpatient differences.
Findings of candidate genetic drivers in this project will subsequently be confirmed in a larger series of both vHL-associated as well as sporadic CNS hemangioblastomas, that will be collected in an ongoing process. Also, the investigators plan to compare the findings to recent findings of candidate genetic drivers in renal cell carcinomas in an ongoing project performed by some of our collaborators.
Material The investigators have identified Danish vHL patients through multiple national health registers, and asked patients over the age of 18 years to participate. Consenting participants were interviewed about their medical histories and the information verified through medical records.
The participants' VHL germline mutations are identified using DNA extracted from peripheral blood samples, and for this pilot project only those with an identifiable pathogenic VHL germline mutation found in DNA from peripheral lymphocytes using direct sequencing of exons and exon-intron boundaries and MLPA, will be included.
In the study tissue samples from all obtainable CNS hemangioblastomas that have been surgically removed as part of a participant's treatment will be collected, either as paraffin-embedded tissue, as fresh frozen tissue, or as fresh tissue conserved in RNAlater.
For the proposed project at least two attainable CNS hemangioblastomas from each participant will be selected NGS analysis. The investigators expect to be able to include DNA from at least 19 tumor samples, including DNA extracted from both paraffin-embedded tumor tissue, fresh frozen and tissue suspended in RNAlater.
Methods DNA from each participant is isolated from tumor tissue and from normal tissue (i.e. peripheral blood) using standard protocols. The paraffin-embedded tissue may contain both tumor tissue as well as normal surrounding tissue. To ensure that the DNA from the tissue represents the tumor-DNA, the investigators will first evaluate HE-stained sections and ensure that \> 85% of the tissue section contains tumor.
Exome enrichment of both tumor and normal tissue DNA will be performed using a Niblegen 64Mb panel including all known genes as well as miRNA and lincRNA genes. The enriched DNA will be sequenced using the Illumina Hiseq1500 platform with paired end sequencing of 2X100 bases and a mean coverage rate of 75-100 x. The results from each tumor DNA sample will be compared to DNA the patient's normal tissue to distinguish germline variations from tumor-specific genetic alterations and thereby obtain the profile of somatic genetic alterations belonging to the tumor DNA.
Somatic mutations will be identified using somatic variant caller software like VarScan, Mutect, EBCall, or Virmid. Identified somatic variants located to the tumor's exome will be assessed, and somatic copy number events will be identified through copy number profiling of the NGS data using ngCGH, Contra and Nexus software. Identified somatic point mutations will be validated using targeted deep sequencing. The investigators will select chromosomal candidate regions based on recurrent variants across tumors.
Each tumor's clinical characteristics prior to surgical removal will be assessed through evaluation of serial radiological data (MRIs of the CNS) from each participant's year-long annual surveillance and additional diagnostic examinations:
1. Tumor size: Assessed by tumor volume (width x length x height) x 0.5 (mm3)
2. Tumor development time: Assessed by time interval from the tumor was first visible on MRI to time of surgery
3. Tumor growth rate: Assessed by radiological progression, i.e. change in tumor volume/time interval between two MRIs (months)
4. Tumor growth phase: Assessed by which growth phase was the tumor in prior to surgery (stagnant vs. growth phase defined by change in tumor volume in the time intervals between the latest three MRIs)
5. Associated cyst development and cyst size prior to surgery: Assessed by cyst volume at last MRI prior to surgery.
This clinical information will be compared to the tumor's genetic profile to assess any clinical associations to possible molecular drivers. | ArmGroups: [{'label': '1', 'description': 'Individuals currently living, over the age of 18 years and known carriers of a pathogenic variant in the VHL gene.', 'interventionNames': ['Genetic: Whole exome sequencing']}] | Interventions:[{'type': 'GENETIC', 'name': 'Whole exome sequencing', 'description': 'DNA from CNS hemangioblastomas and normal tissue (blood) will be analysed using whole exome sequencing.', 'armGroupLabels': ['1']}] | PrimaryOutcomes: [{'measure': 'Somatic variants', 'description': 'somatic genetic variants', 'timeFrame': 'July 2019-December 2019'}] | SecondaryOutcomes: N/A |
Title: A Randomized Phase II Trial Combining Vaccine Therapy With PROSTVAC /TRICOM and Enzalutamide vs. Enzalutamide Alone in Men With Metastatic Castration Resistant Prostate Cancer | Condition: Prostate Cancer | Keywords: Immunotherapy, Gene Transfer, Androgen Receptor Antagonist, PSA, Immune Response | Summary: | Description: Background:
* Enzalutamide is a well-tolerated, modern androgen receptor antagonist (ARA) with more enhanced anti-tumor activity compared to previous ARAs. Phase III trial has demonstrated a 4.8 month improvement in survival and a 37% risk reduction in death in metastatic castration resistant prostate cancer (mCRPC) patients who have had previous docetaxel.
* PROSTVAC is a therapeutic cancer vaccine which is designed to induce an anti-tumor immune response. In a randomized controlled Phase 2 trial, PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) therapy was associated with a prolongation of survival by 8.5 months in men with metastatic castrate-resistant prostate cancer. An international Phase 3 trial is on-going.
* Preclinical data has demonstrated that hormonal therapies such as ARAs can enhance the immune response through multiple mechanisms. Specifically, our group has shown that enzalutamide can increase thymic production of na(SqrRoot) ve T-cells, which could be activated by a cancer vaccine. Together, these data provide an important rationale to combine enzalutamide with PSA-TRICOM in mCRPC.
* Data from the clinical trials with these therapies suggest that they are very well tolerated and without overlapping toxicity.
Objective:
-Determine if prostate-specific antigen (PSA)-TRICOM combined with enzalutamide will increase time to progression (as defined by Prostate Cancer Clinical Trials Working Group 2 criteria, incorporated in section 5.2) in chemotherapy-naive metastatic castration resistant prostate cancer patients compared to enzalutamide alone.
Design:
* The study will randomize chemotherapy-naive, mCRPC patients to either enzalutamide alone or enzalutamide with PSA-TRICOM. Enzalutamide will be given at the standard dose of 160 mg daily.
* PSA-TRICOM will be administered identical to the Phase III dosing with vaccine given week 1 (vaccinia-PSA-TRICOM, 2x10(8) units subcutaneously) and then week 3, 5 and then monthly fowlpox-vaccine (1x10(9) units subcutaneously).
* After completing 6 months of vaccine, fowlpox-vaccine (1x10(9) units subcutaneously will be administered every 3 months. Patients will be treated until radiographic progression on scans using Prostate Cancer Working Group Criteria.
Eligibility:
* mCRPC patients with rising PSA or progressive disease despite castration levels of testosterone.
* Chemotherapy-na(SqrRoot) ve with minimal or no symptoms related to prostate cancer.
* Patients with history of autoimmune disease, brain/leptomeningeal metastasis, a second malignancy within 3 years of enrollment, or a severe co-morbid condition will be excluded.
* Patients who have received abiraterone will be excluded
* Patients will be stratified based on previous immunotherapy used as cancer treatment. | ArmGroups: [{'label': 'Arm 1 - Enzalutamide alone', 'type': 'EXPERIMENTAL', 'description': 'Enzalutamide alone. Enzalutamide will be given at the standard dose of 160 mg daily.', 'interventionNames': ['Biological: Enzalutamide']}, {'label': 'Arm 2 - Enzalutamide with Prostate-Specific Antigen (PSA)-TRICOM', 'type': 'EXPERIMENTAL', 'description': 'Enzalutamide with PSA-TRICOM. Enzalutamide will be given at the standard dose of 160 mg daily with vaccine given week 1 (vaccinia-PSA-TRICOM, 2x10(8) infectious units subcutaneously) and then week 3, 5 and then monthly fowlpox-vaccine (1x10(9) infectious units subcutaneously).', 'interventionNames': ['Biological: PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM', 'Biological: PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM', 'Biological: Enzalutamide']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM', 'description': 'A recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules.', 'armGroupLabels': ['Arm 2 - Enzalutamide with Prostate-Specific Antigen (PSA)-TRICOM']}, {'type': 'BIOLOGICAL', 'name': 'PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM', 'description': 'A recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules.', 'armGroupLabels': ['Arm 2 - Enzalutamide with Prostate-Specific Antigen (PSA)-TRICOM']}, {'type': 'BIOLOGICAL', 'name': 'Enzalutamide', 'description': 'An androgen receptor inhibitor.', 'armGroupLabels': ['Arm 1 - Enzalutamide alone', 'Arm 2 - Enzalutamide with Prostate-Specific Antigen (PSA)-TRICOM'], 'otherNames': ['Xtandi']}] | PrimaryOutcomes: [{'measure': 'Time to Progression (TTP)', 'description': 'Time to progression is defined as the duration of time from start of treatment to time of disease progression. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions can also be considered progression if they meet the size criteria for target lesions.', 'timeFrame': 'Median follow-up of 55.4 months'}] | SecondaryOutcomes: [{'measure': 'Overall Survival', 'description': 'Overall survival is defined as the date of on-study to the date of death from any cause or last follow up.', 'timeFrame': 'Median potential follow-up of 68.5 months'}, {'measure': 'Time to Prostate-specific Antigen (PSA) Progression', 'description': 'PSA progression is defined by a sequence of rising values separated by \\>1 week (2 separate increasing values over a minimum of 2ng/ml or 25% higher (Prostate Cancer Clinical Trials Working Group (PCWG2) PSA eligibility criteria).', 'timeFrame': 'Median follow-up of 55.4 months'}] |
Title: Comparison of Real-World Effectiveness of Pegylated Liposomal Doxorubicin Versus Paclitaxel in Platinum- Sensitive Recurrent Ovarian Cancer | Condition: Ovarian Carcinoma | Keywords: | Summary: | Description: Worldwide, ovarian cancer is the sixth most common cancer and the seventh most common cause of cancer deaths in women. At the time of presentation, approximately 70% of women have advanced disease. Despite standard treatment of initial debulking surgery followed by chemotherapy in advanced ovarian cancer, most patients relapse after achieving a complete clinical response. Disease that responds to first-line therapy but relapses after 6 months after completion of initial platinum-based therapy is considered platinum sensitive (PS). Chemotherapy re-treatment is an important aspect in the overall management of patients with PS relapsed or recurrent ovarian cancer (ROC). Platinum is a backbone of treatment, and carboplatin and paclitaxel (CP) have emerged as standard in the first-line setting and been rechallenged in patients with platinum-sensitive ROC. A pooled analysis of three phase III trials from the AGO-OVAR and International Collaborative Ovarian Neoplasm collaborators demonstrated significant improvements in progression-free survival (PFS; hazard ratio \[HR\], 0.76; 95% confidence interval \[CI\], 0.66 to 0.89; P = .0004) and overall survival (OS; HR, 0.82; 95% CI, 0.69 to 0.97; P = .02) in patients with PS ROC treated with platinum-paclitaxel versus conventional platinum based therapies, mainly carboplatin monotherapy.
However, rechallenge with CP has been limited by the risk of cumulative peripheral neuropathy. In addition, grade 2 alopecia (complete hair loss), another ill-tolerated adverse effect for patients facing the distress of relapse, occurs in more than 80% of patients. In order to improve the patient's tolerance on the treatment in this setting, other carboplatin-based combinations, such as gemcitabine and carboplatin, have been explored. This combination significantly improved PFS versus carboplatin alone in phase III trial (HR, 0.72; 95%CI, 0.58 to 0.90; P= .0031). however, OS was not significantly improved (HR, 0.96; 95% CI, 0.75 to 1.23; P = .735); the trial was not powered to detect a survival difference. Grade 3 to 4 hematologic toxicities were significantly more frequent in the combination arm. Thus, a need for other carboplatin combinations remains in PS ROC.
Pegylated liposomal doxorubicin (PLD) is an active drug in ROC as the efficacy has been demonstrated in CALYPSO trial.
CAYPSO is a large randomized phase III showing the noninferiority of the combination of pegylated liposomal doxorubicin (PLD) with carboplatin (CD) compared with CP in patients with PS ROC. In this trial, PFS for the CD arm was statistically superior to the CP arm (hazard ratio, 0.821; 95% CI, 0.72 to 0.94; P = .005); median PFS was 11.3 versus 9.4 months, respectively. Overall severe nonhematologic toxicity (36.8% v 28.4%; P = .01) leading to early discontinuation (15% v 6%; P = .001) occurred more frequently in the CP arm. More frequent grade 2 or greater alopecia (83.6% v 7%), hypersensitivity reactions (18.8% v 5.6%), and sensory neuropathy (26.9% v 4.9%) were observed in the CP arm; more hand-foot syndrome (grade 2 to 3, 12.0% v 2.2%), nausea (35.2% v 24.2%), and mucositis (grade 2-3, 13.9% v 7%) in the CD arm.
Moreover, recent subgroup analysis of CALYPSO trial had reported that CD had a more favorable risk-benefit profile than CP in patients with partially platinum-sensitive ROC (patients with a treatment-free interval of \>6 and ≤12 months). The hazard ratio for PFS was 0.73 (95% CI: 0.58-0.90; P = 0.004 for superiority) in favor of CD.
On the basis of the results of CALYPSO trial, Korea Food \& Drug Administration (KFDA) has approved and reimbursed the use of PLD in patients with PS ROC since August 2014. From then, approximately 700 patients with PS ROC have been treated with PLD in Korea.
The majority of patients enrolled in CALYPSO have 1 prior treatment, however, CD has been used in diverse setting of ROC in Korea. Therefore, the effectiveness and safety of the PLD combination should be still evaluated in the real clinical practice in Korea. To fulfill the gap of knowledge between clinical trials and actual clinical practice, we perform a multicenter, retrospective, observational study of CD therapy in the second line setting of PS ROC. | ArmGroups: [{'label': 'pegylated liposomal doxorubicin + carboplatin', 'description': 'carboplatin area under the curve \\[AUC\\] 5 plus pegylated liposomal doxorubicin (PLD) 30 mg/m2 every 4 weeks', 'interventionNames': ['Drug: pegylated liposomal doxorubicin (PLD) + carboplatin (CD)']}, {'label': 'paclitaxel + carboplatin', 'description': 'carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks', 'interventionNames': ['Drug: carboplatin + paclitaxel (CP)']}] | Interventions:[{'type': 'DRUG', 'name': 'pegylated liposomal doxorubicin (PLD) + carboplatin (CD)', 'description': 'carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks for at least 6 cycles', 'armGroupLabels': ['pegylated liposomal doxorubicin + carboplatin']}, {'type': 'DRUG', 'name': 'carboplatin + paclitaxel (CP)', 'description': 'carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks for at least 6 cycles', 'armGroupLabels': ['paclitaxel + carboplatin']}] | PrimaryOutcomes: [{'measure': 'Overall survival (OS)', 'description': 'OS was defined as the time from randomization to death of any cause. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive.', 'timeFrame': '36 months'}] | SecondaryOutcomes: [{'measure': 'Progression free survival (PFS)', 'description': 'PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria.', 'timeFrame': '3years'}, {'measure': 'Incidence of Treatment-Related Adverse Events', 'description': 'Safety and tolerability will be assessed in deaths, laboratory data, and vital signs. Number of participants with treatment-related adverse events as assessed by CTCAE version 4.0.', 'timeFrame': '36 months'}, {'measure': 'Response rate', 'description': 'Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) by Modified RECIST until progression reported. Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions.', 'timeFrame': '36 months'}] |
Title: A Prospective, Single-center, Single-arm, Exploratory Study on the Treatment of Recurrent Glioblastoma With Tumor Electric Fields Treatment System | Condition: Glioblastoma | Keywords: glioblastoma, tumor electric fields treatment | Summary: | Description: Subjects who have previously completed radiotherapy and at least two cycles of chemotherapy with imaging or pathological evidence of tumor recurrence will receive Tumor Electric Fields Treatment System. The main objective is to evaluate the safety of applying the Tumor Electric Fields Treatment System to subjects with recurrent GBM. | ArmGroups: [{'label': 'Tumor Electric Fields Treatment System', 'type': 'EXPERIMENTAL', 'description': 'Patients have a histologically confirmed diagnosis of supratentorial glioblastoma that is recurrent. All patients will receive Tumor Electric Fields Treatment System.', 'interventionNames': ['Device: Tumor Electric Fields Treatment System']}] | Interventions:[{'type': 'DEVICE', 'name': 'Tumor Electric Fields Treatment System', 'description': 'Patients wear two pairs of electrodes on the head for 19-22 hours a day. Each patient is required to wear the device as long as possible and not less than 6 months. The treatment has a two-day break for every four weeks.', 'armGroupLabels': ['Tumor Electric Fields Treatment System'], 'otherNames': ['ASCLU-300']}] | PrimaryOutcomes: [{'measure': 'The treatment-related adverse events', 'description': 'Number of patients who experienced a treatment-related adverse event.', 'timeFrame': '12 months'}, {'measure': 'Time to Progression', 'description': 'Time to progression of patients with recurrent glioblastoma.', 'timeFrame': '12 months'}, {'measure': 'Overall Survival Rate', 'description': 'Number of patients alive at 12 months.', 'timeFrame': '12 months'}] | SecondaryOutcomes: N/A |
Title: The Correlation Between the Moment of Bevacizumab theRapy initiatiOn and the Efficacy in patieNt With Metastatic Breast Cancer Treated With First Line Regimens Based On AvaStin | Condition: Breast Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Cohort'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Correlation between the time from start of chemotherapy to the start of Avastin treatment with progression-free survival', 'timeFrame': '60 months'}] | SecondaryOutcomes: [{'measure': 'Overall survival', 'timeFrame': '60 months'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': '60 months'}] |
Title: Pre-emptive Cycline Treatment on Cetuximab-induced Skin Toxicity in Patients With Metastatic Colorectal Cancer Treated With an Intensified FOLFIRI. | Condition: Colorectal Cancer Metastatic, Skin Toxicity | Keywords: Metastatic Colorectal Cancer, K-RAS wild-type, FOLFIRI, Cetuximab | Summary: | Description: Cetuximab, an Epidermal Growth Factor Receptor (EGFR) inhibitor, has shown to improve FOLFIRI efficacy up to 59.3% OR, in wild KRAS patients with advanced colorectal cancer. Skin toxicity occurs in 81.6% of patients as an acne-like skin rash developed on the face and the trunk inducing pain, decreasing quality of life and drug compliance. Over 104 patients enrolled in a phase II clinical trial sponsored by Center Paul Papin (NCT 00 559741), a grade \> or = 2 cetuximab-acneiform rash occured in 51 patients (49%). In this trial Cetuximab was combined with a FOLFIRI intensified (5-FU intensification based on pharmacokinetics and pharmacogenetic studies of UGT1A1 status and DPD). Until now, no pre-emptive skin toxicity treatment with cycline has been demonstrated. Because of cycline's anti inflammatory properties and their use in inflammatory acne, cycline could prevent cetuximab-induced skin rash. In a randomized double-blind placebo-controlled phase III trial, Jatoi et al., failed to highlight any cycline effect on 61 patients. On the other hand, the STEPP study (95 pts) showed the impact of cycline to prevent panitumumab related skin toxicities. Our primary objective is to reduce the incidence of grade \> or = 2 acne-like skin rash by 30% with a 6 weeks pre-emptive cycline treatment in patients with metastatic colorectal cancer undergoing cetuximab therapy. | ArmGroups: [{'label': 'Arm A', 'type': 'EXPERIMENTAL', 'description': 'Intensified FOLFIRI plus Cetuximab + Doxycycline 100 mg daily per os to start 7 days before Cetuximab for 6 weeks + skin moisturizers (Dexeryl), sun protection.', 'interventionNames': ['Drug: Doxycycline', 'Drug: Cetuximab']}, {'label': 'Arm B', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intensified FOLFIRI plus Cetuximab + skin moisturizers (Dexeryl), sun protection.', 'interventionNames': ['Drug: Cetuximab']}] | Interventions:[{'type': 'DRUG', 'name': 'Doxycycline', 'description': 'Doxycycline 100 mg daily per os to start 7 days before Cetuximab for 6 weeks.', 'armGroupLabels': ['Arm A']}, {'type': 'DRUG', 'name': 'Cetuximab', 'description': '500 mg/m² IV infusion of 60 minutes every 15 days', 'armGroupLabels': ['Arm A', 'Arm B']}] | PrimaryOutcomes: [{'measure': 'reduction of Grade > or = 2 acne-like skin rash by 30%', 'description': 'Skin tolerance will be assessed by a dermatologist at each cycle and NCI CTCAE v4.0 will be use for grading. Skin standardized photographs will be done at every cycle and a central double blind review wil be planned. Time to first occurence of grade \\> or =2 skin toxicity will be assessed, and specificity.', 'timeFrame': '6 weeks of pre-emptive cycline treatment'}] | SecondaryOutcomes: [{'measure': 'skin tolerance assessment', 'description': 'Skin tolerance will be assessed weekly by a dermatologist from C1 to C3, and biweekly from C4 to C6 and NCI CTCAE v4.0 will be use for grading. All grade \\> or = 1 skin and hair/nails toxicities will be reported. Time to most severe skin toxicity will be assessed. Quality of life questionnaires with a skin interest (DLQI) will be evaluated at baseline and at each cycle.', 'timeFrame': 'Until the end of Cetuximab treatment'}, {'measure': 'Non skin toxicities assessment', 'description': 'For non skin toxicities, only grade \\> or = 3 will be reported.', 'timeFrame': 'Until the end of chemotherapy treatment'}, {'measure': 'Efficacy Objective Response (OR) assessment', 'description': 'Efficacy OR (Complete Response + Partial Response) will be assessed by the investigator with usual tumoral evaluation. Tumoral evaluation will be assessed with the same exam throughout the trial.', 'timeFrame': 'Until the end of chemotherapy treatment'}, {'measure': 'Biological correlation with response and survival', 'description': 'Biological correlation with response and survival will be tested for KRAS, BRAF, PI3K,PTEN, epiregulin, amphiregulin, IGF1, Syndecan-1, UBE2C, EGFR polymorphism.', 'timeFrame': '3 years'}, {'measure': 'Time To Progression and Overall Survival', 'timeFrame': '3 years'}, {'measure': 'Resectability rate', 'timeFrame': 'Until the end of chemotherapy treatment'}] |
Title: Profiling the Intratumoral Microbiome of Pancreatic Ductal Adenocarcinoma Based on EUS-FNB Tissue Samples and Exploring Its Impact on Tumor Diagnosis and Prognosis. | Condition: Pancreatic Cancer, EUS-FNB, Intratumoral Microbiota, Diagnosis, Prognosis | Keywords: pancreatic cancer, EUS-FNB, intratumoral microbiota, diagnosis, Prognosis | Summary: | Description: N/A | ArmGroups: N/A | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Differences in Microbiome Diversity and Abundance Between Pancreatic Ductal Adenocarcinoma (PDAC) and Non-Cancerous Tissues', 'description': 'Using 2bRAD-M metagenomic sequencing technology, the study measures and compares bacterial species, quantity, and diversity between PDAC and non-cancerous tissues. This analysis evaluates the relationship between these microbial characteristics and the occurrence and progression of PDAC, aiming to uncover the potential role of the microbiome in the disease process.', 'timeFrame': '2 years'}] | SecondaryOutcomes: N/A |
Title: Feasibility Study of Lung Cancer Screening in the Flemish Region, the ZORALCS Study | Condition: Lung Cancer, Nonsmall Cell, Lung Cancer, Smoking Cessation, Lung Cancer, Small Cell | Keywords: Lung Cancer Screening, Lung Cancer, Smoking Cessation | Summary: | Description: A four year prospective non-randomized feasibility implementation study for lung cancer screening in a targeted high-risk population of heavy (ex-)smokers by low-dose CT, combined with a smoking cessation intervention. It will be coordinated by a consortium of researchers from UZA and UAntwerpen.
Lung cancer (LC) remains the leading cause of cancer mortality, worldwide and in Belgium. Prevention and early detection are considered the cornerstones to increase the chances of successful treatment and improved outcomes. There is strong scientific evidence that screening for lung cancer through an annual low-dose CT scan (LDCT) in a high-risk population of (ex-)smokers significantly reduces lung cancer mortality and is cost-effective. This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone (ELZ) South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation. Besides, other indicators of compliance, quality and turn-around-time will be estimated. It will give insights in the feasibility and potential challenges of implementing a LDCT lung cancer screening program in our region. This implementation project is in line with the European Commission Council recommendation of December 2022 to explore the feasibility and effectiveness of LDCT in a high-risk population. Findings from this study will contribute valuable evidence for policymakers and stakeholders. Furthermore, an implementation pilot is a prerequisite for a future high-quality population-based screening program. | ArmGroups: [{'label': 'High-risk (ex-) smokers', 'type': 'EXPERIMENTAL', 'description': 'Prevention and early detection of lung cancer are considered the cornerstones to increase the chances of successful treatment and improved outcomes. There is strong scientific evidence that screening for lung cancer through an annual low-dose CT scan (LDCT) in a high-risk population of (ex-)smokers significantly reduces lung cancer mortality and is cost-effective. This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone (ELZ) South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation.', 'interventionNames': ['Radiation: Low-dose CT scan', 'Behavioral: Smoking Cessation']}] | Interventions:[{'type': 'RADIATION', 'name': 'Low-dose CT scan', 'description': 'Participants get an annual low-dose CT scan in UZA', 'armGroupLabels': ['High-risk (ex-) smokers']}, {'type': 'BEHAVIORAL', 'name': 'Smoking Cessation', 'description': 'Smoking cessation campagnes', 'armGroupLabels': ['High-risk (ex-) smokers']}] | PrimaryOutcomes: [{'measure': 'Participation rate of eligible high-risk (ex-)smokers in ELZ-ZORA', 'description': 'Enrollment rate of eligible responders attending at least one LDCT procedure - Measured by descriptive statistics (discrete data)', 'timeFrame': '2 years'}] | SecondaryOutcomes: [{'measure': 'Responders', 'description': 'Number of candidates responding to the invitation - measured by descriptive statistics (discrete data)', 'timeFrame': '2 years'}, {'measure': 'Number of true and false positive nodules', 'description': 'Number of true and false positive nodules detected irequiring further work-up. Measured by descriptive statistics (discrete data)', 'timeFrame': '2 years'}, {'measure': 'Impact of smoking cessation intervention', 'description': 'Number of smoking participants having attended a smoking cessation intervention. Measured by descriptive statistics (discrete data)', 'timeFrame': '2 years'}, {'measure': 'Success of smoking cessation intervention', 'description': 'Number of smoking participants having quit smoking 1 year after enrollment. Measured by descriptive statistics (discrete data)', 'timeFrame': '2 years'}, {'measure': 'Evaluation of shared decision making tool', 'description': 'Evaluation of shared decision making tool by a questionnaire', 'timeFrame': '2 years'}] |
Title: A Phase II, Open-label, Single-arm, Multi-center Clinical Trial of Rivoceranib in Patients With Metastatic Thymic Epithelial Tumor | Condition: Thymic Epithelial Tumor | Keywords: | Summary: | Description: Thymic epithelial tumors (TET) are tumors of the thymus gland, which plays a pivotal role in adaptive immunity, and are classified as thymoma, thymic carcinoma, and thymic neuroendocrine tumor. Although it is the most common neoplasm of the anterior mediastinum, it is a rare cancer with an incidence of 0.15 cases per 100,000 people per year in the United States and 1.7 cases per 1,000,000 people per year in Europe. For surgically inoperable thymic epithelial tumors, first-line treatment is based on cytotoxic anticancer drugs. In this case, combinations such as Paclitaxel/Carboplatin or Cyclophosphamide, Adriamycin, Cisplatin (CAP) are mainly used as first-line treatment, but their therapeutic effect is still limited to less than 40%, and they also have very high toxicity. In the event of resistance to first-line therapy, there are a number of treatment options available, including Sunitinib, Pemetrexed, Everolimus, Paclitaxel, Gemcitabine based regimens, Lenvatinib, and Pembrolizumab. Lenvatinib, a representative agent with a similar mechanism of action to rivoceranib, has also shown excellent clinical results in thymic epithelial tumors. Lenvatinib, which targets various kinases in addition to the Vascular Endothelial Growth Factor Receptor (VEGFR), was used in a total of 42 patients, resulting in a partial response in 38% of patients and stable disease in 57% of patients. Rivoceranib is a selective inhibitor of VEGFR-2 and is currently approved and marketed in China for the treatment of gastric and liver cancer. Rivoceranib has similar targets to Lenvatinib and Sunitinib, and this study is expected to show clinical benefits when used in thymic epithelial tumors (TET), providing additional treatment opportunities for patients in the absence of targeted therapies currently covered by domestic insurance in the second-line setting. | ArmGroups: [{'label': 'single arm', 'type': 'EXPERIMENTAL', 'description': 'Rivoceranib 700 mg once daily by mouth. Rivoceranib should be given at the same time each day, with or without meals. Swallow the tablet whole. Do not chew, crush, or split the tablet.\n\nReceive study medication until there is evidence of disease progression, intolerable toxicity, withdrawal of consent by the patient, or in the judgment of the principal investigator that the study cannot continue due to inability to administer.\n\nTumor response will be assessed according to RECIST v1.1 criteria based on imaging studies (CT or MRI) measured every 8 weeks (±1 week) from C1D1 through 12 months and every 12 weeks (±1 week) after 12 months.', 'interventionNames': ['Drug: Rivoceranib']}] | Interventions:[{'type': 'DRUG', 'name': 'Rivoceranib', 'description': '700mg once daily', 'armGroupLabels': ['single arm']}] | PrimaryOutcomes: [{'measure': 'Objective response rate(ORR) Objective response rate(ORR)', 'timeFrame': '6 month after completion of enrollment'}] | SecondaryOutcomes: [{'measure': 'Progression-free survival(PFS)', 'timeFrame': 'up to 30 months'}, {'measure': 'Disease control rate(DCR)', 'timeFrame': 'up to 30 months'}, {'measure': 'Duration of response(DOR)', 'timeFrame': 'up to 30 months'}] |
Title: BrUOG 263: PSMA ADC for Recurrent Glioblastoma Multiforme (GBM): A Phase II Brown University Oncology Research Group Study | Condition: GBM, Glioblastoma Multiforme, Gliosarcoma | Keywords: GBM, Glioblastoma Multiforme, Gliosarcoma | Summary: | Description: PSMA expression has been demonstrated in the tumor neovasculature of Glioblastoma Multiforme (GBM) by immunohistochemical staining. Strong reactivity to the antibody component of PSMA ADC was observed in the endothelial cells of new tumor blood vessels in GBM. Since the endothelial cells are located on the luminal surface of blood vessels, PSMA ADC does not need to cross the blood brain barrier to reach its target. Following binding and internalization of PSMA ADC, the cytotoxic component of PSMA ADC will be released and destroy the neovasculature that supports tumor growth. Therefore, PSMA ADC may be an active treatment for GBM.
Bevacizumab, an inhibitor of angiogenesis, has been shown to be effective in improving progression-free survival as a single agent. Thus PSMA ADC, which targets tumor angiogenesis by a mechanism different from that of bevacizumab, may be a novel therapeutic modality for GBM.
A phase 2 study of PSMA ADC is proposed for patients with GBM that have progressed after standard treatment that includes radiation, temozolomide and bevacizumab. A phase 1 study of PSMA ADC in prostate cancer is ongoing and a phase 2 dose level of 2.5 mg/kg IV every 3 weeks has been defined. Treatment after bevacizumab failure for patients with GBM is a major unmet medical need. If activity were demonstrated in this trial, a definitive randomized study would be proposed. | ArmGroups: [{'label': 'PSMA ADC', 'type': 'EXPERIMENTAL', 'description': '2.5 mg/kg, IV, over 60 minutes every 3 weeks', 'interventionNames': ['Drug: PSMA ADC']}] | Interventions:[{'type': 'DRUG', 'name': 'PSMA ADC', 'description': '2.5 mg/kg, IV, over 60 minutes every 3 weeks', 'armGroupLabels': ['PSMA ADC']}] | PrimaryOutcomes: [{'measure': 'Response Rate (Progression) for Patients With Glioblastoma That Have Progressed After Prior Treatment That Has Included Radiation, Temozolomide and Bevacizumab.', 'description': 'The response assessment in neuro-oncology (RANO) will be used to define radiographic response.\n\n(PD): A \\>25% increase in tumor area (product of two diameters) OR appearance of a new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).', 'timeFrame': '3 months until progression, potentially up to 1 year'}] | SecondaryOutcomes: [{'measure': 'Number of Patients Who Experienced Toxicities (Adverse Events) Who Received PSMA ADC for Recurrent Glioblastoma.', 'description': 'Please note that toxicities outlined may not all be related to the treatment regimen.', 'timeFrame': 'at least every 3 weeks for a maximum of 30 post coming off drug, approximately 6 months'}] |
Title: EUS Staging Accuracy of Periampullary Neoplasms: a Retrospective Review | Condition: Periampullary Neoplasms | Keywords: EUS, periampullary neoplasms | Summary: | Description: N/A | ArmGroups: N/A | Interventions:N/A | PrimaryOutcomes: [{'measure': 'The presence of a biliary stent decreases EUS staging accuracy due to the intervening shadow artifacts'}] | SecondaryOutcomes: N/A |
Title: Pacritinib Prior to Transplant for Patients With Myeloproliferative Neoplasms (MPN) | Condition: Myeloproliferative Diseases | Keywords: Myeloproliferative Diseases, Myeloproliferative Neoplasms, MPN, Myelofibrosis, Polycythemia vera, PV, Essential thrombocythemia, Allogeneic stem cell transplantation, Allo TP, Pacritinib, Busulfan, Busulfex, Myleran, Questionnaires, Surveys, Phone calls | Summary: | Description: Study Drug Administration:
If you are found to be eligible to take part in this study, you will take pacritinib at about the same time each day by mouth, 2 times each day. Your doctor will tell you when to start and stop taking pacritinib. You may be able to take the drug for about 2-6 months depending on how you tolerate the drug and when your transplant date is. If you do not receive your transplant, you may be able to continue taking the study drug as long as the doctor thinks it is in your best interest.
You must swallow the capsules whole with a glass (about 8 ounces) of water. Do not open, break, or chew the capsules.
If you vomit or miss a dose of pacritinib, take your next dose of pacritinib at your regular time. Do not "make up" a missed or vomited dose.
You will be given a study drug diary to write down what time you take each dose of pacritinib. You need to bring the study drug diary, any leftover study drug, and any empty study drug containers with you to each study visit.
The dose of pacritinib you receive may be lowered or stopped, if the doctor thinks it is needed.
About 21 days after your last dose of pacritinib, you will given standard of care drugs and you will have an allogeneic stem cell transplant. Your doctor will explain this treatment and the stem cell transplant to you in more detail. You will be required to sign a separate consent form.
Study Visits:
One (1) time each month:
* You will have a physical exam.
* Blood (about 2 teaspoons) will be drawn for routine tests and to check your kidney and liver function.
* You will have an electrocardiogram (EKG -- a test that measures the electrical activity of the heart).
On Day 14 (+/- 2 days) of of Cycle 1, blood (about 2 teaspoons) will be drawn for routine tests and to check your kidney and liver function. You can have this blood drawn at a local lab or clinic that is closer to your home. The results will be sent to the study doctor at MD Anderson.
During Week 2 of Cycle 1, a member of the study staff will call to ask you about any symptoms you may be having. This call should last about 5-10 minutes.
Length of Study:
You will be on study for up to 1 year after the transplant. You may be taken off study early if the disease gets worse, if you have any intolerable side effects, of if you are unable to follow study directions.
Your participation on this study will be over after about 1 year of follow-up tests.
End-of-Study Visit:
Within about 7 days after your last dose of pacritinib, but before your stem cell transplant:
* You will have a physical exam and an ultrasound, MRI, or CT scan of your abdomen to measure your liver and spleen.
* You will have an EKG.
Before your transplant, you will have a bone marrow biopsy/aspiration to check the status of the disease.
Follow-Up Tests:
You will have follow-up visits at about 1, 3, 6, and 12 months after the transplant:
* You will complete 3 questionnaires about your symptoms and quality of life. It should take about 20-30 minutes to complete the questionnaires.
* At Month 3, you will have a physical exam and an ultrasound, MRI, or CT scan of your abdomen to measure your liver and spleen. This will be repeated at Month 12, if your doctor thinks it is needed.
* At Months 3 and 12, you will have a bone marrow biopsy/aspiration to check the status of the disease.
This is an investigational study. Pacritinib is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.
Up to 40 participants will be enrolled in this study. All will take part at MD Anderson. | ArmGroups: [{'label': 'Pacritinib + Allogeneic Stem Cell Transplantation', 'type': 'EXPERIMENTAL', 'description': 'Participants start Pacritinib 200 mg by mouth twice a day. Participants proceed to transplant after 60 days of Pacritinib but not more than 180 days. Pacritinib stopped 21 days prior to starting preparative regimen for standard of care stem cell transplantation (SOC Allo TP). SOC transplant conditioning with Fludarabine and Busulfan AUC of 4000 microMol-min per day providing that pharmacokinetic can be done, otherwise Busulfan dose given as a fixed dose of 100 mg/m2 daily for four days. Questionnaires about symptoms and quality of life completed at baseline, 1, 3, 6, and 12 months after transplant. Phone calls made by study staff to participant on second and third week of each month.', 'interventionNames': ['Drug: Pacritinib', 'Drug: Busulfan', 'Behavioral: Questionnaires', 'Behavioral: Phone Calls', 'Procedure: Allogeneic Stem Cell Transplantation', 'Drug: Fludarabine']}] | Interventions:[{'type': 'DRUG', 'name': 'Pacritinib', 'description': '200 mg by mouth twice a day for 60 days.', 'armGroupLabels': ['Pacritinib + Allogeneic Stem Cell Transplantation']}, {'type': 'DRUG', 'name': 'Busulfan', 'description': 'Busulfan AUC of 4000 microMol-min per day providing that pharmacokinetic can be done, otherwise Busulfan dose given as a fixed dose of 100 mg/m2 daily for four days.', 'armGroupLabels': ['Pacritinib + Allogeneic Stem Cell Transplantation'], 'otherNames': ['Busulfex', 'Myleran']}, {'type': 'BEHAVIORAL', 'name': 'Questionnaires', 'description': 'Questionnaires completed at baseline, 1, 3, 6, and 12 months after transplant.', 'armGroupLabels': ['Pacritinib + Allogeneic Stem Cell Transplantation'], 'otherNames': ['Surveys']}, {'type': 'BEHAVIORAL', 'name': 'Phone Calls', 'description': 'Phone calls made by study staff to participant on second and third week of each month.', 'armGroupLabels': ['Pacritinib + Allogeneic Stem Cell Transplantation']}, {'type': 'PROCEDURE', 'name': 'Allogeneic Stem Cell Transplantation', 'description': 'Allogeneic stem cell transplantation (Allo TP) 60 days after starting Pacritinib but not more than 180 days.', 'armGroupLabels': ['Pacritinib + Allogeneic Stem Cell Transplantation'], 'otherNames': ['Stem cell transplant']}, {'type': 'DRUG', 'name': 'Fludarabine', 'description': 'Fludarabine taken along with Busulfan as per standard of care as preparative regimen for allogeneic stem cell transplantation (Allo TP).', 'armGroupLabels': ['Pacritinib + Allogeneic Stem Cell Transplantation'], 'otherNames': ['Fludarabine phosphate', 'Fludara']}] | PrimaryOutcomes: [{'measure': 'Progression-free Survival (PFS)', 'description': 'The protocol was to enroll at least 21 evaluable participants, defined as patients who received Pacritinib for \\>/=60 days but less than 180 days. We enrolled four participants, however all four were not evaluable since no one was able to complete 60 days of Pacritinib.', 'timeFrame': 'participants who received Pacritinib for >/= 60 days but less than 180 days who undergo transplant with a matched related or at least 7/8 matched unrelated donor. The protocol was to evaluate progression free survival at one year.'}] | SecondaryOutcomes: N/A |
Title: Multicenter, Single-arm, Two Stage Phase II Trial of RAD001 (Everolimus) With Imatinib in Imatinib-resistant Patients With Progressive GIST | Condition: Progressive Gastrointestinal Stromal Tumor | Keywords: Progressive GIST, Resistance to Imatinib mesylate | Summary: | Description: N/A | ArmGroups: [{'label': 'RAD001 + Imatinib', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Imatinib mesylate']}] | Interventions:[{'type': 'DRUG', 'name': 'Imatinib mesylate', 'armGroupLabels': ['RAD001 + Imatinib']}] | PrimaryOutcomes: [{'measure': 'Tumor assessments should be performed by a CT or MRI scan after 4 months. Response to treatment with RAD001 plus Imatinib mesylate at 4 months (defined as progression-free survival (PFS) at 4 months).', 'timeFrame': 'at 4 months'}] | SecondaryOutcomes: [{'measure': 'Tolerability and safety assessed by AEs and SAEs. Objective tumor response rate (complete response [CR] and partial response [PR]) assessed by CT or MRI PFS at month 12 for patients with data available from follow up observation (optional)', 'timeFrame': 'At 12 months'}] |
Title: N/A | Condition: Prostate Carcinosarcoma | Keywords: MicroRNA, Prostate Carcinoma, PET-MR | Summary: | Description: N/A | ArmGroups: [{'label': 'High PSA (prostate-specific antigen) levels', 'interventionNames': ['Biological: High PSA levels']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'High PSA levels', 'armGroupLabels': ['High PSA (prostate-specific antigen) levels']}] | PrimaryOutcomes: [{'measure': 'Metastasis size and location', 'description': 'Location of metastasis by a report analyzing the pathological examination (PET-MR output).', 'timeFrame': '18 months'}] | SecondaryOutcomes: [{'measure': 'MicroRNA profile by using Nano-string technology validated by real time PCR', 'description': 'Validation of MicroRNA pattern by using real time PCR', 'timeFrame': '24 months'}] |
Title: Surgery and Virtual Reality: Interest of Virtual Reality in Oncology for Procedures Under Local Anesthesia in the Operating Room | Condition: Cancer | Keywords: Virtual reality, Pain control, Anxiety control, Local anesthesia, Surgery, Operating room, Analgesia Nociception Index (ANI) | Summary: | Description: Description of the modalities for recruiting :
During the preoperative consultation, the surgeon or anesthesiologist presents the study to the patient with a cancer requiring a surgery under local anesthesia. He gives the patient the consent form to participate in the study.
Once the consent form has been signed by the patient and the investigator, the investigator prescribes a screening test before surgery.
Patients registration and randomization :
Any patient who has signed an informed consent form (ICF) must be registered in the eCRF in order to be assigned a patient number.
Randomization will be centralized and performed via the eCRF. Patients will be randomly assigned (1:1) at the latest on the day of the surgery.
Experimental group : Local anaesthesia + virtual reality versus Control group : Anesthesia only.
Surgery period :
Regardless of the group, all patients :
* Will receive local anaesthesia according to the standard procedure required for the operation
* Hemodynamic parameters will be measured
* Will be questioned before, immediately after, and at a distance from the surgical procedure on their state of anxiety and immediately after the surgical procedure on the maximum pain felt during the procedure,
* Will be questioned on their satisfaction at the end of surgery.
ANI will be measured before, during and after the operation in patients included at the Saint Herblain site.
A virtual reality headset will be positioned on the patient before the start of the surgical procedure. | ArmGroups: [{'label': 'Local anesthesia + Virtual Reality', 'type': 'EXPERIMENTAL', 'description': 'In addition to local standard anaesthesia, patients benefit from a virtual reality session during the operation using a virtual reality headset', 'interventionNames': ['Device: Virtual reality headset']}, {'label': 'Local anesthesia alone', 'type': 'NO_INTERVENTION', 'description': 'Patients benefit only from a local anaesthesia is provided according to the standard procedure'}] | Interventions:[{'type': 'DEVICE', 'name': 'Virtual reality headset', 'description': 'Once the patient is on the operating table, the nurse proposes the different possible VR scenarios and installs the RV headset and an audio headset.', 'armGroupLabels': ['Local anesthesia + Virtual Reality']}] | PrimaryOutcomes: [{'measure': 'Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of the maximum subjective pain induced by the surgical procedure', 'description': 'Maximum subjective pain is measured by a numerical pain scale of 0 to 10. (0 : no pain ; 10 : maximum pain)', 'timeFrame': 'Immediately after surgery'}] | SecondaryOutcomes: [{'measure': 'Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of the objective pain induced by the surgical procedure in patients with Analgesia Nociception Index', 'description': 'Pain is evaluated in continuous by to the Analgesia Nociception Index (ANI) measured from the PhysioDoloris monitor (MDMS).\n\nIt is a unitless index between 0 and 100, which describes:\n\nPain: 0 ≤ ANI ≤ 40 Discomfort/anxiety: 40 \\< ANI ≤ 65 Comfort/well-being: 65 \\< ANI ≤ 100', 'timeFrame': 'in preoperative ; during the surgical procedure ; immediate postoperative'}, {'measure': 'Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of hemodynamic constants', 'description': 'Heart rate, blood pressure and respiratory rate measured by a multiparametric monitor type M540', 'timeFrame': 'in preoperative ; during the surgical procedure ; immediate postoperative'}, {'measure': 'Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of anxiety', 'description': 'Anxiety is measured by a visual analogue scale of 0 to 10. (0 : no anxiety ; 10 : maximum anxiety)', 'timeFrame': 'in preoperative ; immediate postoperative ; within 30 minutes after the surgery'}, {'measure': 'Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of patient satisfaction', 'description': 'Satisfaction is evaluated by a Lickert scale (Absolutely satisfied / Somewhat satisfied / Neither satisfied nor dissatisfied / Somewhat dissatisfied / Absolutely dissatisfied)', 'timeFrame': 'immediate postoperative'}, {'measure': 'Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of operator of the surgical procedure', 'description': 'Satisfaction is evaluated by a Lickert scale (Absolutely satisfied / Somewhat satisfied / Neither satisfied nor dissatisfied / Somewhat dissatisfied / Absolutely dissatisfied)', 'timeFrame': 'immediate postoperative'}] |
Title: Randomized Phase II Trial of Niraparib With Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I) | Condition: Prostate Adenocarcinoma, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8 | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. To establish the preferred dose of niraparib in combination with radiation and antiandrogen therapy (ADT). (Phase I) II. To compare the disease-free state, defined as PSA remaining \< 0.1 ng/ml at the end of ADT therapy in men with high risk prostate cancer treated with standard therapy with or without the addition of niraparib. (Phase IIR)
SECONDARY OBJECTIVES:
I. To further establish the safety and toxicity profile of standard treatment with radiation and androgen deprivation therapy specifically, two years from initiation of ADT, plus niraparib at the phase II dose.
II. To compare the overall survival, prostate cancer-specific survival, local/regional or distant progression, and distant metastatic disease rates of standard therapy with or without the addition of niraparib.
EXPLORATORY OBJECTIVES:
I. To identify genomic biomarkers of response to combination therapy with radiation, ADT and PARP inhibition.
OUTLINE: This is a phase I, dose-escalation study of niraparib, followed by a phase II study.
PHASE I: Patients receive niraparib orally (PO) once daily (QD) and receive standard of care gonadotrophin releasing hormone (GnRH) agonist androgen suppression therapy. Treatment with niraparib continues for 12 months, and GnRH agonist therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib and GnRH agonist, patients undergo standard of care intensity-modulated radiation therapy (IMRT) 5 days per week for about 6-9 weeks, depending on type of radiation therapy given, in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients are randomized to 1 of 2 arms:
ARM I: Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8-28 weeks after starting GnRH agonist, patients undergo IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months, and niraparib PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 3 years, then annually for 3 years. | ArmGroups: [{'label': 'Phase I (niraparib, GnRH, IMRT)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive niraparib PO QD and receive standard of care GnRH agonist androgen suppression therapy. Treatment with niraparib continues for 12 months, and GnRH agonist therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib and GnRH agonist, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks, depending on type of radiation therapy given, in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Biological: Gonadotrophin Releasing Hormone', 'Radiation: Intensity-Modulated Radiation Therapy', 'Drug: Niraparib']}, {'label': 'Phase II, Arm I (GnRH, IMRT)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8-28 weeks after starting GnRH agonist, patients undergo IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Biological: Gonadotrophin Releasing Hormone', 'Radiation: Intensity-Modulated Radiation Therapy']}, {'label': 'Phase II, Arm II (niraparib, GnRH, IMRT)', 'type': 'EXPERIMENTAL', 'description': 'Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months, and niraparib PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Biological: Gonadotrophin Releasing Hormone', 'Radiation: Intensity-Modulated Radiation Therapy', 'Drug: Niraparib']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'Gonadotrophin Releasing Hormone', 'description': 'Receive standard of care GnRH agonist androgen suppression therapy', 'armGroupLabels': ['Phase I (niraparib, GnRH, IMRT)', 'Phase II, Arm I (GnRH, IMRT)', 'Phase II, Arm II (niraparib, GnRH, IMRT)'], 'otherNames': ['AY-24031', 'D-His-6-Pro-8-NEt-LHRH', 'Follicle Stimulating Hormone-Releasing Factor', 'GN-RH', 'GnRH', 'Gonadoliberin', 'Gonadorelin', 'Gonadorelinum', 'gonadotropin-releasing hormone', 'Hoe- 471', 'LH-RF', 'LH-RH', 'LH/FSH-RF', 'LH/FSH-RH', 'LHRH', 'Luliberin', 'Luteinising Hormone-Releasing Factor', 'Luteinizing Hormone-Releasing Factor', 'luteinizing hormone-releasing hormone']}, {'type': 'RADIATION', 'name': 'Intensity-Modulated Radiation Therapy', 'description': 'Undergo standard of care IMRT', 'armGroupLabels': ['Phase I (niraparib, GnRH, IMRT)', 'Phase II, Arm I (GnRH, IMRT)', 'Phase II, Arm II (niraparib, GnRH, IMRT)'], 'otherNames': ['IMRT', 'Intensity Modulated RT', 'Intensity-Modulated Radiotherapy']}, {'type': 'DRUG', 'name': 'Niraparib', 'description': 'Given PO', 'armGroupLabels': ['Phase I (niraparib, GnRH, IMRT)', 'Phase II, Arm II (niraparib, GnRH, IMRT)'], 'otherNames': ['MK-4827', 'MK4827']}] | PrimaryOutcomes: [{'measure': 'Maintenance of disease-free state', 'description': 'Will be characterized by PSA values sustained below 0.1 ng/ml. A modified intent-to-treat analysis will be conducted. The proportion of patients disease-free at 24 months will be compared in the two treatment arms using a non continuity-corrected chi-square test. As a secondary analysis, a logistic regression model will be fit to adjust for the stratification factors (risk group and type of radiation therapy).', 'timeFrame': 'Up to 2 years following the start of antiandrogen therapy'}] | SecondaryOutcomes: [{'measure': 'Overall Survival', 'description': 'Will consist of comparison of Kaplan-Meier (Kaplan 1958) curves using a logrank test.', 'timeFrame': 'From randomization until death from any cause, assessed up to 3 years'}, {'measure': 'Prostate cancer-specific survival', 'description': 'Will consist of comparison of Kaplan-Meier (Kaplan 1958) curves using a logrank test.', 'timeFrame': 'From randomization until death from prostate cancer, assessed up to 3 years'}, {'measure': 'Pathologic Complete Response (pCR)', 'description': 'Will be assessed among patients undergoing 12-core biopsy. Will be compared using a chi-square test.', 'timeFrame': 'At 24 months'}, {'measure': 'Time to local/regional or distant progression', 'description': 'Cumulative incidence curves will be compared using the Fine-Gray test (Dignam 2008).', 'timeFrame': 'Up to 3 years'}, {'measure': 'Time to distant metastases', 'description': 'Cumulative incidence curves will be compared using the Fine-Gray test (Dignam 2008).', 'timeFrame': 'From randomization until detection of distant metastatic disease, assessed up to 3 years'}, {'measure': 'Biochemical Progression-Free Survival', 'description': 'Will be defined as PSA \\>= 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or death from prostate cancer. Will consist of comparison of Kaplan-Meier (Kaplan 1958) curves using a logrank test.', 'timeFrame': 'Up to 3 years'}, {'measure': 'Incidence of Adverse Events (Phase II)', 'description': 'Adverse event (AE) rates in the two treatment arms will be summarized by time of occurrence (early versus late), type, grade, and attribution to treatment. For each type of AE, the worst grade occurring during the early treatment period, late treatment period, or entire treatment period will be determined. For each time period, treatment group comparisons will be conducted using chi-square or Fisher exact tests.', 'timeFrame': 'Up to 3 years'}] |
Title: Clinical Research on Teratment of Gastrointestinal Cancer in the Preoperative by Propranolol | Condition: Gastrointestinal Cancer | Keywords: Gastrointestinal Cancer, Propranolol | Summary: | Description: N/A | ArmGroups: [{'label': 'placebo and propranolol', 'type': 'EXPERIMENTAL', 'description': 'We used propranolol and placebo as an control drug to treat with patients.', 'interventionNames': ['Drug: Propranolol']}] | Interventions:[{'type': 'DRUG', 'name': 'Propranolol', 'description': '0 or 1 were generated by using Random software. The patient entered the placebo group if number was 0; if the random number generated was 1, then entered the propranolol group.', 'armGroupLabels': ['placebo and propranolol'], 'otherNames': ['placebo']}] | PrimaryOutcomes: [{'measure': 'Tumor size will be measured.', 'description': "We used CT and Ki67 to confirm that the drug's affection.", 'timeFrame': 'Our experiment completed after patients took medicine for one week.'}] | SecondaryOutcomes: N/A |
Title: Microbiota and Metabolomics of Intestinal Type of Gastric Cancer in the Context of Atrophic Gastritis | Condition: Gastric Cancer | Keywords: | Summary: | Description: This study adopts a prospective cohort study. The expected recruitment time for all participants is 6 months, and all cases are cases who would receive magnifying endoscopy examination. The extent of atrophy and the presence of early gastric cancer are determined under magnifying endoscopy. Cases are chose into the gastric cancer group and atrophic gastritis group in a 1:1 ratio. There are 16 cases of intestinal type of gastric cancer under the background of atrophic gastritis, and 16 cases of atrophic gastritis without gastric cancer matched according to gender, age, and degree of gastric atrophy, totaling 32 cases. Analyze the characteristics of early gastric cancer under endoscopy, investigate the changes in microbiota and metabolomics of intestinal type of gastric cancer under the background of atrophic gastritis, and explore the relevant mechanisms. | ArmGroups: [{'label': 'the gastric cancer group', 'description': '16 cases of intestinal type of gastric cancer under the background of atrophic gastritis'}, {'label': 'the atrophic gastritis group', 'description': '16 cases of atrophic gastritis without gastric cancer matched according to gender, age, and degree of gastric atrophy'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Metabolomics results of lesions and atrophic gastritis.', 'description': 'liquid chromatograph mass spectrometer metabolic profling', 'timeFrame': '1year'}] | SecondaryOutcomes: [{'measure': 'microbiomics of lesions and atrophic gastritis.', 'description': '16SrRNA analysis', 'timeFrame': '1 year'}] |
Title: An Open Label Study To Investigate the Pharmacokinetics and Pharmacodynamics of Repeat Escalating Doses of the Oral AKT Inhibitor GSK2141795 by 18F FDG PET Analysis in Subjects With Ovarian Cancer | Condition: Solid Tumours | Keywords: Cancer, 18F FDG, PK, PET, Positron Emission Tomography, PD, AKT Inhibitor, GSK2141795 | Summary: | Description: N/A | ArmGroups: [{'label': 'Stage 1', 'type': 'EXPERIMENTAL', 'description': 'Three to six patients on a medium dose of GSK2141795 for four weeks', 'interventionNames': ['Drug: GSK2141795']}, {'label': 'Stage 2', 'type': 'EXPERIMENTAL', 'description': 'Nine to eighteen subjects on a low, medium or high dose of GSK2141795 for four weeks', 'interventionNames': ['Drug: GSK2141795']}] | Interventions:[{'type': 'DRUG', 'name': 'GSK2141795', 'description': 'GSK2141795 is an oral, low nanomolar pan-AKT kinase inhibitor that demonstrates activity in hematologic and solid tumor cell lines. It also delays tumor growth in a dose dependent manner in solid tumor xenograft mouse models', 'armGroupLabels': ['Stage 1', 'Stage 2']}] | PrimaryOutcomes: [{'measure': 'The amount of GSK2141795 in the blood (ng/ml) from baseline', 'timeFrame': '6 months'}] | SecondaryOutcomes: [{'measure': 'The net unidirectional uptake of FDG (Ki) from baseline', 'timeFrame': '6 months'}, {'measure': 'The change in size of tumor from baseline (RECIST Criteria)', 'timeFrame': '6 months'}] |
Title: Latent Mycobacterium Tuberculosis Infection Among Cancer Patients | Condition: Advanced Cancer | Keywords: Advanced Cancer, Solid Tumors, Latent Mycobacterium Tuberculosis, Tuberculin Skin Test, Tuberculosis, T-SPOT TB test, TB | Summary: | Description: TB AND TB TESTS:
Patients with cancer are considered "immunocompromised." This means that, because of the cancer and the cancer treatment, the immune system does not function normally, which decreases its ability to fight off infection and disease. This immunocompromised condition places these patients (who probably had been in contact with the TB bacteria, resulting in latent, or inactive, TB) at risk for active TB. Latent TB does not cause symptoms or signs of active TB infection. It is very important to identify patients who are at risk for developing active TB, so that they can receive timely treatment for TB.
The Tuberculin skin test (TST) is currently used to detect latent TB. The TST is considered to have low detection sensitivity, which means that it may not always detect latent TB, which may then turn into an active TB infection.
The T-SPOT.TB is a new test that researchers want to study to see whether it may be more effective and accurate than the TST at identifying patients at risk for developing active TB.
STUDY PARTICIPATION:
If you agree to take part in this study, you will have the following tests done and steps taken.
* You will have extra blood (about 1 to 2 teaspoons) drawn. It will be done at the same time as your routine clinic visit to M. D. Anderson or as a regular blood draw if you are already admitted in the hospital. This blood will be used to perform the T-SPOT. TB test.
If you have had a TST (or tuberculin skin test) performed at M. D. Anderson in the past 45 days, it may probably not be necessary to repeat the TST. However, the research staff will decide if you need to have a new TST.
You may have the TST performed before or after your blood is drawn. In any case, you will rest for 10 minutes after the blood draw.
* You will receive a fluid called tuberculin in order to have the TST performed. Tuberculin will be injected just beneath the surface of the skin on your forearm. You should then see a very small raised area of skin where the injection was given. This reaction will wear off in a few days.
* After 2-3 days (48-72 hours later), you will return to M. D. Anderson (if you are not in the hospital), and a health care professional will look at and measure any swelling or redness at the site of TST. The doctor will then learn if your TST result is positive or negative. If your TST is positive the study doctor will discuss it with , your primary doctor for further evaluation and treatment.
Although you will be informed about the TST result, you will not be informed about the T-SPOT. TB test result because the T-SPOT. TB test is just used for investigational purposes in this study and will not be used for diagnostic purposes. The study doctor will use the results of the T-SPOT. TB test to make research comparisons with the TST test results.
LENGTH OF STUDY:
Your participation will be over in this study once both TB tests have been performed and the TST has been checked by a health care professional.
This is an investigational study. The TST is FDA approved and commercially available. The T-SPOT.TB test is not FDA approved or commercially available. It is authorized for use in research only. Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson. | ArmGroups: [{'label': 'Latent Tuberculosis Infection', 'description': 'Patients with cancer at risk for developing active tuberculosis (TB).', 'interventionNames': ['Other: T-SPOT TB test']}] | Interventions:[{'type': 'OTHER', 'name': 'T-SPOT TB test', 'description': 'Extra blood draw, followed by ten minutes rest and the injection of Tuberculin subcutaneously on forearm.', 'armGroupLabels': ['Latent Tuberculosis Infection']}] | PrimaryOutcomes: [{'measure': 'Rate of Positive Results of T-SPOT.TB (%)', 'description': "Number participants with postitive T-SPOT.TB test results compared to total positive results, derived from Center for Disease Control (CDC) Criteria used for LTBI positive skin test (i.e. a tuberculin skin test (TST) with 5 mm or more of induration). For those individuals with \\>5 mm induration on TST, chest radiograph performed. Fisher's exact test used to assess the association between categorical variables and the testing results of T-SPOT.TB or TST.", 'timeFrame': 'Study period 2 Years'}] | SecondaryOutcomes: N/A |
Title: Assessment of the Blink (First) Impression Regarding the Presence of Cancer Within Colorectal Polyps | Condition: Colorectal Polyp, Colorectal Cancer, Colono | Keywords: | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'Presence of Blink impression features for cancer in colorectal polyps', 'description': '1. 20 LNPCPs will be collected from the UZ Ghent database (all LNPCPs, ICF present).\n2. A survey will be made where participant endoscopist will be informed about the study. They will here be asked for electronic consent.\n3. The survey asks for demographics of the participant endosopists (experience, country where they work).\n4. The last part of the survey is where the 20 images of the LNPCPs are shown. After evere image 4 questions are asked. Is this a colorectal polyp? (Yes/No)\n\n * Is your Blink (first) Impression that this polyp contains cancer? (Yes/No)\n * If "yes", why do you think that? (Free comment box)\n * What treatment would you recommend for this polyp? (piecemeal endoscopic mucosal resection/endoscopic submucosal disection/surgery)\n5. Study will be closed after 2 weeks.\n6. Data analysis'}] | PrimaryOutcomes: [{'measure': 'The accuracy of endoscopic assessment as to the risk of SMI within LNPCPs.', 'description': 'The accuracy of endoscopic assessment as to the risk of SMI within LNPCPs, using the Blink (first) impression when analysing images of LNPCPs.', 'timeFrame': 'Through study completion, Study is open for 2 weeks'}] | SecondaryOutcomes: [{'measure': 'Identifying the parameters of LNPCPs that prompt endoscopist to have a positive Blink impression for the presence of SMI.', 'description': 'Identifying the parameters of LNPCPs that prompt endoscopist to have a positive Blink impression for the presence of SMI.', 'timeFrame': 'Through study completion, Study is open for 2 weeks'}] |
Title: A Phase Ib/II Trial of Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER") | Condition: Breast Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Phase II: Arm A', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive HCQ, 600 mg BID, for 24 weeks.', 'interventionNames': ['Drug: Hydroxychloroquine (HCQ)', 'Drug: Gedatolisib']}, {'label': 'Phase II: Arm B', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive HCQ, 600 mg BID, for 24 weeks and GED x 2 weeks administered weekly, as an intravenous dose of 150 mg.', 'interventionNames': ['Drug: Hydroxychloroquine (HCQ)', 'Drug: Gedatolisib']}, {'label': 'Phase II: Arm C', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive HCQ, 600 mg BID, for 24 weeks and GED x 6 weeks administered weekly, as an intravenous dose of 150 mg.', 'interventionNames': ['Drug: Hydroxychloroquine (HCQ)', 'Drug: Gedatolisib']}, {'label': 'Phase II: Arm D', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive HCQ, 600 mg BID, for 24 weeks and GED x 12 weeks administered weekly, as an intravenous dose of 150 mg.', 'interventionNames': ['Drug: Hydroxychloroquine (HCQ)', 'Drug: Gedatolisib']}, {'label': 'Phase Ib Arm', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive HCQ, 600 mg BID, and GED, administered weekly as an intravenous dose of 150 mg, for 6 weeks.', 'interventionNames': ['Drug: Hydroxychloroquine (HCQ)', 'Drug: Gedatolisib']}] | Interventions:[{'type': 'DRUG', 'name': 'Hydroxychloroquine (HCQ)', 'description': 'All patients will receive HCQ at a dose of 600 mg orally twice daily. This dose is the same in both phase Ib and phase II portions of the protocol. Capsules of HCQ are available in 200 mg strength, thus patients will initially start with 3 capsules twice daily for a total of 6 capsules per day. HCQ will be administered in divided doses (BID). When taking HCQ twice daily, the two daily doses should be taken 12 hours apart as close to 9am and 9pm as possible. Patients receiving antacids, sucralfate, cholestyramine, and/or bicarbonate should have the HCQ drug dose administered at least 1 hour before or 2 hours after these medications. Hydroxychloroquine will be obtained from the UPENN Investigational Drug Service (IDS).', 'armGroupLabels': ['Phase II: Arm A', 'Phase II: Arm B', 'Phase II: Arm C', 'Phase II: Arm D', 'Phase Ib Arm']}, {'type': 'DRUG', 'name': 'Gedatolisib', 'description': 'Gedatolisib will be administered intravenously on a weekly dosing schedule at 150 mg IV.\n\nWithin 3 days prior to GED dosing the patient must have an ANC \\>1.0 x 109/L and platelet count \\> 75 x 109/L. If hematologic toxicity persists, treatment should be delayed by one week and the complete blood cell count with differential and platelet count repeated. Treatment may be delayed for up to 4 consecutive weeks (28 days). If after 28 days of delay all hematologic toxicity has still not resolved to normal and non-hematologic toxicity has not resolved to \\<grade 1 then any further treatment with GED should be stopped.', 'armGroupLabels': ['Phase II: Arm A', 'Phase II: Arm B', 'Phase II: Arm C', 'Phase II: Arm D', 'Phase Ib Arm']}] | PrimaryOutcomes: [{'measure': 'Frequency of Adverse Events', 'description': 'Frequency of \'a priori\' defined "severe" adverse events and any adverse event by NCI CTCAE v5 criteria (Phase Ib)', 'timeFrame': 'Approximately 4 Years'}, {'measure': 'Response to Treatment', 'description': '"Response" to treatment is defined by a greater than or equal to 50% reduction in number of disseminated tumor cells (DTCs) at 24 weeks compared to baseline (Phase II)', 'timeFrame': 'Approximately 6 Months'}] | SecondaryOutcomes: [{'measure': 'Occurrence of Adverse Events', 'description': 'NCI CTCAE v5 criteria (Phase II)', 'timeFrame': 'Approximately 6 Months'}, {'measure': 'Recurrence After Treatment', 'description': 'Recurrence Free Survival (RFS)', 'timeFrame': '3 Years'}] |
Title: Prospective Randomized Trial of Incisionless Versus Conventional Laparoscopic Colectomy for Left-sided Colonic Tumors | Condition: Pain,, Postoperative Wound Complication | Keywords: pain score, complication | Summary: | Description: For the left-sided colorectal cancer, the investigators performed colectomy with primary anatomosis. Currently the investigators have two methods of minimal access approach to the abdominal cavity in order to complete this operation:
1. Conventional Laparoscopic colectomy The operation is completed by laparoscopic instruments using video laparoscopy. At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler. Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis
2. Incisionless Laparoscopic Colectomy Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the Transanal Endoscopic Operation (TEO) device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy. Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.
These two operations are essentially identical except for the surgical access for the delivery of specimen and insertion of anvil. Laparoscopic colectomy and the use of Transanal Endoscopic Operation(TEO)device have been practiced in the United States and Europe for over 10 years. Large scale studies in the literature have demonstrated the safety and benefits of laparoscopic colectomy for colonic tumors and the oncological outcomes have not shown to be inferior to open approach. With the use of TEO device, the investigators can perform laparoscopic colectomy without abdominal incision for those early left-sided colonic tumors and thus it can eliminate the wound-related complications theoretically. In order to find out which one is a better procedure, the investigators are carrying out a clinical trial to compare the two surgical options in their short-term and long term outcomes.The results of this study may have an impact on the care of similar patients in the future. | ArmGroups: [{'label': 'incisionless laparoscopic colectomy', 'type': 'ACTIVE_COMPARATOR', 'description': 'incisionless laparoscopic colectomy: Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the TEO device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy. Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.', 'interventionNames': ['Procedure: incisionless laparoscopic colectomy']}, {'label': 'conventional laparoscopic colectomy', 'type': 'ACTIVE_COMPARATOR', 'description': 'conventional laparoscopic colectomy: The operation is completed by laparoscopic instruments using video laparoscopy. At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler. Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis', 'interventionNames': ['Procedure: conventional laparoscopic colectomy']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'incisionless laparoscopic colectomy', 'description': 'Arm 1:Incisionless Laparoscopic Colectomy Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the TEO device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy. Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.', 'armGroupLabels': ['incisionless laparoscopic colectomy']}, {'type': 'PROCEDURE', 'name': 'conventional laparoscopic colectomy', 'description': 'Arm 2: Conventional Laparoscopic colectomy The operation is completed by laparoscopic instruments using video laparoscopy. At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler. Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis', 'armGroupLabels': ['conventional laparoscopic colectomy']}] | PrimaryOutcomes: [{'measure': 'pain score', 'description': 'participants will be followed for the pain score during the duration of hospital stay, an expected average of 1 week', 'timeFrame': 'average of 1 week'}] | SecondaryOutcomes: [{'measure': 'wound complication', 'description': 'The patient will be followed for up to 30 days after the operation or till occurrence of event', 'timeFrame': 'up to 30 days after the operation'}] |
Title: Efficacy of Olanzapine on Weight Gain in Women with Advanced Stage Gynecologic Cancer Receiving Paclitaxel and Carboplatin Combination Chemotherapy : a Double Blind, Placebo-controlled Randomized Trial | Condition: Weight Gain | Keywords: | Summary: | Description: -Proprotion of pateints in advanced stage gynecologic cancer who recieving paclitaxel and carboplatin chemotherapy gain weight on olanzapine or placebo | ArmGroups: [{'label': 'Olanzapine', 'type': 'EXPERIMENTAL', 'description': 'Olanzapine 5 mg oral OD', 'interventionNames': ['Other: weight gain each group']}, {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo', 'interventionNames': ['Other: weight gain each group']}] | Interventions:[{'type': 'OTHER', 'name': 'weight gain each group', 'description': 'weight gain after 12 Weeks', 'armGroupLabels': ['Olanzapine', 'Placebo'], 'otherNames': ['body weight']}] | PrimaryOutcomes: [{'measure': 'Efficacy of olanzapine on weight gain in advanzed stage gynecologic cancer recieving paclitexal and carboplatin chemotherapy', 'description': 'proprotion of pateints gain weight after intervention (olanzapine or placebo) by monitor weight before and after get intervention', 'timeFrame': '12 weeks after intervention'}] | SecondaryOutcomes: N/A |
Title: Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer | Condition: Prostate Cancer | Keywords: stage IV prostate cancer, recurrent prostate cancer, adenocarcinoma of the prostate | Summary: | Description: OBJECTIVES:
Primary
* Determine the palliative response rate in patients with hormone-resistant prostate cancer treated with mitoxantrone hydrochloride vs etoposide vs vinorelbine ditartrate as second-line therapy.
Secondary
* Determine the duration of palliative response in patients treated with these regimens.
* Determine the biological response (PSA \> 50%) in these patients.
* Determine the time to progression (biological and clinical) in these patients.
* Determine the overall survival of these patients.
* Determine the quality of life and the impact on autonomy of patients over 70 years of age.
* Determine the toxicity of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive mitoxantrone hydrochloride IV over 5 minutes once a week for 3 weeks.
* Arm II: Patients receive oral etoposide twice daily on days 1-14.
* Arm III: Patients receive oral vinorelbine ditartrate once daily on days 1 and 8 and oral prednisone once daily on days 1-21.
Treatment in all three arms repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'etoposide'}, {'type': 'DRUG', 'name': 'mitoxantrone hydrochloride'}, {'type': 'DRUG', 'name': 'prednisone'}, {'type': 'DRUG', 'name': 'vinorelbine tartrate'}] | PrimaryOutcomes: [{'measure': 'Palliative response rate'}] | SecondaryOutcomes: [{'measure': 'Duration of palliative response'}, {'measure': 'Biological response'}, {'measure': 'Tumor response as assessed by RECIST criteria'}, {'measure': 'Time to progression'}, {'measure': 'Overall survival'}, {'measure': 'Quality of life as assessed by QLQ-PR25'}, {'measure': 'Impact on autonomy in patients > 70 years of age'}, {'measure': 'Toxicity'}] |
Title: A Phase 2, Randomized Study of Proscavax, a PSA/IL-2/GM-CSF Vaccine, in Treatment-naive Patients With Clinically Localized Prostate Cancer Versus an Active Surveillance Strategy | Condition: Prostate Cancer | Keywords: Prostate Specific Antigen, Immunotherapy | Summary: | Description: This study will have 2 arms and patients will be randomized 2:1 into the Proscavax treatment arm (Arm 1) versus the active surveillance arm (Arm 2).
In study Arm 1, 6 doses of the vaccine will be administered intradermally at weeks 1, 2, 3, 7, 11, and 15, followed by maintenance booster injections once every month which will alternate between low dose IL-2 alone (at weeks 19, 27 and 35) and Proscavax vaccine (at weeks 23, 31, 39) for 6 months.
In study Arm 2, patients will undergo active surveillance and will not receive any Proscavax vaccine treatment. | ArmGroups: [{'label': 'Arm 1 - Proscavax vaccine treatment', 'type': 'EXPERIMENTAL', 'description': 'In this arm, during the first 4 months of induction treatment, 6 doses of the Proscavax vaccine will be administered intradermally at weeks 1, 2, 3, 7, 11, and 15, followed by maintenance booster injections once every month which will alternate between low dose IL-2 alone (at weeks 19, 27 and 35) and Proscavax vaccine (at weeks 23, 31, 39) for 6 months.', 'interventionNames': ['Biological: Proscavax']}, {'label': 'Arm 2 - Active Surveillance', 'type': 'NO_INTERVENTION', 'description': 'In this arm, patients will undergo active surveillance and will not receive any Proscavax vaccine treatment.'}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'Proscavax', 'description': 'Proscavax is a prostate cancer vaccine which combines the prostate antigen PSA with immune stimulatory cytokines (IL-2 and GM-CSF).', 'armGroupLabels': ['Arm 1 - Proscavax vaccine treatment']}] | PrimaryOutcomes: [{'measure': 'Prostate cancer progression measured by PSA test', 'description': 'Determine prostate cancer progression in patients receiving Proscavax vaccine (Arm 1) versus patients on active surveillance (Arm 2) by measuring change in PSA levels in patients in both arms', 'timeFrame': 'At pre-study, and then every 3 months till 2 years, starting at week 7 for both arms'}, {'measure': 'Prostate cancer progression measured by digital rectal examination (DRE)', 'description': 'Determine prostate cancer progression in patients receiving Proscavax vaccine (Arm 1) versus patients on active surveillance (Arm 2) by performing digital rectal examination (DRE) on patients in both arms', 'timeFrame': 'At pre-study and then every 6-months for 2 years'}, {'measure': 'Prostate cancer progression measured by prostate Biopsy', 'description': 'Determine prostate cancer progression in patients receiving Proscavax vaccine (Arm 1) versus patients on active surveillance (Arm 2) by performing prostate biopsy on patients in both arms', 'timeFrame': 'At pre-study and then every 12-months for 2 years'}] | SecondaryOutcomes: [{'measure': 'PSA doubling time', 'description': 'Determine the time for the PSA level to double', 'timeFrame': 'At pre-study, and then every 3 months till 2 years, starting at week 7 for both arms'}, {'measure': 'Assessment of Adverse Events', 'description': 'Confirm safety and tolerability of Proscavax vaccine', 'timeFrame': 'From first injection until 30 days past the 24-month assessments'}] |
Title: Sequential Hypofractionated Radiotherapy Followed by Anti-PD-L1 Atezolizumab for Recurrent or Refractory Small Cell Lung Cancer | Condition: Small Cell Lung Cancer Recurrent | Keywords: | Summary: | Description: Small cell lung cancer (SCLC), accounting for 10% of all lung cancers (Torre et al., 2015), shows poor outcomes with 7-10 months of median survival in advanced cases (Jett et al., 2013). Despite novel treatment strategies including targeted therapy and immunotherapy for non-small cell lung cancer (NSCLC) have been introduced, the treatment options for SCLC still remain limited. Many clinical trials, which tested the efficacy of molecular targeted agents for SCLC, failed to show clinical benefit compared with conventional platinum-based chemotherapy (Koinis et al., 2016). Nevertheless, recent studies demonstrated that immunotherapy using anti-CTLA-4 or anti-PD1 monoclonal antibody can be novel therapeutic strategies for SCLC (Ott et al., 2015; Reck et al., 2013; SJ et al., 2015).
In recent years, many studies have shown that radiation therapy can be a useful treatment as a combining treatment with immunotherapy. The abscopal effect refers to the ability of radiation delivered radiation delivered to a local site to treat the other diseases outside radiation field (Tang et al., 2014). A recent study described that abscopal effect was observed in a malignant melanoma patient treated with CTLA4 antagonist and radiotherapy (Postow et al., 2012). Moreover, an animal study presented that blockade of PD-L1 and ionizing radiation showed synergism (Deng et al., 2014). Based on these emerging evidences, the investigators hypothesized that local radiation therapy can enhance the effect of anti-PD-L1 monoclonal antibody through increasing T-cell effector function against tumors. Atezolizumab, which is a humanized anti-PD-L1 monoclonal antibody, act as an inhibitor the interaction between PD-L1 and PD-1, and eventually restore suppressed T-cell immunity leading elimination of cancer cells. In this study, the investigators will investigate the combining effect of hypofractionated-sublethal dose of radiation therapy followed by anti-PD-L1 monoclonal antibody, atezolizumab, for SCLC patients who are recurrent or refractory for initial platinum-based chemotherapy.
Based on these emerging evidences, the investigators hypothesized that local radiation therapy can enhance the effect of anti-PD-L1 monoclonal antibody through priming T-cell effector function against cancer cells. Described as above, the investigators concluded that modest dose of radiation to local site prior to immunotherapy is the best to enhance T-cell-mediated immunity. | ArmGroups: [{'label': 'Interventions', 'type': 'EXPERIMENTAL', 'description': 'Atezolizumab', 'interventionNames': ['Drug: Atezolizumab']}] | Interventions:[{'type': 'DRUG', 'name': 'Atezolizumab', 'description': 'Patients undergo hypofractionated radiation therapy with 24 Gy over 4 fractions in days 1-4 of 1st cycle of atezolimumab and receive Atezolizumab 1200 mg fixed dose via intravenous on day 1 of each 3-week cycle until disease progression or unacceptable toxicity occurs.', 'armGroupLabels': ['Interventions'], 'otherNames': ['Tecentriq']}] | PrimaryOutcomes: [{'measure': 'ORR', 'description': 'Objective Response rate using RECIST v1.1', 'timeFrame': 'through study completion, and average of 1 years'}] | SecondaryOutcomes: [{'measure': 'PFS', 'description': 'Progression Free Survival', 'timeFrame': 'From date of enroll until the date of first documented progression or date of death from any cause, whichever came first, assessed up to at least 12 months'}] |
Title: National French Cohort Evaluating Predictive Factors of Resistance to Immunotherapy in Patients With MSI Metastatic Colorectal Cancer | Condition: Colorectal Cancer Metastatic, Microsatellite Instability-High Colorectal Cancer | Keywords: immunotherapy resistance | Summary: | Description: The primary endpoint is the identification of predictive factors of resistance to pembrolizumab in first-line treatment of MSI and/or dMMR metastatic colorectal cancer
CORESIM is a retrospective and prospective multicenter national French cohort. National recruitment will be carried out in all French centers, including the FFCD, AGEO, GERCOR, and UNICANCER, representing more than 150 centers and most French sites, public and private hospitals.
In France, pembrolizumab for first-line treatment of patients with MSI mCRC was accessible via its compassionate use in February 2021, then its reimbursement was effective in June 2023 Patients treated with pembrolizumab will be included prospectively on the start date of the study, i.e. on February 2024; patients treated since February 2021 via compassionate use of pembrolizumab will be included retrospectively A total of 600 patients are expected. The theoretical duration of inclusion is set at 2 years. All patients will be followed up for 3 years. | ArmGroups: [{'label': 'Retrospective group', 'description': 'Registration of patients treated with pembrolizumab since February 2021. Collection of tumour sample archives will be associated'}, {'label': 'Prospective group', 'description': 'Recruitment of metastatic colorectal cancer patients with microsatellite instability prior to the first administration of pembrolizumab immunotherapy. Blood and tumour sampling will be combined.'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Identification of predictive factors of resistance to pembrolizumab in first-line treatment of MSI and/or dMMR metastatic colorectal cancer', 'description': 'Primary resistance will be defined as immediate progression of the disease (at the time of the first assessment, excluding pseudoprogression) Secondary resistance will be defined as progression occurring after control of the disease.', 'timeFrame': '2 years'}] | SecondaryOutcomes: N/A |
Title: A Phase I Trial of a Live, Genetically Modified Salmonella Typhimurium (VNP20009) for the Treatment of Cancer by Intravenous Administration | Condition: Unspecified Adult Solid Tumor, Protocol Specific | Keywords: unspecified adult solid tumor, protocol specific | Summary: | Description: OBJECTIVES:
* Determine the maximum tolerated dose or minimum effective dose and associated toxic effects of VNP20009 in patients with advanced solid tumors.
* Determine whether VNP20009 can be detected in tumors after treatment in these patients.
* Determine the pharmacokinetics of this treatment regimen in these patients.
* Determine the antitumor effects of this treatment regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive VNP20009 IV over 4 hours on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable disease or partial or complete response (CR) may receive additional courses every 35 days for up to 12 total doses or 2 courses past a CR.
Cohorts of 3-6 patients receive escalating doses of VNP20009 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 6-9 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 14-45 patients will be accrued for this study. | ArmGroups: N/A | Interventions:[{'type': 'BIOLOGICAL', 'name': 'salmonella VNP20009'}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as "Chemotherapy") Versus Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer) | Condition: Gastric Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'ONO-4538 + ipilimumab + chemotherapy', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: ONO-4538', 'Drug: Ipilimumab', 'Drug: Oxaliplatin', 'Drug: Capecitabine', 'Drug: S-1']}, {'label': 'Chemotherapy', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: Capecitabine', 'Drug: S-1']}] | Interventions:[{'type': 'DRUG', 'name': 'ONO-4538', 'description': 'Specified dose on specified days', 'armGroupLabels': ['ONO-4538 + ipilimumab + chemotherapy'], 'otherNames': ['Nivolumab', 'Opdivo']}, {'type': 'DRUG', 'name': 'Ipilimumab', 'description': 'Specified dose on specified days', 'armGroupLabels': ['ONO-4538 + ipilimumab + chemotherapy'], 'otherNames': ['BMS-734016', 'Yervoy']}, {'type': 'DRUG', 'name': 'Oxaliplatin', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Chemotherapy', 'ONO-4538 + ipilimumab + chemotherapy']}, {'type': 'DRUG', 'name': 'Capecitabine', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Chemotherapy', 'ONO-4538 + ipilimumab + chemotherapy']}, {'type': 'DRUG', 'name': 'S-1', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Chemotherapy', 'ONO-4538 + ipilimumab + chemotherapy'], 'otherNames': ['Tegafur-gimeracil-oteracil potassium']}] | PrimaryOutcomes: [{'measure': 'Overall survival (OS)', 'timeFrame': 'up to 3 years'}] | SecondaryOutcomes: [{'measure': 'Progression-free survival (PFS) (site investigator assessment)', 'timeFrame': 'up to 3 years'}, {'measure': 'Objective response rate (ORR) (site investigator assessment)', 'timeFrame': 'up to 3 years'}, {'measure': 'Best overall response (BOR) (site investigator assessment)', 'timeFrame': 'up to 3 years'}, {'measure': 'Duration of response (DOR) (site investigator assessment)', 'timeFrame': 'up to 3 years'}, {'measure': 'Disease control rate (DCR) (site investigator assessment)', 'timeFrame': 'up to 3 years'}, {'measure': 'Time to response (TTR) (site investigator assessment)', 'timeFrame': 'up to 3 years'}, {'measure': 'Maximum percent change in the sum diameters of the target lesions (site investigator assessment)', 'timeFrame': 'up to 3 years'}, {'measure': 'Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)', 'timeFrame': 'up to 3 years'}, {'measure': 'Adverse event', 'timeFrame': 'Up to 30 days after the last dose'}] |
Title: A Phase II Combined Modality Protocol of Debulking Surgery With Heated Intraoperative Chemotherapy (HIPEC) Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancers | Condition: Recurrent Ovarian Cancer, Fallopian Tube Cancer | Keywords: Primary peritoneal | Summary: | Description: This is a phase II , open label, single center study of surgery followed by heated intraoperative cisplatin in patients with recurrent ovarian, primary peritoneal or fallopian tube cancers. Approximately twenty patients will receive surgery and intraoperative (hyperthermic) cisplatin followed by four consecutive courses of outpatient intraperitoneal cisplatin and doxorubicin given on days 1 and 8 during a 3 week cycle. | ArmGroups: [{'label': 'Out-Patient Intraperitoneal Chemotherapy', 'type': 'EXPERIMENTAL', 'description': 'Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 \\& 8 during a 3 week cycle.', 'interventionNames': ['Drug: Cisplatin', 'Drug: Doxorubicin']}] | Interventions:[{'type': 'DRUG', 'name': 'Cisplatin', 'description': 'Cisplatin (75 mg/m2) prepared in 2L normal saline.', 'armGroupLabels': ['Out-Patient Intraperitoneal Chemotherapy'], 'otherNames': ['cis-diamminedichloroplatinum(II) (CDDP)', 'Platinol', 'Platinol-AQ']}, {'type': 'DRUG', 'name': 'Doxorubicin', 'description': 'Doxorubicin (25 mg flat dose) prepared in 500 ml dialysis fluid (glucose or icodextrin-based).', 'armGroupLabels': ['Out-Patient Intraperitoneal Chemotherapy'], 'otherNames': ['hydroxyldaunorubicin', 'Adriamycin']}] | PrimaryOutcomes: [{'measure': 'Adverse Event Rate and/or Laboratory Changes', 'description': 'The adverse event rate and laboratory changes will be used to investigate the safety of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy.', 'timeFrame': '5 years'}, {'measure': 'Toxicity Rating Based on NCI Common Toxicity Criteria', 'description': 'Patients will be rated for toxicity prior to each cycle using the NCI Common Toxicity Criteria (NCICTC; see the CTCAE, Version 4.0).', 'timeFrame': 'Up to 5 years'}] | SecondaryOutcomes: [{'measure': 'Time to Serum Ca-125 Nadir and/or CT Response (RECIST Criteria)', 'description': 'Efficacy of surgical resection with HIPEC combined with repeated intraperitoneal chemotherapy: The end point will be the objective response rate and progression-free survival as well as the overall survival, if feasible. We will analyze the time to serum Ca 125 nadir and/or CT response based on Recist criteria.', 'timeFrame': 'Up to 5 years (survival)'}, {'measure': 'Kaplan-Meier Curves for Patient Overall Survival', 'description': 'Kaplan-Meier analysis will be done using PROC LIFETEST in Statistical Application Software (SAS).', 'timeFrame': 'Up to 5 years, survival'}] |
Title: Comparison of Safety and Clinical Benefit of Injections Subcutaneously Talazoparib Versus Oral Talazoparib in Patients With Advanced Solid Tumors ( Phase I ) | Condition: Advanced or Recurrent Solid Tumors, Breast Neoplasm | Keywords: Subcutaneously Talazoparib | Summary: | Description: The intent of this study was to assess the safety and efficacy of two forms of Talazoparib therapy for the treatment of advanced solid tumors . After an enrollment period, patients will randomized to receive oral Talazoparib (1 mg, one times a day ) or subcutaneously Talazoparib (1 mg by subcutaneous injection with NovoPen / Autopen) one times a day in the appropriate volume | ArmGroups: [{'label': 'Injections Subcutaneously Talazoparib', 'type': 'EXPERIMENTAL', 'description': 'Patients receive per day single dose of subcutaneous Injection contains 1 mg Talazoparib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nAuto-Injector delivers a single dose of 1 mg Talazoparib injection (subcutaneous)', 'interventionNames': ['Biological: Injections Subcutaneously Talazoparib']}, {'label': 'Oral capsules Talazoparib', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients receive 1 mg of Talazoparib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Oral capsules Talazoparib']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'Injections Subcutaneously Talazoparib', 'description': 'Patients receive per day single dose of subcutaneous Injection contains 1 mg Talazoparib on days 1-28', 'armGroupLabels': ['Injections Subcutaneously Talazoparib'], 'otherNames': ['MDV3800', 'BMN673']}, {'type': 'DRUG', 'name': 'Oral capsules Talazoparib', 'description': 'Patients receive 1 mg of Talazoparib PO QD on days 1-28.', 'armGroupLabels': ['Oral capsules Talazoparib'], 'otherNames': ['MDV3800', 'BMN673']}] | PrimaryOutcomes: [{'measure': 'Frequency of occurrence and evaluation of adverse events in the use of Subcutaneously Talazoparib ( 1 mg / dose )', 'description': 'Frequency of occurrence and evaluation of adverse events in the use of Subcutaneously Talazoparib , assessed by percentage of patients with any Adverse Event (AE), leading to Study Drug Discontinuation, Serious Adverse Event (SAE), related to study drug, SAE related to study drug.\n\nIncidence of toxicity, graded according to the National Cancer Institute (NCI) CTCAE version 4.03 Incidence of toxicity, graded according to the National Cancer Institute (NCI) CTCAE version 4.03', 'timeFrame': 'Anticipated in about 12 month following first patient enrolled'}] | SecondaryOutcomes: [{'measure': 'Clinical Benefit of Injections Subcutaneously Talazoparib', 'description': 'Clinical benefit (CB) defined as any of the following, complete response, partial response, or stable disease for \\> 24 weeks by RECIST 1.1. Assessments performed using computed tomography (CT) or magnetic resonance imaging (MRI) or ultrasound examination (Use) scan every 9 weeks.', 'timeFrame': 'Every 9 weeks for 12 months'}] |
Title: Pilot Study of Dynamic Contrast Enhanced Computed Tomography (DCE-CT) Imaging for the Assessment of Radiation Therapy Outcome for Liver Cancer Patients | Condition: Liver Cancer | Keywords: Radiation, Metastases, Dynamic Contrast Enhanced Computed Tomography, Pilot | Summary: | Description: Patients will undergo standard of care SBRT while also receiving DCE-CT, also known as perfusion CT, pre-treatment, 6 hours post-treatment and 6 weeks post-treatment. | ArmGroups: [{'label': 'Dynamic Contrast Enhanced Computed Tomography', 'type': 'EXPERIMENTAL', 'description': 'DCE-CT, also known as perfusion CT, is a functional imaging modality that uses repeated computed tomography imaging after injection of an iodine based contrast agent.', 'interventionNames': ['Diagnostic Test: Dynamic Contrast Enhanced Computed Tomography']}] | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'Dynamic Contrast Enhanced Computed Tomography', 'description': 'Patients will receive DCE-CT prior to the start of standard of care, Stereotactic Body Radiation Therapy (SBRT), as well as 6 hours post administration of SBRT and 6 weeks post administration of SBRT.', 'armGroupLabels': ['Dynamic Contrast Enhanced Computed Tomography'], 'otherNames': ['DCE-CT', 'Perfusion CT']}] | PrimaryOutcomes: [{'measure': 'DCE-CT Perfusion Metrics: K-Trans', 'description': 'Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through K-Trans (extraction-flow product) as shown through DCE-CT imaging.', 'timeFrame': 'Baseline to end of follow-up, up to 12 weeks'}, {'measure': 'DCE-CT Perfusion Metrics: Blood Volume', 'description': 'Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through blood volume as shown through DCE-CT imaging.', 'timeFrame': 'Baseline to end of follow-up, up to 12 weeks'}, {'measure': 'DCE-CT Perfusion Metrics: Blood Flow', 'description': 'Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through blood flow as shown through DCE-CT imaging.', 'timeFrame': 'Baseline to end of follow-up, up to 12 weeks'}] | SecondaryOutcomes: [{'measure': 'Correlation Between Patient Demographics and K-Trans: Age', 'description': 'Stratify K-Trans results by age to determine correlation of DCE-CT imaging results compared to patient demographics', 'timeFrame': 'Post follow-up to end of study, up to 12 months'}, {'measure': 'Correlation Between Patient Demographics and K-Trans: Sex', 'description': 'Stratify K-Trans results by sex to determine correlation of DCE-CT imaging results compared to patient demographics', 'timeFrame': 'Post follow-up to end of study, up to 12 months'}, {'measure': 'Correlation Between Patient Demographics and K-Trans: Race', 'description': 'Stratify K-Trans results by race to determine correlation of DCE-CT imaging results compared to patient demographics', 'timeFrame': 'Post follow-up to end of study, up to 12 months'}, {'measure': 'Correlation Between Patient Demographics and K-Trans: Clinical Stage of Disease', 'description': 'Stratify K-Trans results by clinical stage at diagnosis to determine correlation of DCE-CT imaging results compared to patient demographics', 'timeFrame': 'Post follow-up to end of study, up to 12 months'}, {'measure': 'Correlation Between Patient Demographics and Blood Volume: Age', 'description': 'Stratify blood volume results age to determine correlation of DCE-CT imaging results compared to patient demographics', 'timeFrame': 'Post follow-up to end of study, up to 12 months'}, {'measure': 'Correlation Between Patient Demographics and Blood Volume: Sex', 'description': 'Stratify blood volume results sex to determine correlation of DCE-CT imaging results compared to patient demographics', 'timeFrame': 'Post follow-up to end of study, up to 12 months'}, {'measure': 'Correlation Between Patient Demographics and Blood Volume: Race', 'description': 'Stratify blood volume results race to determine correlation of DCE-CT imaging results compared to patient demographics', 'timeFrame': 'Post follow-up to end of study, up to 12 months'}, {'measure': 'Correlation Between Patient Demographics and Blood Volume: Clinical Stage of Disease', 'description': 'Stratify blood volume results by clinical stage at diagnosis to determine correlation of DCE-CT imaging results compared to patient demographics', 'timeFrame': 'Post follow-up to end of study, up to 12 months'}, {'measure': 'Correlation Between Patient Demographics and Blood Flow: Age', 'description': 'Stratify blood flow results age to determine correlation of DCE-CT imaging results compared to patient demographics', 'timeFrame': 'Post follow-up to end of study, up to 12 months'}, {'measure': 'Correlation Between Patient Demographics and Blood Flow: Sex', 'description': 'Stratify blood flow results sex to determine correlation of DCE-CT imaging results compared to patient demographics', 'timeFrame': 'Post follow-up to end of study, up to 12 months'}, {'measure': 'Correlation Between Patient Demographics and Blood Flow: Race', 'description': 'Stratify blood flow results race to determine correlation of DCE-CT imaging results compared to patient demographics', 'timeFrame': 'Post follow-up to end of study, up to 12 months'}, {'measure': 'Correlation Between Patient Demographics and Blood Flow: Clinical Stage of Disease', 'description': 'Stratify blood flow results by clinical stage at diagnosis to determine correlation of DCE-CT imaging results compared to patient demographics', 'timeFrame': 'Post follow-up to end of study, up to 12 months'}] |
Title: Phase I/II Study of Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC) | Condition: Non-small Cell Lung Cancer (NSCLC), Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Carcinoma, Non Small Cell Lung Cancer, Non Small Cell Lung Carcinoma | Keywords: immune checkpoint inhibitor (CPI), pathologic complete response (pCR), aerosolized drug delivery, immunosuppressive tumor microenvironment (TME), reversible epigenetic mechanisms, DNA demethylating agents, nebulizer treatment, AZA | Summary: | Description: Background:
* Lung cancer is the leading cause of cancer-related mortality worldwide and accounted for nearly 160,000 deaths in 2023 in the US.
* Paradigm shifting results of immune checkpoint inhibitor (CPI) therapy in locally advanced, inoperable, and metastatic non-small cell lung cancer (NSCLC) have prompted clinical evaluation of these agents administered in the perioperative setting for patients with earlystage, operable disease.
* Pathologic complete responses (pCR) are observed in approximately 10% of early-stage NSCLC following CPI monotherapy and between 20-30% following platinum based chemotherapy and CPI treatment; as such most NSCLC are intrinsically resistant to immune checkpoint blockade.
* Many of the pathways that drive pulmonary carcinogenesis and render NSCLC resistant to immunotherapy are mediated by potentially reversible epigenetic mechanisms of which DNA methylation appears to be predominant.
* DNA demethylating agents such as azacytidine and decitabine can directly enhance the immunogenicity of lung cancer cells and ameliorate immunosuppression within the tumor microenvironment (TME).
* Poor bioavailability, as well as pharmacokinetic/pharmacodynamic limitations and systemic toxicities prevent optimal dosing of DNA demethylating agents for the treatment of solid tumors.
* One potential strategy to enhance the delivery of DNA demethylating agents to early-stage NSCLC while minimizing systemic toxicities is to administer these drugs by inhalation techniques.
* Preclinical studies have demonstrated that aerosolized AZA mediates epigenetic activation of tumor suppressor gene expression in orthotopic human NSCLC, and significantly prolongs the survival of mice bearing these xenografts without systemic toxicities.
* Conceivably, by simultaneously targeting lung cancer cells and their immunosuppressive TME, inhaled AZA may enhance the efficacy of chemo-immunotherapy for early-stage NSCLC.
Objectives:
* Phase I:
--To determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of neoadjuvant aerosolized AZA in participants with operable early-stage NSCLC treated with standard of care (SOC) platinum-based chemotherapy and Durvalumab.
* Phase II:
* To determine the frequency of pathologic complete responses (pCR) in participants receiving aerosolized AZA, durvalumab, and SOC platinum-based chemotherapy as induction therapy for early-stage NSCLC.
Eligibility Criteria:
* Stage IB-IIIA NSCLC irrespective of programmed death-ligand 1 (PD-L1) expression status.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* No prior therapy for NSCLC.
* Disease that can be safely accessed via bronchoscopic, thoracoscopic, or percutaneous biopsy, and participant willingness to undergo tumor biopsy before treatment (all participants) and bronchoscopic evaluation for PK analysis during treatment (Phase I only).
* Willing to undergo tumor resection per standard of care (SOC) guidelines following induction therapy.
* Age \>=18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of \<=1.
* Adequate organ and marrow function.
Design:
* Eligible participants will receive aerosolized AZA via AeroEclipse(R) II Breath Actuated nebulizer on three consecutive days (i.e., days 1, 2, 3) of a 21-day cycle for 3 cycles. Platinumdoublet chemotherapy using SOC guidelines and durvalumab will be administered on day 4 of each cycle.
* Anatomic resection \[lobectomy/segmentectomy/pneumonectomy with mediastinal lymph node dissection (MLND)\] will be performed within 3 weeks following completion of neoadjuvant therapy regimen.
* The dose of AZA will be escalated using a 3+3 design with no intra-patient dose escalation (45 - 75 mg/m2/inhalation) to maximize intra-tumoral DNA methyltransferase (DNMT) 1 depletion while avoiding dose-limiting pulmonary or systemic toxicities attributable to this agent during the three cycles of therapy.
* Once the RP2D of aerosolized AZA has been defined either by toxicity or feasibility, that cohort will be expanded to a total of 17 participants to determine pathologic complete response rates at the RP2D using a Simon optimal design for phase II trials.
* If 4 or more of 17 participants treated at the RP2D experience pCR, an additional 20 evaluable participants will be accrued (2nd stage).
* Pharmacokinetic (PK) / pharmacodynamic (PD) effects as well as DNMT, CTA, and immune-related gene expression levels in tumor tissues may be evaluated.
* Additional studies will be performed to examine if the treatment regimen alters DNA methylation and cytokine levels and modulates the phenotypes of immune cells in pulmonary lavage fluids.
* Accrual ceiling: 60 participants. | ArmGroups: [{'label': '1/ Phase I Dose Escalation', 'type': 'EXPERIMENTAL', 'description': 'Histology specific SOC platinum-based chemotherapy with durvalumab plus escalating/de-escalating doses of aerosolized azacytidine', 'interventionNames': ['Drug: azacytidine', 'Drug: carboplatin', 'Drug: paclitaxel', 'Drug: durvalumab', 'Drug: cisplatin', 'Drug: gemcitabine', 'Drug: pemetrexed']}, {'label': '2/ Phase II Dose Expansion', 'type': 'EXPERIMENTAL', 'description': 'Histology specific SOC platinum-based chemotherapy with durvalumab plus RP2D of aerosolized azacytidine', 'interventionNames': ['Drug: azacytidine', 'Drug: carboplatin', 'Drug: paclitaxel', 'Drug: durvalumab', 'Drug: cisplatin', 'Drug: gemcitabine', 'Drug: pemetrexed']}] | Interventions:[{'type': 'DRUG', 'name': 'azacytidine', 'description': 'Aerosolized azacytidine (AZA) via nebulizer on 3 consecutive days during the first week of every cycle (1 cycle=21 days), for a maximum (total) of 3 cycles.\n\nAzacytidine will be given at escalating doses in phase 1, and at the established RP2D in phase 2.', 'armGroupLabels': ['1/ Phase I Dose Escalation', '2/ Phase II Dose Expansion']}, {'type': 'DRUG', 'name': 'carboplatin', 'description': 'Carboplatin (intravenous/IV), area under the serum drug concentration-time curve (AUC)=5-6 mg/mL/min based on cancer histology administered on day 4 of every cycle (1 cycle=21 days), for a maximum (total) of 3 cycles.', 'armGroupLabels': ['1/ Phase I Dose Escalation', '2/ Phase II Dose Expansion']}, {'type': 'DRUG', 'name': 'paclitaxel', 'description': 'Paclitaxel (IV), 200 mg/m\\^2, is administered on day 4 of every cycle (1 cycle=21 days), for a maximum (total) of 3 cycles.', 'armGroupLabels': ['1/ Phase I Dose Escalation', '2/ Phase II Dose Expansion']}, {'type': 'DRUG', 'name': 'durvalumab', 'description': 'Durvalumab (IV) administered as a flat dose of 1500 mg on day 4 of every cycle (1 cycle=21 days), for a maximum (total) of 3 cycles.', 'armGroupLabels': ['1/ Phase I Dose Escalation', '2/ Phase II Dose Expansion']}, {'type': 'DRUG', 'name': 'cisplatin', 'description': 'Cisplatin (IV), 75 mg/m\\^2, administered on day 4 of every cycle (1 cycle=21 days), for a maximum (total) of 3 cycles.', 'armGroupLabels': ['1/ Phase I Dose Escalation', '2/ Phase II Dose Expansion']}, {'type': 'DRUG', 'name': 'gemcitabine', 'description': 'Gemcitabine (IV), 1,250 mg/m\\^2, administered on day 4 of every cycle (1 cycle=21 days), for a maximum (total) of 3 cycles.', 'armGroupLabels': ['1/ Phase I Dose Escalation', '2/ Phase II Dose Expansion']}, {'type': 'DRUG', 'name': 'pemetrexed', 'description': 'Pemetrexed (IV), 500 mg/m\\^2, administered on day 4 of every cycle (1 cycle=21 days), for a maximum (total) of 3 cycles.', 'armGroupLabels': ['1/ Phase I Dose Escalation', '2/ Phase II Dose Expansion']}] | PrimaryOutcomes: [{'measure': 'Phase I: To determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of neoadjuvant aerosolized AZA in participants with operable early-stage NSCLC treated with standard of care (SOC) platinum-based chemotherapy and du...', 'description': 'DLTs noted at each dose level will be reported.', 'timeFrame': 'starts at initiation of study drug, though end of DLT period'}, {'measure': 'Phase II: To determine the frequency of pathologic complete responses (pCR) in participants receiving aerosolized AZA, durvalumab, and SOC platinum-based chemotherapy as induction therapy for early-stage NSCLC', 'description': 'Pathologic complete responses (pCR) is defined as no viable cancer cells in samples collected on histopathologic assessment. Fraction of evaluable participants who experience a pCR will be determined and reported along with 80% and 95% two-sided confidence intervals.', 'timeFrame': 'baseline (pre-treatment biopsy), and at the time of SOC surgery post-cycle 3'}] | SecondaryOutcomes: [{'measure': 'To evaluate pharmacokinetics', 'description': 'Pharmacokinetic endpoints will be reported using descriptive statistics.', 'timeFrame': 'All participants: Cycle 1, Day 1 or 2, and Cycle 3, Day 1 or 2. Participants with MTD treatment: Cycle 1, Day 1 or 2, and Cycle 2, Day 1 or 2, and Cycle 3, Day 1 or 2.'}, {'measure': 'To evaluate safety of the combination of AZA and chemo-durvalumab in participants with operable early-stage NSCLC', 'description': 'Safety of the agents will be assessed by determining the grade of adverse events noted in each participant and reporting the fraction with Grade 3 and Grade 4 adverse events. Safety data will be presented in a summary. The safety data will consist of the reporting of all adverse events, and may also include reporting vital signs, physical examination data, and laboratory safety data.', 'timeFrame': 'starts at initiation of study drug, through 64 days after the last study drug administration'}, {'measure': 'To evaluate event-free survival (EFS)', 'description': 'Event-free survival (EFS) at three years post treatment will be determined as the duration of time from start of treatment to time of disease recurrence or appearance of new primary cancer, whichever occurs first as appropriate using the Kaplan-Meier method and reported along with a 95% confidence interval, separately for phase I and II. The median EFS will also be reported along with a 95% confidence interval.', 'timeFrame': 'baseline, Day 64 (treatment evaluation), then post-surgical 1 month, 3 months, and every 3 months thereafter until disease progression, until up to 3 years from the treatment initiation'}, {'measure': 'To evaluate objective response (complete response [CR] + partial response [PR]) and stable disease [SD] per RECIST 1.1', 'description': 'The objective response rate will be based on CR+PR and the disease stabilization rate (SD) and reported separately in phase I and II along with a 95% confidence interval for each.', 'timeFrame': 'baseline, and at Day 64 (treatment evaluation)'}, {'measure': 'To evaluate major pathologic response (MPR) rate', 'description': 'MPR rate is defined as \\<10% viable cancer cells in samples collected per histopathologic assessment. The objective response rate based on the MPR rate will be reported separately in phase I and II along with a 95% confidence interval for each.', 'timeFrame': 'baseline (pre-treatment biopsy), and at the time of SOC surgery post-cycle 3'}] |
Title: PET Interest in the Follow Up of Colorectal Cancer Stage II and III: Phase III Randomised Study | Condition: Colorectal Cancer | Keywords: colorectal cancer stage II and III | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'PROCEDURE', 'name': 'PET'}] | PrimaryOutcomes: [{'measure': 'Time to colorectal cancer relapse'}] | SecondaryOutcomes: [{'measure': 'Evaluation of overall survival in the two groups', 'timeFrame': 'after curative resection of colorectal cancer stage II or III'}, {'measure': 'Evaluation of the rate of curative surgery', 'timeFrame': 'after relapse'}, {'measure': 'Comparison of the medical cost in the two detection strategies'}] |
Title: ZD-1839 (Iressa®) With Concurrent Docetaxel and Conformal Three Dimensional Thoracic Radiation Followed by Consolidative Docetaxel and ZD-1839 for Patients With Stage III Non Small Cell Lung Cancer: A Phase I Study | Condition: Lung Cancer | Keywords: stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer, adenocarcinoma of the lung | Summary: | Description: OBJECTIVES:
* Determine the maximum tolerated dose of docetaxel that can be safely delivered in combination with gefitinib and a definitive course of 3-D planned thoracic radiotherapy in patients with stage III non-small cell lung cancer.
OUTLINE: This is a dose-escalation study of docetaxel.
* Chemoradiotherapy: Patients receive concurrent chemoradiotherapy comprising docetaxel IV over 30 minutes on day 1 and thoracic radiotherapy once daily on days 1-5 in weeks 1-7 in the absence of disease progression or unacceptable toxicity.
* Consolidation chemotherapy: Beginning 2 weeks after the completion of chemoradiotherapy, patients receive consolidation chemotherapy comprising docetaxel IV over 60 minutes on days 1 and 22.
* Gefitinib therapy: Patients also receive oral gefitinib once daily beginning at the start of chemoradiotherapy and continuing for up to 1 year\* in the absence of disease progression.
NOTE: \*Patients continue to receive gefitinib during the 2-week rest period between chemoradiotherapy and consolidation chemotherapy.
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Tumor tissue is tested to determine correlation between epidermal growth factor receptor presence and response to treatment.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 45 patients will be accrued in this study. | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'docetaxel'}, {'type': 'DRUG', 'name': 'gefitinib'}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis'}, {'type': 'RADIATION', 'name': 'radiation therapy'}] | PrimaryOutcomes: [{'measure': 'To determine the feasability of daily ZD1839 delivered with concurrent 3-dimensional planned thoracic radiation', 'timeFrame': 'baseline to 2 months'}] | SecondaryOutcomes: N/A |
Title: Screening More Patients for CRC Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings (SMARTER CRC) | Condition: Colorectal Carcinoma | Keywords: | Summary: | Description: PRIMARY OBJECTIVE:
I. Adapt, pilot, then test the implementation and scale-up of targeted direct mail and patient navigation programs.
OUTLINE:
This is an implementation-effectiveness trial of direct mail outreach and patient navigation intervention to improve rates of CRC screening. Eligible patients will be mailed a fecal immunochemical test (FIT). The mailed FIT and patient navigation interventions are a part of standard care and are carried out by the Medicaid health plan or clinic. Outcomes are tracked using reports from direct mail vendors, claims data from participating Medicaid health plans, clinic data from the electronic health record, chart review, and data from a REDCap database. The hypotheses will be tested using a two-arm cluster randomized trial design. Participating clinics will be randomized into two groups: Intervention and Usual Care. Medicaid health plans/ Coordinated care organizations (CCO) and clinic leadership participate in interviews and complete surveys.
The primary effectiveness outcome of this study is CRC screening likelihood in eligible Medicaid patients in intervention and control clinics at 6 months. Data will be collected at 6 time points: baseline, 6-months, 12-months, 18-months, 24-months, and 36-months.
Implementation outcomes and adaptations will be evaluated through interviews with clinic staff, patients, and CCO partners. Clinic staff in various roles related to the program (e.g., outreach workers, patient navigators, quality improvement leads) complete surveys and participate in interviews and observations at baseline, 6-9 months (post-implementation) and at approximately 12 months later, to assess clinic/health system level factors that may influence outcomes. Patients participate in interviews to explore patient experiences with the program. Regional and Organizational partners: CCO leaders, endoscopy providers (e.g., gastrointestinal specialists, general surgeons, primary care clinicians), and community organizations also participate in interviews. | ArmGroups: [{'label': 'SMARTER CRC Intervention Year 1', 'type': 'ACTIVE_COMPARATOR', 'description': 'In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected.', 'interventionNames': ['Other: Fecal Immunochemical Test', 'Other: Interview', 'Behavioral: Patient Navigation']}, {'label': 'SMARTER CRC Intervention Year 2', 'type': 'ACTIVE_COMPARATOR', 'description': 'In year 2, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected.', 'interventionNames': ['Other: Fecal Immunochemical Test', 'Other: Interview', 'Behavioral: Patient Navigation']}] | Interventions:[{'type': 'OTHER', 'name': 'Fecal Immunochemical Test', 'description': 'Patients due for CRC screening are mailed a FIT test by the clinic or health plan', 'armGroupLabels': ['SMARTER CRC Intervention Year 1', 'SMARTER CRC Intervention Year 2'], 'otherNames': ['FIT', 'iFOBT', 'immunoassay fecal occult blood test', 'immunochemical fecal occult blood test', 'Immunochemical FOBT', 'immunologic fecal occult blood test']}, {'type': 'OTHER', 'name': 'Interview', 'description': 'Participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations', 'armGroupLabels': ['SMARTER CRC Intervention Year 1', 'SMARTER CRC Intervention Year 2']}, {'type': 'BEHAVIORAL', 'name': 'Patient Navigation', 'description': 'Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators', 'armGroupLabels': ['SMARTER CRC Intervention Year 1', 'SMARTER CRC Intervention Year 2'], 'otherNames': ['Patient Navigator Program']}] | PrimaryOutcomes: [{'measure': 'Likelihood of any colorectal cancer (CRC) screening (for study-eligible patients)', 'description': 'Will use claims and vendor data to determine whether or not the patient completed CRC screening (i.e., fecal testing, FIT-DNA, sigmoidoscopy, CT colonography, or colonoscopy). To assess effectiveness of CRC screening completion, will use the generalized form of hierarchical linear model (binomial distribution with logit link) to account for clustering of patients within clinics and the assignment to arm at the clinic level.', 'timeFrame': 'Primary outcome at 6 months following CCO eligible patient list pull date'}] | SecondaryOutcomes: [{'measure': 'Completion of testing types (fecal testing, FIT-DNA, CT Colonography, Colonoscopy, Flex Sigmoidoscopy) and % completion', 'description': 'Will use claims and vendor data for calculating whether or not the patient completed each different type of screening.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Rate of CRC screening among the study-eligible population (by clinic)', 'description': 'Will use claims and vendor data for calculating CRC screening rates in clinics. For each clinic, N completed CRC screening / N eligible', 'timeFrame': '6 months'}, {'measure': 'Time to screening from study-eligible patient list pull', 'description': 'Days from study-eligible patient list pull to return of FIT or completion of other screening modality (colonoscopy, flex, FIT-DNA). Number of days at individual level.', 'timeFrame': 'Up to 12 months'}, {'measure': 'FIT Results', 'description': 'Results of the completed FITs', 'timeFrame': '6 months'}, {'measure': 'Patient Navigation Trainings (Intervention group)', 'description': 'Clinic participation (i.e., attendance count and staff roles) in patient navigation training.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Patient Navigation completed (Intervention group)', 'description': 'Patient navigation implemented = one or more live phone contact with the patient (binary at the individual level).', 'timeFrame': 'Up to 12 months'}, {'measure': 'Follow-up colonoscopy completion', 'description': 'The percentage of patients with abnormal FIT who completed follow-up colonoscopy.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Time to colonoscopy from abnormal FIT result', 'description': 'Days from abnormal FIT result to completion of follow-up colonoscopy. Number of days at the individual level.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Adenomas or cancers detected', 'description': 'Whether or not eligible patient had an adenoma or cancer detected. Binary at individual level.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Adaptations to core program components made by payer or clinic', 'description': 'Key informant interviews and practice facilitator field notes based on the FRAME framework for tracking adaptations will be used to identify and qualitatively assess adaptations.', 'timeFrame': 'Up to 36 months'}, {'measure': 'Key Implementation Factors', 'description': 'Qualitative key informant interviews with patient, clinic, and payer stakeholders to identify implementation strategies and factors relevant to rural context. Guided by Consolidated Framework for Implementation Research (CFIR) and the Expert Recommendations for Implementing Change (ERIC) classification.', 'timeFrame': 'Up to 36 months'}, {'measure': 'Colonoscopy referral', 'description': 'For each clinic, the percent of patients who receive a referral to colonoscopy. Proportion at the clinic level.', 'timeFrame': 'Up to 12 months'}] |
Title: Phase II Study to Evaluate the Efficacy and Safety of Sirolimus in Subjects With Metastatic, Mismatch Repair Deficient Solid Tumors After Immunotherapy | Condition: Metastatic dMMR Solid Cancer, Solid Tumor, Cancer, Metastatic Solid Tumor | Keywords: | Summary: | Description: Despite recent therapeutic strategies, including immunotherapy, treatment alternatives for patients with metastatic mismatch-repair deficient (dMMR) solid tumors remain scarce. Pre-clinical data suggests that dMMR tumors are susceptible to rapamycin (sirolimus), an mTOR inhibitor. In these tumors, characterized by higher levels of oxidative stress, sirolimus can exert a cytotoxic effect, led by the failure to repair DNA damage by inhibition of antioxidant enzymes such as FOXO3a triggered by Akt hyperactivation.
This proposal presents a phase 2 clinical trial designed to evaluate the efficacy of sirolimus in patients with dMMR solid tumors after immunotherapy. The investigators hypothesize that sirolimus will increase the overall response rate (ORR) by 20%. | ArmGroups: [{'label': 'Sirolimus', 'type': 'EXPERIMENTAL', 'description': 'Participants will be instructed to take 2 milligrams (mg) every day for 28 days (1 cycle). They will be evaluated in the oncology clinic every 2 weeks to make sure they are tolerating the medication well.', 'interventionNames': ['Drug: Sirolimus 2mg Tablet']}] | Interventions:[{'type': 'DRUG', 'name': 'Sirolimus 2mg Tablet', 'description': 'Sirolimus (oral) will be started at 2 mg daily. Sirolimus dosing will be titrated to meet serum trough levels of \\>8 ng/ml, assayed at 7 days after starting a new dose, by chromatography/mass spectrometry. Once adequate serum levels are met (≥8 ng/ml), the same dosing will be continued until progression of disease as evidenced by imaging, or unacceptable toxicity.', 'armGroupLabels': ['Sirolimus']}] | PrimaryOutcomes: [{'measure': 'Objective Response Rate (ORR)', 'description': 'To evaluate the efficacy of sirolimus in patients with metastatic mismatch repair deficient (dMMR) solid cancer after immunotherapy (either due to disease progression or to inability to tolerate treatment), ORR will be determined. For this study ORR will be defined as the percentage of patients who achieve either a complete response (CR = disappearance of all target tumors); or a partial response (PR = ≥30% decrease in the sum of the longest diameters of target tumors) based on Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1) following review of imaging (CT-CAP or PET-CT) data.', 'timeFrame': 'Up to approximately 24 weeks after achieving therapeutic sirolimus levels, up to 7 months total'}] | SecondaryOutcomes: [{'measure': 'Progression Free Survival (PFS)', 'description': 'PFS, the duration of time from treatment initiation to progression of known metastases or new metastatic site, or death from any cause after a timeframe of 24 weeks, will be determined following treatment with sirolimus in patients with metastatic mismatch repair deficient (dMMR) solid cancer after immunotherapy (either due to disease progression or to inability to tolerate treatment). Group median number of months will be reported.', 'timeFrame': 'Approximately 24 weeks after sirolimus initiation, up to approximately 7 months total'}, {'measure': 'Response Duration (RD)', 'description': 'RD, defined as the duration of time from documentation of tumor response until the time of disease progression will be determined following treatment with sirolimus in patients with metastatic mismatch repair deficient (dMMR) solid cancer after immunotherapy (either due to disease progression or to inability to tolerate treatment). Group median number of months will be reported.', 'timeFrame': 'Up to ~24 weeks from the time of tumor response, up to 7 months total'}, {'measure': 'Overall Survival (OS)', 'description': 'Overall Survival, the duration of time from the start of treatment initiation for patients diagnosed with metastatic mismatch repair deficient (dMMR) solid cancer after immunotherapy (either due to disease progression or inability to tolerate treatment) to death from any cause, will be determined. Group median number of months will be reported.', 'timeFrame': 'Approximately 24 weeks after sirolimus initiation, up to approximately 7 months total'}] |
Title: Descriptive Observational Epidemiological Study on the Characteristics of Thyroid Cancer in Patients Treated in Oncology Services of Spanish Centers: National Registry of Thyroid Cancer - Differentiated, Medullary and Anaplastic | Condition: Thyroid Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: N/A | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Hystopathological characteristics of the tumor', 'description': 'Based on pathologist evaluation of biopsy including differentiated, medullar or anaplasic.', 'timeFrame': 'Baseline'}, {'measure': 'Situation of the tumor at first-diagnosis', 'description': 'Local tumor, locoregional tumor or metastatic disease.', 'timeFrame': 'Baseline'}, {'measure': 'Tumor-Node-Metastasis classification', 'description': 'Based on the AJCC (American Joint Committee on Cancer) 2018 TNM system: T for extent or size of the tumor, N for lymph nodes spread and M for metastasis.', 'timeFrame': 'Baseline'}, {'measure': 'Tumor Stage', 'description': 'From I to IV, based on the interpretation of the TNM classification and depending on the hystopathological characteristics of the tumor.', 'timeFrame': 'Baseline'}] | SecondaryOutcomes: [{'measure': 'Patient situation at the end of treatment', 'description': 'Results of clinical evaluation of the disease including complete response, partial response, stable disease, progression of disease or death', 'timeFrame': '12 months'}, {'measure': 'Number of patients with BRAF mutation', 'description': 'Total patients with available results on BRAF status and proportion of patients with mutated BRAF or native BRAF.', 'timeFrame': '12 months'}, {'measure': 'Number of patients with RET mutation', 'description': 'Total patients with available results on RET status and proportion of patients with mutated RET or native RET.', 'timeFrame': '12 months'}, {'measure': 'Number of patients with PI3K mutation', 'description': 'Total patients with available results on PI3K status and proportion of patients with mutated PI3K or native PI3K.', 'timeFrame': '12 months'}, {'measure': 'Number of patients with RAS mutation', 'description': 'Total patients with available results on RAS status and proportion of patients with mutated RAS or native RAS.', 'timeFrame': '12 months'}, {'measure': 'Number of patients with PAX8/PAR mutation', 'description': 'Total patients with available results on PAX8/PAR status and proportion of patients with mutated PAX8/PAR or native PAX8/PAR.', 'timeFrame': '12 months'}, {'measure': 'Number of patients with P53 mutation', 'description': 'Total patients with available results on P53 status and proportion of patients with mutated P53 or native P53.', 'timeFrame': '12 months'}, {'measure': 'Number of patients with PTEN mutation', 'description': 'Total patients with available results on PTEN status and proportion of patients with mutated PTEN or native PTEN.', 'timeFrame': '12 months'}] |
Title: An Open-label Study of Xeloda Plus Taxotere on Treatment Response in Patients With HER2-neu-negative, and the Addition of Herceptin for HER2-neu-positive Breast Cancer | Condition: Breast Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'HER2-NEU Positive', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: capecitabine [Xeloda]', 'Drug: Taxotere', 'Drug: Herceptin (HER2-neu positive patients only)']}, {'label': 'HER2-NEU Negative', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: capecitabine [Xeloda]', 'Drug: Taxotere']}] | Interventions:[{'type': 'DRUG', 'name': 'capecitabine [Xeloda]', 'description': '825mg/m2 po bid on days 1-14 of each 3 week cycle', 'armGroupLabels': ['HER2-NEU Positive']}, {'type': 'DRUG', 'name': 'Taxotere', 'description': '75mg/m2 iv on day 1 of each 3 week cycle', 'armGroupLabels': ['HER2-NEU Positive']}, {'type': 'DRUG', 'name': 'Herceptin (HER2-neu positive patients only)', 'description': '4mg/kg iv (loading dose) followed by 2mg/kg iv weekly', 'armGroupLabels': ['HER2-NEU Positive']}, {'type': 'DRUG', 'name': 'capecitabine [Xeloda]', 'description': '825mg/m2 po bid on days 1-14 of each 3 week cycle', 'armGroupLabels': ['HER2-NEU Negative']}, {'type': 'DRUG', 'name': 'Taxotere', 'description': '75mg/m2 iv on day 1 of each 3 week cycle', 'armGroupLabels': ['HER2-NEU Negative']}] | PrimaryOutcomes: [{'measure': 'Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery', 'description': 'Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.', 'timeFrame': 'at the time of definitive surgery; after four 3-week cycles (3-4 months)'}] | SecondaryOutcomes: [{'measure': 'Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery', 'description': 'Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment.', 'timeFrame': 'at the time of definitive surgery; after four 3-week cycles (3-4 months)'}, {'measure': 'Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))', 'description': 'The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders.', 'timeFrame': 'post 2 and 4, 3-week cycles of treatment'}, {'measure': 'Percentage of Participants With Local Recurrence', 'description': 'Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment.', 'timeFrame': '30 - 1102 days'}, {'measure': 'Participants With Disease-Free Survival', 'description': 'Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free.', 'timeFrame': '30 - 1102 days'}, {'measure': 'Participants With Overall Survival', 'description': 'Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment.', 'timeFrame': '22 - 1191 days'}] |
Title: Effectiveness of Self-monitoring Physical Activity With a Smartphone Application and Physiotherapy Coaching in Cancer Patients: a Randomized Controlled Trial (SMART-COACH Trial) | Condition: Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'RunKeeper app + physiotherapy coaching', 'type': 'EXPERIMENTAL', 'description': "Group A will use the RunKeeper app for half a year to self-monitor leisure-time PA. Besides, patients are requested to activate the 'training reminder' option in the RunKeeper app, which is all explained in a brief user's manual. In addition, patients will be educated about the health risks of a sedentary lifestyle, inactivity and (when applicable) other unhealthy lifestyle behaviors (e.g. unhealthy diet, overweight or obesity, sun exposure, alcohol intake). Benefits of a behavior change, becoming physically active and pursuing a healthy lifestyle will be explained by a trained physiotherapist who will also coach the patient during the PA program.", 'interventionNames': ['Other: RunKeeper app + physiotherapy coaching']}, {'label': 'usual care', 'type': 'OTHER', 'description': 'In the UMCG, patients who receive cancer treatment or in surveillance after treatment are normally advised to live healthy, stay active, and to maintain their weight.', 'interventionNames': ['Other: Usual care']}] | Interventions:[{'type': 'OTHER', 'name': 'RunKeeper app + physiotherapy coaching', 'description': 'RunKeeper app for half a year to self-monitor leisure-time PA.', 'armGroupLabels': ['RunKeeper app + physiotherapy coaching']}, {'type': 'OTHER', 'name': 'Usual care', 'description': 'In the UMCG, patients who receive cancer treatment or in surveillance after treatment are normally advised to live healthy, stay active, and to maintain their weight.', 'armGroupLabels': ['usual care']}] | PrimaryOutcomes: [{'measure': 'examine the effectiveness of the RunKeeper use with additional physiotherapy coaching', 'description': "To examine the effectiveness of the RunKeeper use with additional physiotherapy coaching in improving patients' leisure-time PA compared with usual care in cancer patients as measured by the PASE subscale leisure-time Sum Score at baseline, 6, 12 and 26 weeks.", 'timeFrame': '6 months'}] | SecondaryOutcomes: [{'measure': 'investigate the improvement in the percentage of patients meeting the prescribed total weekly minutes of leisure-time PA', 'description': 'To investigate the improvement in the percentage of patients meeting the prescribed total weekly minutes of leisure-time PA with moderate to vigorous intensity corresponding to the NNGB as measured by accelerometry (ActiGraph GT3X-BT) at baseline, 12 and 26 weeks.', 'timeFrame': '6 months'}, {'measure': "investigate the improvement in patients' weekly total minutes of leisure-time PA and sedentary time", 'description': "To investigate the improvement in patients' weekly total minutes of leisure-time PA and sedentary time as measured by the PASE subscales leisure-time Total Minutes of PA and Sedentary Time at baseline, 6, 12 and 26 weeks.", 'timeFrame': '6 months'}, {'measure': "examine the improvement in patients' health-related quality of life (HR-QoL)", 'description': "To examine the improvement in patients' health-related quality of life (HR-QoL) as measured by the European Organization for Treatment of Cancer QoL (EORTC QLQ-C30) questionnaire at baseline, 12 and 26 weeks.", 'timeFrame': '6 months'}, {'measure': "examine the improvement in patients' self-efficacy", 'description': "To examine the improvement in patients' self-efficacy as measured by the Algemene Competentie Schaal (ALCOS) questionnaire at baseline, 12 and 26 weeks.", 'timeFrame': '6 months'}, {'measure': "explore patients' PA Stage of Change", 'description': "To explore patients' PA Stage of Change as measured by the Physician-based Assessment and Counseling for Exercise (PACE) questionnaire at baseline, 12 and 26 weeks.", 'timeFrame': '6 months'}] |
Title: A Prospective Study on the Efficacy, Safety and Immune Effects of Dose-painting Radiation for Locally Advanced Non-small Cell Lung Cancer(LA-NSCLC) | Condition: Non-small Cell Lung Cancer Stage III, Non-small Cell Lung Cancer Stage II | Keywords: radiotherapy, dose-painting radiation, non-small cell lung cancer | Summary: | Description: The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer.
The primary endpoint is PFS. Secondary points contains ORR, OS, HRQoL, and safety. | ArmGroups: [{'label': 'Assigned Interventions', 'type': 'EXPERIMENTAL', 'description': "Radiation therapy: Dose-painting radiation\n\nSystemic treatment: Choose a systemic treatment plan according to the patient's genetic testing status\n\n(1) Chemotherapy\n\n1. Squamous cell carcinoma: Paclitaxel 135mg/m2 D1 + Cisplatin 25mg/m2 D1-3, every 21 days, a total of 2-4 cycles.\n2. Non-squamous cell carcinoma (adenocarcinoma, large cell carcinoma): Pemetrexed 500mg/m2 d1 + Cisplatin 75 mg/m2 d1-3, a total of 2-4 cycles.\n\n(2) Targeted therapy: According to the patient's genetic testing status, molecular targeted therapy such as EGFR-TKI and ALK inhibitors can be selected; (3) Immunotherapy: According to the patient's genetic testing status, immunotherapy such as PD1/PD-L1 inhibitors can be selected;", 'interventionNames': ['Radiation: Dose-Painting Radiation']}] | Interventions:[{'type': 'RADIATION', 'name': 'Dose-Painting Radiation', 'description': 'Radiation therapy:\n\n1. Delineation of target area:\n\n The primary tumor is delineated into different target areas according to the anatomical position of the tumor, including the central area tumor GTV-Tcentral and GTV-Tperipheral.\n2. Exposure dose:\n\n1) GTV-Tcentral: 2.0～2.5Gy/f, bid, 10-13d, physical dose 40-65Gy 2) GTV-Tperipheral: 3.0～4.0Gy/f, bid, 10-13d, physical dose 60-104Gy 3) GTV-N (mediastinal lymph node): 2.0Gy/f, bid, 10-13d, physical dose 40-52Gy', 'armGroupLabels': ['Assigned Interventions']}] | PrimaryOutcomes: [{'measure': 'FPS', 'description': 'progression-free survival (PFS) refers to the time from enrollment to the first recording of disease progression as determined by RECISTv1.1, or to death due to any cause (whichever occurs first). PFS will be analyzed in the ITT analysis set.', 'timeFrame': 'up to 3 years'}] | SecondaryOutcomes: [{'measure': 'ORR', 'description': 'Objective response rate, according to RECISTv1.1, the proportion of patients with CR or PR was determined. If the patient has not undergone a post-baseline assessment, it is considered unremission', 'timeFrame': 'up to 3 years'}, {'measure': 'OS', 'description': 'OS(Overall survival) refers to the time from enrollment to the first recorded death due to any cause (whichever occurs first).', 'timeFrame': 'up to 3 years'}, {'measure': 'HRQoL', 'description': 'HRQoL uses EORTCQLQ-C30 to assess the overall health of patients. The post-baseline score of the treatment group was studied, and the score changes from the baseline were summarized descriptively.', 'timeFrame': 'up to 3 years'}] |
Title: An Open-Label, Non-Randomized, Multicenter, Three-Stage, Phase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV) | Condition: Advanced Non-Small Cell Lung Cancer | Keywords: | Summary: | Description: Advanced non-small cell lung cancer is relatively unresponsive to chemotherapy. This is true for the nucleoside analogue gemcitabine, with a response rate of approximately 10%, as well as for 5-fluorouracil (5-FU). Even when gemcitabine is combined with other chemotherapeutic drugs or biological agents, the overall tumor response rate remains basically unchanged. S-1 is a new generation oral fluoropyrimidine that combines Tegafur (5-fluoro-1-(tetrahydro-2-furanyl)-2,4(1H,3H)-pyrimidinedione \[FT\]), an oral prodrug of 5-FU, with two modulators, Gimeracil (5-chloro-2,4-dihydroxypyridine \[CDHP\]), which inhibits 5-FU degradation by dihydropyrimidine dehydrogenase (DPD) inhibition, and Oteracil potassium (Oxo), which inhibits 5-FU phosphorylation in the digestive tract. This combination of 3 compounds is designed to achieve enhanced antitumor activity while decreasing gastrointestinal toxicity.
This is an open-label, multicenter, single-arm, 3-stage, Phase 2 study evaluating the efficacy and safety of S-1 in combination with cisplatin as 1st line therapy for patients with advanced NSCLC. The 3 stages of this study correspond to a run-in tolerability stage (stage 1), futility stage (stage 2), and decision stage (stage 3). The run-in tolerability stage will be conducted to assess any additional toxicity associated with a more frequent schedule of administration of cisplatin (75 mg/m2 every 3 weeks) compared with the dosing regimen established in a prior Phase I study in patients with advanced gastric cancer (75 mg/m2 every 4 weeks). The futility stage (stage 2) will be conducted to ensure that this treatment combination is sufficiently efficacious to expose a sufficient number of patients to be able to make a decision (stage 3) on whether this combination treatment warrants further evaluation in future studies. | ArmGroups: [{'label': '1', 'type': 'EXPERIMENTAL', 'description': 'All patients will receive S-1 orally at a dose of 25 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. Patient will also receive cisplatin, 75 mg/m2 as a 1- to 3-hour infusion on Day 1 of each cycle.', 'interventionNames': ['Drug: S-1']}] | Interventions:[{'type': 'DRUG', 'name': 'S-1', 'description': 'All patients will receive S-1 orally at a dose of 25 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The study may go to the third stage only if 7/31 (23%) or more patients have achieved a confirmed response (CR or PR) in stages 1 and 2 combined.', 'armGroupLabels': ['1']}] | PrimaryOutcomes: [{'measure': 'Overall tumor response rate (ORR - the proportion of patients with objective evidence of PR or CR)', 'timeFrame': 'Each cycle will last 21 days (14 days treatment, 7 days recovery) for a max of 6 cycles. Tumor assessments will be obtained at baseline and at the end of every even cycle.'}] | SecondaryOutcomes: [{'measure': 'To evaluate the safety profile of S-1', 'timeFrame': 'AEs will be reported through follow-up (30 days after the last dose of study medication); blood/urine will be collected at baseline ; Days 8 and 15; w/in 24 hrs prior to study drug on Day 1 of each cycle after Cycle 1; at the end of study treatment.'}, {'measure': 'To evaluate the duration of response (DR), and progression-free survival (PFS)', 'timeFrame': "Each cycle will last 21 days (14 days treatment, 7 days recovery) for a max of 6 cycles. Following discont'n of treatment , pts will be followed for survival status every 2 mos following PD for up to 6 mos."}, {'measure': 'To investigate the relationship of S-1 plasma levels (components and metabolites) with safety and efficacy parameters', 'timeFrame': 'Each cycle will last 21 days (14 days treatment, 7 days recovery) for a max of 6 cycles. Blood samples to be obtained 1.5 ± 0.5 h, 5 ± 1 h, 7 ± 1 h postdose on Day 1 of Cycle 1 only.'}] |
Title: The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER US) | Condition: Liver Neoplasms, Hepatocellular Carcinoma, Liver Metastases | Keywords: | Summary: | Description: This trial is a single arm, non-randomized, multicenter, prospective trial. Following histotripsy treatment of liver tumor(s), subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Subjects will then be followed for 30 days. Additionally, subjects will be evaluated at 6 months and followed annually for up to five (5) years post-index procedure.
The #HOPE4LIVER US trial required pooling data from #HOPE4LIVER US and #HOPE4LIVER EU/UK (NCT04573881). Subjects were treated with the same intervention (HistoSonics System) using identical protocols tailored to the regulatory requirements for each geography. | ArmGroups: [{'label': 'HistoSonics System', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: HistoSonics System']}] | Interventions:[{'type': 'DEVICE', 'name': 'HistoSonics System', 'description': 'The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.', 'armGroupLabels': ['HistoSonics System'], 'otherNames': ['Histotripsy']}] | PrimaryOutcomes: [{'measure': 'Primary Efficacy: Technical Success', 'description': 'Technical success, defined as the treatment volume/treatment dimensions being greater than or equal to the targeted tumor, and with complete tumor coverage, via computed tomography (CT) or magnetic resonance (MR) imaging. \\[Core Laboratory Adjudicated\\] Primary efficacy was assessed per tumor with a performance goal of greater than 70%.\n\nPrimary efficacy was assessed after the first forty (40) consecutive evaluable subjects were enrolled. Evaluable subjects had sufficient CT or MR imaging data to allow the independent core laboratory to evaluate technical success.', 'timeFrame': '≤36 hours post-index procedure'}, {'measure': 'Primary Safety: Procedure-Related Major Complications', 'description': 'Number of index procedure related major complications, including device-related events defined as Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher toxicities observed up to 30-days post index-procedure. \\[Clinical Events Committee Adjudicated\\] Primary safety was assessed per participant with a performance goal of less than 25%.\n\nPrimary safety was assessed on all subjects enrolled, after the first forty (40) consecutive subjects evaluable for technical success were enrolled. Evaluable subjects had sufficient CT or MR imaging data to allow the independent core laboratory to evaluate technical success. Enrollment of 44 total subjects was required to assess forty (40) subjects evaluable for technical success.', 'timeFrame': '30 days post-index procedure'}] | SecondaryOutcomes: [{'measure': 'Technical Success', 'description': 'Technical success, defined as the treatment volume/treatment dimensions being greater than or equal to the targeted tumor, and with complete tumor coverage, via computed tomography (CT) or magnetic resonance (MR) imaging. \\[Core Laboratory Adjudicated\\]', 'timeFrame': '≤36 hours post-index procedure'}, {'measure': 'Procedure-Related Major Complications', 'description': 'Number of index procedure related major complications, including device-related events defined as Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher toxicities observed up to 30-days post index-procedure. \\[Clinical Events Committee Adjudicated\\]', 'timeFrame': '30 days post-index procedure'}, {'measure': 'Secondary Efficacy: Technique Efficacy', 'description': 'Technique efficacy, defined as the lack of a nodular or mass-like area of enhancement within or along the edge of the treatment volume assessed via CT or MR imaging at 30-days post-procedure. \\[Core Laboratory Adjudicated\\]', 'timeFrame': '30 days post-index procedure'}, {'measure': 'Secondary Safety: All Adverse Events', 'description': 'Number of adverse events (serious and non-serious) reported within 30 days post-index procedure. \\[Clinical Events Committee Adjudicated\\]', 'timeFrame': '30 days post-index procedure'}] |
Title: Detection of FGFR Gene Mutations in the Tumor Tissue and Urine of Patients With Urothelial Carcinoma | Condition: Bladder Cancer | Keywords: | Summary: | Description: This study targets 92 patients with urothelial cancer, whose tissue (from scheduled surgery) and urine samples can be obtained, regardless of the treatment stage.
■ Examination Methods
* FGFR mutations in bladder cancer tissues will be analyzed using next-generation sequencing and current companion diagnostic methods.
* FGFR mutations in urine samples obtained from patients with bladder cancer will be analyzed using nanowires.
* Bladder cancer subtyping will be performed by RNA sequencing of tumor tissues or other methods.
* Analysis of paired tissues before and after chemotherapy will be performed on transurethral resection of bladder tumor (TUR-BT) and cystectomy tissues before and after neoadjuvant chemotherapy. | ArmGroups: [{'label': 'BC', 'description': 'Patients who were diagnosed with bladder cancer', 'interventionNames': ['Diagnostic Test: FGFR test']}] | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'FGFR test', 'description': 'Detection of FGFR gene mutations in the tumor tissue and urine of patients', 'armGroupLabels': ['BC']}] | PrimaryOutcomes: [{'measure': 'Correlation between FGFR mutations found in bladder cancer tissues and urine before and after treatment', 'description': 'The ratio of patients with matching test results to total patients', 'timeFrame': 'Up to two weeks before and after surgery'}] | SecondaryOutcomes: [{'measure': 'Changes in FGFR mutations in tissues before and after treatment', 'description': 'Changes in FGFR mutations in tissues before and after treatment will be observed in the patients with muscle-invasive and non-muscle-invasive bladder cancer undergoing neoadjuvant chemotherapy and transurethral bladder tumor resection, respectively, due to recurrence.', 'timeFrame': 'Up to two weeks before and after treatment'}, {'measure': 'Patient prognosis', 'description': 'recurrence-free', 'timeFrame': 'six months and one year after treatment'}, {'measure': 'Patient prognosis', 'description': 'progression-free', 'timeFrame': 'six months and one year after treatment'}, {'measure': 'Patient prognosis', 'description': 'cancer-specific survivals', 'timeFrame': 'six months and one year after treatment'}, {'measure': 'Patient prognosis', 'description': 'overall survivals', 'timeFrame': 'six months and one year after treatment'}, {'measure': 'PD-L1 expression', 'description': 'PD-L1 expression level will be measured using immunohistochemistry, RNA sequencing, and other suitable methods to analyze the bladder cancer subtypes', 'timeFrame': 'Up to two weeks before and after treatment'}] |
Title: A Phase I Trial of the Hypoxia Modifier Atovaquone in Combination With Radical Concurrent Chemoradiotherapy in Locally Advanced Non-Small Cell Lung Cancer | Condition: Locally Advanced Non-Small Cell Lung Cancer | Keywords: | Summary: | Description: Twice daily oral atovaquone will be added to standard concurrent chemoradiotherapy (CRT): 66 Gy in 33 fractions, once daily, 5 days a week (Monday-Friday), with cisplatin (80 mg/m2 IV on days 1 and 22 of CRT) and vinorelbine (15 mg/m2 IV on days 1, 8, 22 and 29 of CRT). Whilst awaiting CRT to start, patients will receive two weeks (+/- 7 days) of oral atovaquone to ensure steady state is reached (after seven days). Patients will be allocated one of four dose levels: 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD). Atovaquone dose will be assigned as per the TiTE-CRM statistical model. The first two trial participants will receive 450 mg BD. In the absence of unacceptable toxicity, subsequent patients will be assigned doses up to and including 750 mg BD.
Hypoxia biomarker data will be collected at baseline (start of atovaquone run-in) and following two weeks (+/- 7 days) of atovaquone treatment. Atovaquone will then be continued without break for the duration of CRT, with the CRT schedule remaining constant for all patients at both centres. Assessment for Dose Limiting Toxicities (DLTs) will be from the first scheduled dose of atovaquone until three months after completion of CRT. The CT scan performed at the three-month follow up visit will be reviewed to collect tumour response data. | ArmGroups: [{'label': 'Dose level 1 - 450 mg BD atovaquone + concurrent CRT', 'type': 'EXPERIMENTAL', 'description': 'Atovaquone:\n\n* Taken during an initial run in period (2 weeks +/- 7 days), then continued during standard of care chemoradiotherapy.\n* One of 4 dose levels is allocated to each patient by a TiTE-CRM statistical model which takes into account all toxicity data to date.\n* Dose levels - 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD).\n* Last dose atovaquone taken on the last day of radiotherapy.\n* Total duration of atovaquone treatment is 59 days (+/- 7 days), unless stopped earlier for toxicity or any other reason.\n\nChemotherapy:\n\n* 2 x 21-day cycles.\n* 80 mg/m2 cisplatin on day 1 and 22 of chemoradiotherapy.\n* 15 mg/m2 vinorelbine on days 1,8, 22 and 29 of chemoradiotherapy.\n\nRadiotherapy:\n\n* 66 Gy in 33 fractions.\n* Delivered once daily, 5 days a week (Monday-Friday) for 6.5 weeks.', 'interventionNames': ['Drug: Atovaquone Oral Suspension', 'Drug: Standard of care chemotherapy', 'Radiation: Standard of care radiotherapy']}, {'label': 'Dose level 2 - 600 mg BD atovaquone + concurrent CRT', 'type': 'EXPERIMENTAL', 'description': 'Atovaquone:\n\n* Taken during an initial run in period (2 weeks +/- 7 days), then continued during standard of care chemoradiotherapy.\n* One of 4 dose levels is allocated to each patient by a TiTE-CRM statistical model which takes into account all toxicity data to date.\n* Dose levels - 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD).\n* Last dose atovaquone taken on the last day of radiotherapy.\n* Total duration of atovaquone treatment is 59 days (+/- 7 days), unless stopped earlier for toxicity or any other reason.\n\nChemotherapy:\n\n* 2 x 21-day cycles.\n* 80 mg/m2 cisplatin on day 1 and 22 of chemoradiotherapy.\n* 15 mg/m2 vinorelbine on days 1,8, 22 and 29 of chemoradiotherapy.\n\nRadiotherapy:\n\n* 66 Gy in 33 fractions.\n* Delivered once daily, 5 days a week (Monday-Friday) for 6.5 weeks.', 'interventionNames': ['Drug: Atovaquone Oral Suspension', 'Drug: Standard of care chemotherapy', 'Radiation: Standard of care radiotherapy']}, {'label': 'Dose level 3 - 675 mg BD atovaquone + concurrent CRT', 'type': 'EXPERIMENTAL', 'description': 'Atovaquone:\n\n* Taken during an initial run in period (2 weeks +/- 7 days), then continued during standard of care chemoradiotherapy.\n* One of 4 dose levels is allocated to each patient by a TiTE-CRM statistical model which takes into account all toxicity data to date.\n* Dose levels - 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD).\n* Last dose atovaquone taken on the last day of radiotherapy.\n* Total duration of atovaquone treatment is 59 days (+/- 7 days), unless stopped earlier for toxicity or any other reason.\n\nChemotherapy:\n\n* 2 x 21-day cycles.\n* 80 mg/m2 cisplatin on day 1 and 22 of chemoradiotherapy.\n* 15 mg/m2 vinorelbine on days 1,8, 22 and 29 of chemoradiotherapy.\n\nRadiotherapy:\n\n* 66 Gy in 33 fractions.\n* Delivered once daily, 5 days a week (Monday-Friday) for 6.5 weeks.', 'interventionNames': ['Drug: Atovaquone Oral Suspension', 'Drug: Standard of care chemotherapy', 'Radiation: Standard of care radiotherapy']}, {'label': 'Dose level 4 - 750 mg BD atovaquone + concurrent CRT', 'type': 'EXPERIMENTAL', 'description': 'Atovaquone:\n\n* Taken during an initial run in period (2 weeks +/- 7 days), then continued during standard of care chemoradiotherapy.\n* One of 4 dose levels is allocated to each patient by a TiTE-CRM statistical model which takes into account all toxicity data to date.\n* Dose levels - 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD).\n* Last dose atovaquone taken on the last day of radiotherapy.\n* Total duration of atovaquone treatment is 59 days (+/- 7 days), unless stopped earlier for toxicity or any other reason.\n\nChemotherapy:\n\n* 2 x 21-day cycles.\n* 80 mg/m2 cisplatin on day 1 and 22 of chemoradiotherapy.\n* 15 mg/m2 vinorelbine on days 1,8, 22 and 29 of chemoradiotherapy.\n\nRadiotherapy:\n\n* 66 Gy in 33 fractions.\n* Delivered once daily, 5 days a week (Monday-Friday) for 6.5 weeks.', 'interventionNames': ['Drug: Atovaquone Oral Suspension', 'Drug: Standard of care chemotherapy', 'Radiation: Standard of care radiotherapy']}] | Interventions:[{'type': 'DRUG', 'name': 'Atovaquone Oral Suspension', 'description': 'Atovaquone, cisplatin and vinorelbine are all considered Investigational Medicinal Products (IMPs) in this trial due to the investigation of these drugs in a novel combination. Patients will be allocated one of four doses of atovaquone: 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD).', 'armGroupLabels': ['Dose level 1 - 450 mg BD atovaquone + concurrent CRT', 'Dose level 2 - 600 mg BD atovaquone + concurrent CRT', 'Dose level 3 - 675 mg BD atovaquone + concurrent CRT', 'Dose level 4 - 750 mg BD atovaquone + concurrent CRT'], 'otherNames': ['Wellvone']}, {'type': 'DRUG', 'name': 'Standard of care chemotherapy', 'description': 'Atovaquone, cisplatin and vinorelbine are all considered Investigational Medicinal Products (IMPs) in this trial due to the investigation of these drugs in a novel combination. Patients will receive two 21-day cycles of cisplatin and vinorelbine chemotherapy, comprising 80 mg/m2 cisplatin on days 1 \\& 22 of their CRT treatment and 15 mg/m2 vinorelbine on days 1, 8, 22 \\& 29.', 'armGroupLabels': ['Dose level 1 - 450 mg BD atovaquone + concurrent CRT', 'Dose level 2 - 600 mg BD atovaquone + concurrent CRT', 'Dose level 3 - 675 mg BD atovaquone + concurrent CRT', 'Dose level 4 - 750 mg BD atovaquone + concurrent CRT'], 'otherNames': ['Cisplatin', 'Vinorelbine']}, {'type': 'RADIATION', 'name': 'Standard of care radiotherapy', 'description': 'Thoracic radiotherapy will commence on day one of chemotherapy and be delivered in 66 Gy in 33 fractions, once daily, 5 days a week (Monday-Friday) for 6.5 weeks.', 'armGroupLabels': ['Dose level 1 - 450 mg BD atovaquone + concurrent CRT', 'Dose level 2 - 600 mg BD atovaquone + concurrent CRT', 'Dose level 3 - 675 mg BD atovaquone + concurrent CRT', 'Dose level 4 - 750 mg BD atovaquone + concurrent CRT']}] | PrimaryOutcomes: [{'measure': 'Number of Dose Limiting Toxicities in Patients Taking Atovaquone in Combination With Radical Concurrent Chemoradiotherapy for Non-small Cell Lung Cancer.', 'description': 'To determine the maximum tolerated dose level (and therefore recommended phase II dose) of atovaquone when administered concomitantly with radical concurrent chemoradiotherapy (CRT) in patients with non-small cell lung cancer (NSCLC). This is the dose of atovaquone associated with no more than 48% dose limiting toxicity (DLT) rate (target toxicity level).', 'timeFrame': 'From first dose of atovaquone to 3-month follow up visit (up to 25 weeks)'}] | SecondaryOutcomes: [{'measure': 'Severity of Worst Adverse Events Per Dose Level of Atovaquone Administered in Combination With Radical Concurrent Chemotherapy for NSCLC According to CTCAE V4.03', 'description': 'Toxicity profile when atovaquone administered in combination with radical concurrent chemotherapy for NSCLC. Worst grade adverse event for each patient by dose schedule (according to the Common Terminology Criteria for Adverse Events, Version 4.03). Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe or medically significant, but not immediately life-threatening); Grade 4 (life-threatening); Grade 5 (death).', 'timeFrame': 'From first dose of atovaquone until last follow up visit at 6 months post completion of CRT (up to 38 weeks)'}, {'measure': "Number of Patients for Whom it Was Possible to Derive a Hypoxia Metagene Signature Score From 3'RNA-Seq of Genetic Material From Archival Tumour Samples", 'description': "To confirm feasibility of measuring hypoxia metagene signature using 3'RNA-Seq on genetic material extracted from diagnostic non-small cell lung tumour samples. The score method was derived by Buffa et al (Buffa et al. Large meta-analysis of multiple cancers reveals a common, compact and highly prognostic hypoxia metagene. Br J Cancer. 2010 Jan 19;102(2):428-35. doi: 10.1038/sj.bjc.6605450).", 'timeFrame': 'At baseline (diagnosis)'}, {'measure': 'Mean Baseline Tumour Hypoxia Level (TBRvol) Assessed by F18-FMISO PET-CT', 'description': "The level of hypoxia in patient tumours was calculated using the Tumour-to-Blood Ratio volume (TBRvol) assessed from the patient's baseline PET scan. This scan was conducted with 18F-labelled fluoromisonidazole (F18-FMISO) which has been shown to selectively bind to hypoxic cells and can be quantified with PET imaging (Koh, et al. Imaging of hypoxia in human tumours with \\[F-18\\]fluoromisonidazole. Int J Radiat Oncol Biol Phys. 1992;22(1)). Tumour outlining of the region of interest on each axial slice was conducted centrally for all patients in consultation with an experienced consultant radiologist and combined to give a volume of interest (VOI). The number of voxels in the VOI with a threshold regional tumor:plasma F18-FMISO ratio of greater than or equal to 1.4 were combined to give the TBRvol (above reference). Patients with a TBRvol at baseline of \\<1.5mL were regarded as unevaluable for later endpoints, so are excluded from the report.", 'timeFrame': 'At baseline (prior to atovaquone treatment)'}, {'measure': 'Mean Baseline Plasma miR-210 Level Assessed Via TaqMan Quantitative PCR', 'description': "MicroRNA-210 (miR-210) has been found to be upregulated in response to hypoxia-inducing factors (Dang and Myers, The Role of Hypoxia-Induced miR-210 in Cancer Progression, Int. J. Mol. Sci., vol 16, 2015). Additionally, elevated serum levels of miR-210 are indicative of poor clinical outcomes in non-small cell lung cancer (He, et al. Clinical Significance of miR-210 and its Prospective Signaling Pathways in Non-Small Cell Lung Cancer. Physiol. Biochem. Int. J. Exp. Cell. Physiol. Biochem. Pharmacol., vol. 46, 2018). RNA was isolated from blood plasma and miR210 level detected using a two-step TaqMan quantitative PCR, using TaqMan probes for miR-210. An endogenous control miRNA (miR-16), plus an exogenous synthetic miRNA (cel-miR-39) were used for normalisation of miR210 counts. This endpoint was assessed in order to investigate a possible alternative to 18F-FMISO PET-CT scan for assessment of patients' tumour hypoxia level.", 'timeFrame': 'At baseline (prior to atovaquone treatment)'}, {'measure': 'Mean Percentage Change in Tumour Hypoxia Level Between Baseline and After Two Weeks (+/- 7 Days) of Atovaquone Treatment', 'description': 'The level of hypoxia (Tumour-to-Blood Ratio volume, TBRvol) in patient tumours was calculated at baseline and following two weeks (+/- 7 days) of atovaquone treatment according to the details given in outcome measure 4. The mean percentage difference in TBRvol between the two timepoints at each dose level of atovaquone was calculated and is reported, below. Patients with a TBRvol at baseline of \\<1.5mL were regarded as unevaluable as it would not be possible to evaluate a reduction in hypoxic volume between this timepoint and the later timepoint. These patients were excluded from the report.', 'timeFrame': 'Between baseline (prior to atovaquone treatment) and following two weeks (+/- 7 days) of atovaquone treatment (up to 21 days)'}, {'measure': 'Mean Percentage Change in Plasma miR-210 Level Between Baseline and After Two Weeks (+/- 7 Days) of Atovaquone Treatment, Assessed Via TaqMan Quantitative PCR', 'description': "The miR-210 in participant plasma samples was calculated at baseline and following two weeks (+/- 7 days) of atovaquone treatment according to the details given in outcome measure 5. The mean percentage difference in miR210 count between the two timepoints for each dose level of atovaquone was calculated and is reported, below. This endpoint was assessed in order to investigate a possible alternative to 18F-FMISO PET-CT scan for assessment of patients' tumour hypoxia level.", 'timeFrame': 'Between baseline (prior to atovaquone treatment) and following two weeks (+/- 7 days) of atovaquone treatment (up to 21 days)'}, {'measure': 'Objective Tumour Response to Treatment With Atovaquone in Combination With Chemoradiotherapy, as Evaluated by CT or PET-CT Scan and Quantified by RECIST 1.1', 'description': 'Efficacy of the combination (atovaquone and chemoradiotherapy), measured by objective tumour response via RECIST 1.1 (Eisenhauer, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247). Scale of response assessed as Progressive Disease (PD) (worst outcome), Stable Disease (SD), Partial Response (PR), Complete Response (CR) (best outcome).', 'timeFrame': 'At 3 months post completion of chemoradiotherapy (up to 25 weeks after first dose of atovaquone)'}] |
Title: Biospecimen Resource for Familial Pancreas Research, a Data and Tissue Registry (Also Known as a Bio-repository, Bio-bank, Data and Tissue Database, Data and Tissue Bank, Etc.) to Help Advance Research in Familial Pancreas Disease | Condition: Familial Pancreatic Cancer | Keywords: family, history, pancreas, cancer, melanoma, genetic | Summary: | Description: OBJECTIVES:
* To collect clinical history, family history, and blood and/or tissue samples from family members of patients diagnosed with pancreatic diseases, pancreatic cancer, or melanoma.
* To learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers.
OUTLINE: Study participants undergo collection of blood and/or tissue samples as well as survey data for inclusion in a familial data and tissue registry. Participants complete two baseline surveys regarding their personal, family, health, and environmental exposure histories and regarding their opinions on cancer and cancer screening. Patients also complete a follow-up survey at 1 year and undergo review of their medical records. | ArmGroups: N/A | Interventions:[{'type': 'OTHER', 'name': 'biologic sample preservation procedure', 'description': 'one blood sample'}, {'type': 'OTHER', 'name': 'medical chart review', 'description': 'confirmation of cancer diagnosis'}, {'type': 'OTHER', 'name': 'survey administration', 'description': 'at baseline enrollment and 12 months post-enrollment'}] | PrimaryOutcomes: [{'measure': 'Collection of familial data and biospecimens in a data and tissue repository for familial pancreas research', 'timeFrame': 'baseline'}] | SecondaryOutcomes: N/A |
Title: Multi-centric, Placebo-controlled Trial of Omega-3 Fatty Acid Supplementation in Weight Maintenance and Preservation of Lean Body Mass, in (Pre)Cachectic Head and Neck Cancer Patients, Undergoing Curative Radio(Chemo)Therapy | Condition: Cancer Cachexia, Head and Neck Cancer | Keywords: head and neck cancer, omega-3 fatty acid supplementation, echium oil, weight loss, cancer cachexia, body composition, biomarker, quality of life | Summary: | Description: Design A prospective, placebo-controlled trial. H\&N cancer patients eligible for curative treatment will be randomised to receive standard nutritional support with placebo (15ml/day Sunflower oil, control group) or nutritional support with omega-3 FA supplementation (15ml/day Echium oil, experimental group) during radio(chemo)therapy. All patients will undergo a nutritional screening (Patient-Generated Subjective Global Assessment), a quality of life evaluation (EORTC QLQ C30 \& HN35) and will be asked to keep a 3-day food diary at the start of their therapy, and again during the 4th week and the end of therapy. Body composition and grip strength will be measured with bio-electrical impedance (BIA) analysis, Dual X-ray absorptiometry (DXA) and the JAMAR® hydraulic hand dynamometer once at baseline, and again in the 4th week of therapy. Blood samples are collected at baseline, and in the 4th week of therapy to (1) verify compliance rate by measuring fatty acid concentration, (2) verify the presence of potential biomarkers that can predict cachexia and (3) to detect the presence of SNPs associated with severe acute dysphagia. Demographic data, tumour characteristics and therapy-related toxicity will also be collected.
Population Newly diagnosed non-metastatic (stage I-IVB) head and neck cancer patients (≥18 or older) eligible for curative primary or adjuvant radiotherapy with or without systemic therapy | ArmGroups: [{'label': 'omega-3 fatty acid supplementation', 'type': 'EXPERIMENTAL', 'description': 'omega-3 fatty acid supplementation (echium oil)', 'interventionNames': ['Dietary Supplement: BioMega SDA®']}, {'label': 'standard nutritional support', 'type': 'PLACEBO_COMPARATOR', 'description': 'sunflower oil supplementation', 'interventionNames': ['Dietary Supplement: Sunflower oil high oleic']}] | Interventions:[{'type': 'DIETARY_SUPPLEMENT', 'name': 'BioMega SDA®', 'description': 'Echium oil, 15ml/day, 2 times per oral 7.5ml sachet/day, during 7-week radio(chemo)therapy', 'armGroupLabels': ['omega-3 fatty acid supplementation']}, {'type': 'DIETARY_SUPPLEMENT', 'name': 'Sunflower oil high oleic', 'description': 'Sunflower oil high oleic, 15ml/day, 2 times per oral 7.5ml sachet/day, during 7-week radio(chemo)therapy', 'armGroupLabels': ['standard nutritional support']}] | PrimaryOutcomes: [{'measure': 'prevention of therapy-related weight loss', 'description': 'difference between body weight at baseline and end of therapy', 'timeFrame': '7 weeks'}] | SecondaryOutcomes: [{'measure': 'determination of beneficial (and possible side) effects of omega-3 FA supplements in general, and specifically on body weight and body composition', 'description': 'measurement of evolution in body composition (baseline - week 4); measurement of evolution in quality of life (baseline - week 4 - end therapy); measurement of adverse events (CTCAE v4.0)in both groups', 'timeFrame': '7 weeks'}, {'measure': 'establish feasibility, variability and distribution of BIA, DXA and JAMAR® as objective measurement tools of body composition', 'description': 'evolution percentage fat and lean mass (baseline - week 4) as determined by Bio-Elektrical Impedance (BIA) and Dual Energy X-ray Absorptiometry (DXA); evolution grip strength (kg) (baseline - week 4) as determined by JAMAR® hydraulic hand dynamometer', 'timeFrame': '7 weeks'}, {'measure': 'identification of potential clinical risk factors of cachexia', 'description': 'identification of nutritional parameters (obtained from validated nutritional screeners and PG-SGA), demographic, tumour and therapy characteristics, physical, emotional, financial, functional, nutritional and psycho-social characteristics (obtained from EORTC QLQ C30 \\& HN35), and body composition measurements (% fat, % lean mass, phase angle obtained from BIA, DXA and hand dynamometer)', 'timeFrame': '7 weeks'}, {'measure': 'evaluation of the use and reliability of different validated nutritional screening tools in this population', 'description': 'screening with Short Nutritional Assessment Questionnaire (SNAQ), Mini-Nutritional Assessment short-form (MNA-SF), Malnutrition Universal screening tool (MUST), Nutritional risk screening (NRS 2002), Malnutrition screening tool (MST) and the nutrition risk score (NRS); nutritional assessment with Patient Generated - Subjective Global Assessment (PG-SGA) as gold standard', 'timeFrame': '7 weeks'}, {'measure': 'identification and evaluation of potential biomarkers for therapy-induced cachexia', 'description': 'identification of serum biomarkers and Single Nucleotide Polymorphisms (SNP)', 'timeFrame': '7 weeks'}, {'measure': 'measurement of difference in quality of life', 'description': 'measurement of quality of life (baseline, week 4, end therapy) with EORTC QLQ C30\\&HN35', 'timeFrame': '7 weeks'}, {'measure': 'dropout and compliance to nutritional supplements', 'description': 'number of sachets consumed; omega-3 fatty acid profile as marker for therapy compliance', 'timeFrame': '7 weeks'}] |
Title: Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer | Condition: Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of iodine I 131 monoclonal antibody CC49-deltaCH2 (deleted CH2 region) in patients with colorectal cancer.
II. Determine the toxic effects, plasma pharmacokinetics, whole body biodistribution, and conjugate stability of this drug in these patients.
III. Determine the ability of this drug to localize to tumor sites in these patients.
IV. Determine the immune response in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients receive a tracer dose of iodine I 131 monoclonal antibody CC49-deltaCH2 IV on day 1 and a therapy dose over 30 minutes on day 8.
Cohorts of 3-5 patients receive escalating doses of iodine I 131 monoclonal antibody CC49-deltaCH2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 5 patients experience grade 3 or greater toxicity while 0-2 of 5 patients experience reversible grade 4 hematologic toxicity.
Patients are followed weekly for a minimum of 7 weeks and then every 6 weeks until disease progression. | ArmGroups: [{'label': 'Treatment (monoclonal antibody)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive a tracer dose of iodine I 131 monoclonal antibody CC49-deltaCH2 IV on day 1 and a therapy dose over 30 minutes on day 8.\n\nCohorts of 3-5 patients receive escalating doses of iodine I 131 monoclonal antibody CC49-deltaCH2 until the MTD is determined. The MTD is defined as the dose at which 3 of 5 patients experience grade 3 or greater toxicity while 0-2 of 5 patients experience reversible grade 4 hematologic toxicity.', 'interventionNames': ['Drug: iodine I 131 monoclonal antibody CC49-deltaCH2']}] | Interventions:[{'type': 'DRUG', 'name': 'iodine I 131 monoclonal antibody CC49-deltaCH2', 'description': 'Given IV', 'armGroupLabels': ['Treatment (monoclonal antibody)'], 'otherNames': ['131I-HuCC49-deltaCH2', '131I-MOAB CC49-deltaCH2']}] | PrimaryOutcomes: [{'measure': 'Maximum tolerated dose of 131I-HuCC49^CH2 based on dose-limiting toxicities', 'timeFrame': '6 weeks'}] | SecondaryOutcomes: [{'measure': 'Immune response', 'timeFrame': 'Up to 54 weeks'}] |
Title: ICICLE- A Study to Investigate the genetiCs of In Situ Carcinoma of the ductaL subtypE | Condition: Breast Cancer | Keywords: ductal breast carcinoma in situ | Summary: | Description: OBJECTIVES:
Primary
* To collect blood and/or tumor tissue of patients with ductal breast carcinoma in situ (DCIS) and their age- and ethnicity-matched controls to identify the inherited variation that predisposes women to develop DCIS.
* To determine the frequency of these variants.
* To determine the effect of these variants on tumor risk.
* To determine the benefit of testing for these variants in the clinical setting so that those at higher risk could be identified, counseled, and screened.
Secondary
* To analyze the acquired genetic changes within DCIS to identify which cases are more likely to develop invasive disease.
OUTLINE: This is a multicenter study.
All participants complete a questionnaire to collect their family history, a brief medical history, and epidemiological data.
Patients undergo collection of blood and/or tumor tissue samples; DNA is extracted for genotyping, comparison of allele and genotype frequencies (polymorphisms), genetic profiling, DNA analysis, and protein analysis. Histopathology reports are also collected. Healthy volunteers undergo collection of blood samples.
PROJECTED ACCRUAL: A minimum of 3,000 patients and 3,000 controls will be accrued for this study. | ArmGroups: N/A | Interventions:[{'type': 'GENETIC', 'name': 'DNA analysis'}, {'type': 'GENETIC', 'name': 'polymorphism analysis'}, {'type': 'GENETIC', 'name': 'protein analysis'}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis'}, {'type': 'OTHER', 'name': 'questionnaire administration'}, {'type': 'OTHER', 'name': 'survey administration'}] | PrimaryOutcomes: [{'measure': 'Collection of blood and/or tumor tissue'}, {'measure': 'Frequency of genetic variants that predispose women to develop ductal carcinoma in situ (DCIS)'}, {'measure': 'Effect of these variants on tumor risk'}, {'measure': 'Benefit of testing for these variants'}] | SecondaryOutcomes: [{'measure': 'Analysis of acquired genetic changes within DCIS'}] |
Title: Impact of Tumor and Stromal Subtypes on Efficacy of Neoadjuvant FOLFIRINOX in Subjects With Non-Metastatic Pancreatic Cancer | Condition: Pancreatic Ductal Adenocarcinoma (PDAC), Cancer of Pancreas, Pancreatic Cancer, Adult, Pancreas Adenocarcinoma, Pancreatic Neoplasms, Pancreatic Cancer Non-resectable, Pancreatic Cancer Resectable | Keywords: Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer Non-resectable, Pancreatic Cancer Resectable, neoadjuvant FOLFIRNOX, FOLFIRINOX, Pancreatic Cancer, Adult | Summary: | Description: This is a single arm, phase II clinical trial designed to assess the impact of tumor and stromal molecular subtypes on the efficacy of neoadjuvant FOLFIRNOX in untreated subjects with resectable, borderline resectable and unresectable locally advanced pancreatic ductal adenocarcinoma (PDAC). Subjects will undergo an EUS-guided core biopsy of the pancreas prior to treatment and after cycle 8 of FOLFIRINOX. Imaging will be performed after every 4 cycles of chemotherapy (8 weeks) and reassessed for resectability after 12 cycles. If patients show a response to treatment that is deemed by the surgical oncologist to be amenable to resection, surgery can be pursued after 8 cycles of therapy. In this case, the remaining 4 cycles of treatment will be given after surgery.
Duration of Therapy:
In the absence of treatment delays due to adverse events, treatment may continue until:
* Disease progression,
* Inter-current illness that prevents further administration of treatment,
* Unacceptable adverse event(s),
* Subject decides to withdraw from the study, or
* General or specific changes in the subject's condition render the subject unacceptable for further treatment in the judgment of the investigator.
Duration of Follow Up:
- Subjects will be followed for 36 months after removal from study treatment or until death, whichever occurs first. Subjects removed from study treatment for unacceptable adverse events will be followed until resolution or stabilization of the adverse event. | ArmGroups: [{'label': 'SingleArm: FOLFIRINOX', 'type': 'EXPERIMENTAL', 'description': 'Subjects will receive FOLFIRINOX as an outpatient every 14 days per community standards of medical care. Protocol-based therapy will continue for 12 cycles (24 weeks) or until disease progression, unacceptable toxicity, study withdrawal, or subject death. Subjects will have the option of surgical resection after 8 cycles of therapy if repeat scans show evidence of resectable disease. The starting doses for mFOLFIRINOX regimen are: oxaliplatin 85 mg/m2, followed by leucovorin 400 mg/m2 given simultaneously with irinotecan 180mg/m2, followed by 5FU 400 mg/m2 bolus and then 2400 mg/m2 via continuous infusion.', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: Leucovorin', 'Drug: Irinotecan Hydrochloride', 'Drug: 5-FU']}] | Interventions:[{'type': 'DRUG', 'name': 'Oxaliplatin', 'description': '85 mg/m2 in 250 cc Dextrose solution given by IV on Day 1 of each 14-day cycle', 'armGroupLabels': ['SingleArm: FOLFIRINOX'], 'otherNames': ['Eloxatin']}, {'type': 'DRUG', 'name': 'Leucovorin', 'description': '400 mg/m2 in 100 cc dextrose solution given with irinotecan by IV on Day 1 of each 14-day cycle', 'armGroupLabels': ['SingleArm: FOLFIRINOX'], 'otherNames': ['folinic acid']}, {'type': 'DRUG', 'name': 'Irinotecan Hydrochloride', 'description': '180 mg/m2 in 500cc dextrose solution given with leucovorin by IV on Day 1 of each 14-day cycle', 'armGroupLabels': ['SingleArm: FOLFIRINOX'], 'otherNames': ['Camptosar']}, {'type': 'DRUG', 'name': '5-FU', 'description': '400 mg/m2 bolus and then 2400 mg/m2 via continuous infusion on Day 1 of each 14-day cycle', 'armGroupLabels': ['SingleArm: FOLFIRINOX'], 'otherNames': ['Adrucil']}] | PrimaryOutcomes: [{'measure': 'Best disease control rate by Pancreatic ductal adenocarcinoma (PDAC) subtype', 'description': 'To evaluate the association between PDAC tumor subtype (particularly basal-like versus classical subtype) and best disease control rate (DCR) after administration of FOLFIRINOX in subjects with non-metastatic pancreatic cancer, DCR is defined as the proportion of patients with either Complete Response (CR), partial response (PR), or stable disease (SD) as determined by RECIST 1.1, Response Evaluation Criteria In Solid Tumors Criteria. CR is defined as disappearance of all target lesions; PR as a \\>=30% decrease in the sum of the longest diameter of target lesions; and SD as no response or less response than Partial or Progressive.', 'timeFrame': '6 months after start of treatment'}] | SecondaryOutcomes: [{'measure': 'Rate of resectability', 'description': 'The number of patients who following treatment with FOLFIRINOX were subsequently deemed to have resectable disease and underwent surgical resection', 'timeFrame': '6 months after the start of treatment'}, {'measure': 'Overall survival', 'description': 'median overall survival (OS) of all patients receiving FOLFIRINOX on study as well as in 1) resectable, 2) borderline resectable and 3) unresectable PDAC, measured from the start of treatment until death from any cause.', 'timeFrame': '3 years'}, {'measure': 'Progression free survival', 'description': 'Median time from start of treatment until death or progression as defined by RECIST 1.1 Criteria, for all patients and with respect to each tumor and stroma subtype. Progressive Disease (PD), is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', 'timeFrame': '3 years'}, {'measure': 'best objective response rate (ORR; complete response (CR) + partial response (PR))', 'description': 'Estimation of the best ORR for all patients and with respect to each tumor and stroma subtype. ORR is defined as the proportion of patients with either Complete Response (CR) or partial response (PR) as determined by RECIST 1.1, Response Evaluation Criteria In Solid Tumors Criteria. CR is defined as disappearance of all target lesions; PR as a \\>=30% decrease in the sum of the longest diameter of target lesions;', 'timeFrame': '6 months from start of study treatment'}, {'measure': 'rate of drug-related grade 3 to 5 adverse events', 'description': 'rate of drug-related grade 3 to 5 adverse events, assessed based upon patient reported toxicity as measured by the NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). The CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.', 'timeFrame': '6 months from the start of treatment'}, {'measure': 'R0 resection rate', 'description': 'The number of patients who underwent surgical resection and whose surgical specimens had a microscopically margin-negative resection (R0).', 'timeFrame': '6 months from start of treatment'}, {'measure': 'proportion of patients whose tumor/stroma subtype changes after treatment with FOLFIRINOX', 'description': 'The proportion of patients whose tumor/stroma subtype changed from baseline after treatment with FOLFIRINOX. This will be calculated separately for tumor and stroma.', 'timeFrame': '6 months from start of treatment'}] |
Title: A Prospective, Single-arm, Exploratory, Phase Ib/II Study of SHR-A1811 Combined with Pyrotinib and Bevacizumab in Advanced Breast Cancer with Brain Metastasis. | Condition: Breast Cancer Metastatic, Breast Cancer Brain Metastases | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'SHR-A1811+pyrotinib', 'type': 'EXPERIMENTAL', 'description': 'In phase Ib, enrolled subjects will received SHR-A1811 combined with pyrotinib at different doses to confirm RP2D and evaluate the safety and tolerance.', 'interventionNames': ['Drug: SHR-A1811', 'Drug: Pyrotinib']}, {'label': 'SHR-A1811+pyrotinib+bevacizumab', 'type': 'EXPERIMENTAL', 'description': 'In phase II, enrolled subjects will received SHR-A1811 combined with pyrotinib and bevacizumab to evaluate the efficacy and safety.', 'interventionNames': ['Drug: SHR-A1811', 'Drug: Bevacizumab', 'Drug: Pyrotinib']}] | Interventions:[{'type': 'DRUG', 'name': 'SHR-A1811', 'description': 'ADC', 'armGroupLabels': ['SHR-A1811+pyrotinib', 'SHR-A1811+pyrotinib+bevacizumab']}, {'type': 'DRUG', 'name': 'Bevacizumab', 'description': 'bevacizumab biosimilar', 'armGroupLabels': ['SHR-A1811+pyrotinib+bevacizumab']}, {'type': 'DRUG', 'name': 'Pyrotinib', 'description': 'anti-HER2 inhibitor', 'armGroupLabels': ['SHR-A1811+pyrotinib', 'SHR-A1811+pyrotinib+bevacizumab']}] | PrimaryOutcomes: [{'measure': 'RP2D in phase Ib', 'description': 'Recommended phase II dose confirmed by maximum tolerated dose (MTD) and tolerance of subjects.', 'timeFrame': 'From the enrolment of the first subject, to the end of Cycle 6 completion or disease progression or dose discontinuation due to AE in the last enrolled subject'}, {'measure': 'CNS-ORR by investigator in phase II', 'description': 'CNS-ORR is the percentage of evaluable patients with a confirmed investigator-assessed CNS response of CR (complete response) or PR (partial response) per RANO-BM.', 'timeFrame': 'At baseline, at the time point of every 6 weeks'}] | SecondaryOutcomes: [{'measure': 'Incidence of dose-limiting toxicity (DLT) in phase Ib', 'description': 'Incidence of DLT', 'timeFrame': 'At the time point of 21 days from first medication'}, {'measure': 'MTD in phase Ib', 'description': 'MTD is the highest dose that does not cause any adverse effects as follows: a) 1 subject experienced the treatment-related serious adverse effects that could endanger the life, cause permanent disability or death; b) 2 of 3 subjects experienced DLTs; c) 1 of the first 3 subjects experienced DLTs, and 1 of the additional 3 subjects at the same dose level experienced DLTs again.', 'timeFrame': 'From the enrolment of the first subject, to the end of Cycle 6 completion or disease progression or dose discontinuation due to AE in the last enrolled subject'}, {'measure': 'Incidence and grade of adverse event (AE) and serious adverse event (SAE) in phase Ib', 'description': 'An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. An SAE is defined as any medical event that results in any of the following outcomes: requires inpatient hospitalization or prolongation of existing hospitalization, disability or incapacity, affects ability to work, a life-threatening adverse event or death, a congenital anomaly.', 'timeFrame': 'From the time of informed consent provided to 3 months after the last dose of study therapy'}, {'measure': 'CNS-ORR per RANO-BM in phase Ib', 'description': 'CNS-ORR is the percentage of evaluable patients with a confirmed CNS response of CR (complete response) or PR (partial response) per RANO-BM.', 'timeFrame': 'At baseline, at the time point of every 6 weeks'}, {'measure': 'CNS-ORR per RECIST v1.1 in phase Ib', 'description': 'CNS-ORR is the percentage of evaluable patients with a confirmed CNS response of CR (complete response) or PR (partial response) per RECIST v1.1.', 'timeFrame': 'At baseline, at the time point of every 6 weeks'}, {'measure': 'CNS-DCR in phase Ib', 'description': 'CNS-DCR is the percentage of evaluable patients with a confirmed CNS response of CR (complete response), PR (partial response) or SD (stable disease) per RECIST v1.1.', 'timeFrame': 'At baseline, at the time point of every 6 weeks'}, {'measure': 'DoR in phase Ib', 'description': 'DoR is the time from the date of first detection of objective response (which is subsequently confirmed) until the date of objective radiographic disease progression.', 'timeFrame': 'up to 2 years'}, {'measure': 'CNS-ORR per RECIST v1.1 in phase II', 'description': 'CNS-ORR is the percentage of evaluable patients with a confirmed CNS response of CR (complete response) or PR (partial response) per RECIST v1.1.', 'timeFrame': 'At baseline, at the time point of every 6 weeks'}, {'measure': 'CNS-DCR in phase II', 'description': 'CNS-DCR is the percentage of evaluable patients with a confirmed CNS response of CR (complete response), PR (partial response) or SD (stable disease) per RECIST v1.1.', 'timeFrame': 'At baseline, at the time point of every 6 weeks'}, {'measure': 'DoR in phase II', 'description': 'DoR is the time from the date of first detection of objective response (which is subsequently confirmed) until the date of objective radiographic disease progression.', 'timeFrame': 'up to 2 years'}, {'measure': 'PFS in phase II', 'description': 'PFS is the time from the date of first dose until the date of objective radiographic disease progression or death (by any cause in the absence of progression).', 'timeFrame': 'up to 2 years'}, {'measure': 'OS in phase II', 'description': 'OS is the time from the date of first dose until the date of death by any cause.', 'timeFrame': 'up to 2 years'}, {'measure': 'Safety in phase II', 'description': 'An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Percentage of participants who experienced an adverse event and discontinued study drug due to an AE.', 'timeFrame': 'From the time of informed consent provided to 30 days after the last dose of study therapy'}] |
Title: A Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study of HM97662 as a Single Agent in Patients With Advanced or Metastatic Solid Tumors | Condition: Advanced or Metastatic Solid Tumors | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'HM97662', 'type': 'EXPERIMENTAL', 'description': 'Tablet, oral administration, once daily (QD), continuous dosing', 'interventionNames': ['Drug: HM97662']}] | Interventions:[{'type': 'DRUG', 'name': 'HM97662', 'description': 'To evaluate the safety, tolerability, preliminary anti-tumor efficacy, PK and PD of HM97662 in solid tumors', 'armGroupLabels': ['HM97662']}] | PrimaryOutcomes: [{'measure': 'Incidence and nature of DLTs', 'timeFrame': 'Days 1-28 of Cycle 1 (DLT assessment period) in Dose-Escalation Part'}, {'measure': 'Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI CTCAE v5.0', 'timeFrame': 'until Safety Follow-up, 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first'}] | SecondaryOutcomes: [{'measure': 'Area under the concentration-time curve (AUC)', 'timeFrame': 'until Cycle 4 Day1 (each cycle is 28 days)'}, {'measure': 'The maximum plasma concentration (Cmax)', 'timeFrame': 'until Cycle 4 Day1 (each cycle is 28 days)'}, {'measure': 'Trough plasma concentration (Ctrough)', 'timeFrame': 'until Cycle 4 Day1 (each cycle is 28 days)'}, {'measure': 'Time to reach Cmax (Tmax)', 'timeFrame': 'until Cycle 4 Day1 (each cycle is 28 days)'}, {'measure': 'Terminal Half-life (T1/2)', 'timeFrame': 'until Cycle 4 Day1 (each cycle is 28 days)'}, {'measure': 'Apparent clearance (CL/F)', 'timeFrame': 'until Cycle 4 Day1 (each cycle is 28 days)'}, {'measure': 'Apparent volume of distribution (Vd/F)', 'timeFrame': 'until Cycle 4 Day1 (each cycle is 28 days)'}, {'measure': 'Objective response', 'timeFrame': 'Day 1 of Cycles 3, 5, 7 (each cycle is 28 days) and further (every 8 weeks) until disease progression (assessed up to 5 years)'}] |
Title: General Anesthesia or Combined Spinal-epidural Anesthesia With Ketofol Sedation in Colon Cancer Surgery? | Condition: Colon Cancer, Anesthesia | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'general anesthesia group', 'description': 'Patients in this group will undergo open colon cancer surgery under general anesthesia. Epidural catheterization will be applied for postoperative analgesia.'}, {'label': 'combined spinal-epidural anesthesia group', 'description': 'Patients in this group will undergo open colon cancer surgery under combined spinal-epidural anesthesia with ketofol sedation. Epidural catheterization will be applied for postoperative analgesia.', 'interventionNames': ['Other: combined spinal-epidural anesthesia']}] | Interventions:[{'type': 'OTHER', 'name': 'combined spinal-epidural anesthesia', 'description': 'Combined spinal and epidural anaesthesia is a regional anaesthetic technique, which combines the benefits of both spinal anaesthesia and epidural anaesthesia and analgesia. The spinal component gives a rapid onset of a predictable block. The indwelling epidural catheter gives the ability to provide long lasting analgesia and to titrate the dose given to the desired effect.', 'armGroupLabels': ['combined spinal-epidural anesthesia group']}] | PrimaryOutcomes: [{'measure': 'visual analog scale (VAS)', 'description': "A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score).", 'timeFrame': 'postoperative 2nd hour.'}, {'measure': 'visual analog scale (VAS)', 'description': "A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score).", 'timeFrame': 'postoperative 4th hour.'}, {'measure': 'visual analog scale (VAS)', 'description': "A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score).", 'timeFrame': 'postoperative 8th hour.'}, {'measure': 'visual analog scale (VAS)', 'description': "A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score).", 'timeFrame': 'postoperative 12th hour.'}, {'measure': 'visual analog scale (VAS)', 'description': "A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score).", 'timeFrame': 'postoperative16th hour.'}, {'measure': 'visual analog scale (VAS)', 'description': "A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score).", 'timeFrame': 'postoperative 24th hour.'}, {'measure': 'time to start oral intake', 'description': 'the time the patient start to consume orally after the operation', 'timeFrame': 'to be observed until the start of oral intake after the operation. it will be assessed up to 720 hours.'}, {'measure': 'mobilization time', 'description': 'the time the patient was start to walk after the operation', 'timeFrame': 'to be observed until the start of walking after the operation. it will be assessed up to 720 hours.'}, {'measure': 'urinary catheter withdrawal time', 'description': 'the time the urinary catheter was withdrawn after the operation', 'timeFrame': 'to be observed until the withdrawal of urinary catheter after the operation. it will be assessed up to 720 hours.'}, {'measure': 'hospitalization time', 'description': 'The time from the day the patient was hospitalized before the operation to the day of discharge after the operation.', 'timeFrame': 'from hospitalization for the operation to the day of discharge, it will be assessed up to 30 days.'}, {'measure': 'nasogastric withdrawal time', 'description': 'the time the nasogastric tube was withdrawn after the operation.', 'timeFrame': 'to be observed until the withdrawal of nasogastric tube after the operation. it will be assessed up to 720 hours.'}, {'measure': 'drain removal time', 'description': 'the time the abdominal drain was withdrawn after the operation.', 'timeFrame': 'to be observed until the withdrawal of abdominal drain after the operation. it will be assessed up to 720 hours.'}, {'measure': 'complications', 'description': 'all complications related with surgery or anesthesia', 'timeFrame': 'to be observed for 30 days postoperatively.'}, {'measure': 'blood pressure', 'description': "patients' mean arterial pressure levels", 'timeFrame': 'preoperatively'}, {'measure': 'blood pressure', 'description': "patients' mean arterial pressure levels", 'timeFrame': 'perioperatively. "30 minutes" will be taken as the measurement period.'}, {'measure': 'FiCO2', 'description': 'inspiratory carbondioxide level', 'timeFrame': 'preoperatively'}, {'measure': 'FiCO2', 'description': 'inspiratory carbondioxide level', 'timeFrame': 'perioperatively. "30 minutes" will be taken as the measurement period.'}, {'measure': 'sPO2', 'description': 'oxygene saturation', 'timeFrame': 'preoperatively'}, {'measure': 'sPO2', 'description': 'oxygene saturation', 'timeFrame': 'perioperatively. "30 minutes" will be taken as the measurement period.'}] | SecondaryOutcomes: N/A |
Title: Metabolic Phenotyping of Blood Plasma by Means of 1H-NMR Spectroscopy: a New Tool to Detect Colorectal Cancer? | Condition: Colorectal Cancer | Keywords: biomarker, screening, coloscopy | Summary: | Description: Colorectal cancer is one of the most common and deadliest cancers worldwide. Since tumor stage at time of diagnosis is a critical determinant of patient outcome, early detection of colorectal cancer by screening modalities holds the key to improving patient survival. However, current tests, i.e. fecal occult blood testing and colonoscopy, are inadequate for first line screening of colorectal cancer due to limited accuracy and low participation rates, respectively. Therefore, there is an urgent need for new and accurate tests that can be used for en masse screening of colorectal cancer. A blood-based test represents a promising alternative as it takes little time, poses minimal risk to the patient, and is therefore very likely to lead to high participation rates. The development of an effective blood-based screening tool is based on the identification of biomarkers in the blood that are sensitive and specific for colorectal cancer. Studying the metabolic phenotype of colorectal cancer may help to identify such biomarkers since the metabolism of cancer cells is known to differ significantly from that of normal cells. More specifically, the entire metabolism of cancer cells is reprogrammed to increase anabolic reactions that favor cell growth and cell survival.
The hypothesis of the present study is that metabolic phenotyping of blood plasma allows to (i) discriminate between colorectal cancer patients and control subjects and (ii) identify new biomarkers for colorectal cancer. In order to test this hypothesis, The investigators will apply proton nuclear magnetic resonance (1H-NMR) spectroscopy to perform metabolic phenotyping of blood plasma in 50 colorectal cancer patients and 50 control subjects. Multivariate statistics will be performed to assess the discriminative power of the applied methodology in distinguishing between both groups and to identify metabolites with potential as biomarkers for colorectal cancer. | ArmGroups: [{'label': 'Control group-Blood sampling', 'description': '-subjects with a normal colonoscopy', 'interventionNames': ['Other: Control group-Blood sampling', 'Other: Blood sampling']}, {'label': 'Study group-Blood sampling', 'description': '- subjects with colorectal cancer after colonoscopy', 'interventionNames': ['Other: Control group-Blood sampling', 'Other: Blood sampling']}] | Interventions:[{'type': 'OTHER', 'name': 'Control group-Blood sampling', 'description': 'Determine the metabolic phenotype of blood plasma by NMR spectroscopy', 'armGroupLabels': ['Control group-Blood sampling', 'Study group-Blood sampling'], 'otherNames': ['Metabolic phenotype']}, {'type': 'OTHER', 'name': 'Blood sampling', 'description': 'determine amount and type of free circulating miRNA in blood plasma', 'armGroupLabels': ['Control group-Blood sampling', 'Study group-Blood sampling'], 'otherNames': ['free circulating miRNA']}] | PrimaryOutcomes: [{'measure': 'metabolic phenotype of colorectal cancer', 'description': 'Significant metabolic changes in blood plasma of colorectal cancer patients compared with control subjects', 'timeFrame': 'day 1'}] | SecondaryOutcomes: [{'measure': 'tumor histology', 'description': 'subtype of histology of the colorectal tumor (according to WHO histological classification of tumors of the colon and rectum)', 'timeFrame': 'day 1'}, {'measure': 'tumor stage', 'description': 'stage of the colorectal tumor, defined by the TNM classification system (7th edition)', 'timeFrame': 'Day 1'}] |
Title: A Phase II Study Of Paclitaxel, Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-IV | Condition: Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer | Keywords: stage II ovarian epithelial cancer, stage I ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer | Summary: | Description: OBJECTIVES:
* Determine the tolerability and toxicity of paclitaxel, carboplatin, and gemcitabine in patients with previously untreated stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma.
* Determine the response rate of patients treated with this regimen.
* Determine the time to progression and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 and 6 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study. | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'carboplatin'}, {'type': 'DRUG', 'name': 'gemcitabine hydrochloride'}, {'type': 'DRUG', 'name': 'paclitaxel'}] | PrimaryOutcomes: [{'measure': 'Evaluation of tolerability and toxicity of the combination therapy with paclitaxel, carboplatin and gemcitabine (P-C-G) in first line treatment of ovarian cancer patients. Evaluation of Drop-out rate due to toxicity', 'description': 'The decision level is reached, when the lower exact 95% confidence limit of the observed proportion is higher than the upper exact 95% confidence limit of the historical proportion, which corresponds to a power of 0.5 applying a significance level of 0.05', 'timeFrame': 'Based on decision level'}] | SecondaryOutcomes: N/A |
Title: Camrelizumab Combined With Intraperitoneal Infusion of Nab-paclitaxel, Intravenous Chemotherapy and S-1 in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis：Single-arm, Prospective Clinical Study | Condition: Stage IV Gastric Cancer With Metastasis | Keywords: Camrelizumab, Nab-paclitaxel, Peritoneal Metastasis, Intraperitoneal Infusion | Summary: | Description: The incidence of gastric cancer in China is high. Although the guidelines have recommended standard first and second-line chemotherapy, the survival rate of patients with advanced gastric cancer with peritoneal metastasis is still low.Nab-paclitaxel is a taxane drug, because of its binding to albumin, it does not need pretreatment before infusion, which is convenient for infusion, and has great application prospects in the treatment of advanced gastric cancer. There are positive expectations regarding the safety and efficacy of the combination. With the deepening of the understanding of the body's immune system and the rapid development of biotechnology, immunotherapy has become an important means of tumor treatment, and occupies an increasingly important position in the comprehensive tumor treatment system. At the same time, a number of studies have confirmed that camrelizumab combined with chemotherapy has a better therapeutic effect in gastric cancer, and the safety is tolerable.
In summary, how to improve the short-term and long-term efficacy of gastric cancer with peritoneal metastasis, while improving patient tolerance as much as possible and reducing adverse reactions, is an urgent problem to be solved. The purpose of this study was to evaluate the efficacy of camrelizumab combined with nab-paclitaxel intraperitoneal infusion, intravenous chemotherapy and S-1 in the treatment of advanced gastric cancer with peritoneal metastasis, so as to preliminarily explore the feasibility of the three-drug combination regimen in patients with gastric cancer with peritoneal metastasis and safety, and strive to maximize the benefits of different groups of people. | ArmGroups: [{'label': 'Experimental group', 'type': 'EXPERIMENTAL', 'description': 'Camrelizumab: 200 mg, intravenous infusion, d1, q3w;\n\nNab-paclitaxel: 130 mg/m2 intraperitoneal and 130 mg/m2 intravenously, d1, q3w;\n\nS-1: calculated based on body surface area Dosage, twice a day, orally, d1-d14, q3w;', 'interventionNames': ['Drug: Camrelizumab; Nab-paclitaxel; S-1']}] | Interventions:[{'type': 'DRUG', 'name': 'Camrelizumab; Nab-paclitaxel; S-1', 'description': "Camrelizumab: 200 mg, intravenous infusion, d1, q3w;\n\nNab-paclitaxel: 130 mg/m2 intraperitoneal and 130 mg/m2 intravenously, d1, q3w;\n\nS-1: calculated based on body surface area Dosage, twice a day, orally, d1-d14, q3w;\n\nThe dosage can be adjusted according to the protocol according to the adverse reactions of subjects. Subjects will continue to take medication until completion of the prescribed course of treatment, disease progression, toxicity intolerance, withdrawal of Informed Consent Form, or termination in the investigator's judgment.", 'armGroupLabels': ['Experimental group'], 'otherNames': ['Arm PD-1']}] | PrimaryOutcomes: [{'measure': 'Progression Free Survival(PFS)', 'description': 'Defined as the time from the date of informed consent to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first.', 'timeFrame': '24 months'}] | SecondaryOutcomes: [{'measure': 'Overall survival (OS)', 'description': 'Defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.', 'timeFrame': '24 months'}, {'measure': 'Peritoneal Cancer Index (PCI) assessed on preoperative CT (CT-PCI)', 'timeFrame': '24 months'}] |
Title: A Study to Evaluate the Long-Term Safety of CLBR001, A Lentiviral Based Chimeric Antigen Receptor, In Patients With B-Cell Malignancies Previously Administered CLBR001 | Condition: Relapsed/Refractory B-cell Lymphomas, Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Chronic Lymphocytic Leukemia (CLL), Marginal Zone Lymphoma (MZL), Mantle Cell Lymphoma (MCL), Small Lymphocytic Lymphoma (SLL), Primary Mediastinal Large B Cell Lymphoma, Transformed Follicular Lymphoma, Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma, Burkitt Lymphoma | Keywords: CAR-T Cell Therapy, Switchable CAR-T Cell, Autologous Cell Therapy, CD19 Positive Disease, Blood Cancer, Hematological malignancy, Neoplasms, CD19 CAR-T Cell, Long Term Follow Up (LTFU) | Summary: | Description: Patients will be enrolled following either the completion or early termination/discontinuation from Study NCT04450069 or any protocol in which patients were administered CLBR001. Patients will begin the long-term follow-up period regardless of whether they responded to treatment or progressed on treatment. Patients will be followed for up to 15 years post CLBR001 infusion and will continue to be monitored for safety, immunogenicity, and efficacy. | ArmGroups: [{'label': 'CLBR001 treated patients', 'type': 'EXPERIMENTAL', 'description': 'Patients who have been administered with CLBR001', 'interventionNames': ['Combination Product: CLBR001 and SWI019']}] | Interventions:[{'type': 'COMBINATION_PRODUCT', 'name': 'CLBR001 and SWI019', 'description': 'No study drug is administered in this study. Patients who have received CLBR001 autologous CAR-T cells will be evaluated in this trial for long-term safety and efficacy', 'armGroupLabels': ['CLBR001 treated patients']}] | PrimaryOutcomes: [{'measure': 'Incidence and duration of new adverse events, late onset adverse events, and events of special interest', 'description': 'To measure the incidence and duration of new adverse events, late onset adverse events, and events of special interest', 'timeFrame': '15 years'}, {'measure': 'Incidence and duration of new serious adverse events', 'description': 'To measure the incidence and duration of new serious adverse events', 'timeFrame': '15 years'}, {'measure': 'Incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001', 'description': 'The measure the incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001', 'timeFrame': '15 years'}, {'measure': 'Incidence of new malignancies', 'description': 'The measure the incidence of new malignancies', 'timeFrame': '15 years'}] | SecondaryOutcomes: [{'measure': 'Overall response', 'description': 'To evaluate clinical efficacy by measuring the overall response by Response Evaluation Criteria In Lymphoma (RECIL) 2017', 'timeFrame': '15 years'}, {'measure': 'Duration of response', 'description': 'To evaluate clinical efficacy by measuring the duration of response', 'timeFrame': '15 years'}, {'measure': 'Progression free survival', 'description': 'To evaluate clinical efficacy by measuring progression free survival', 'timeFrame': '15 years'}, {'measure': 'Proportion of patients undergoing stem cell transplant', 'description': 'To evaluate the proportion of patients undergoing stem cell transplant', 'timeFrame': '15 years'}, {'measure': 'Number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens', 'description': 'To measure the number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens', 'timeFrame': '3, 6, 9,12 and 24 months'}, {'measure': 'Detectable replication competent lentivirus (RCL)', 'description': 'To measure detectable replication competent lentivirus (RCL)', 'timeFrame': '15 years'}, {'measure': 'Titer of anti-drug antibody (ADA) for CLBR001 and SWI019', 'description': 'To evaluate immunogenicity by measuring the titer of ADA for CLBR001 and SWI019', 'timeFrame': '3, 6, 12 months'}, {'measure': 'Duration of detection of ADA for CLBR001 and SWI019', 'description': 'To evaluate immunogenicity by measuring the duration of detection of ADA for CLBR001 and SWI019', 'timeFrame': '3, 6, 12 months'}] |
Title: Robot-Assisted or Laparoscopic Resection for Gastric Subepithelial Tumor With Hand-Sewn Repair, a Case Series | Condition: Gastric Mass | Keywords: | Summary: | Description: : A retrospective chart review was made of all patients who presented with gastric subepithelial tumor and underwent laparoscopic or robotic resection at Ramathibodi Hospital during 2012-2018. Surgical outcomes and complication of gastotomy and hand-sewn repair were analyzed. | ArmGroups: N/A | Interventions:[{'type': 'PROCEDURE', 'name': 'Hand-Sewn Repair', 'description': 'gastotomy to identify and remove gastric subepithelium tumor and hand sawn repair'}] | PrimaryOutcomes: [{'measure': 'Post operative complication', 'description': 'anastomosis leak', 'timeFrame': '7 day'}, {'measure': 'Post operative compliction', 'description': 'wound infection', 'timeFrame': '7 day'}] | SecondaryOutcomes: [{'measure': 'Surgical outcome', 'description': 'Complete remove mass with out rupture', 'timeFrame': '7 day'}] |
Title: Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival in Older Patients Having Major Cancer Surgery: A Multicenter Randomized Trial | Condition: Hypothermia, Delirium, Long-term Survivors, Cancer Surgery | Keywords: Hypothermia, Delirium, Cancer surgery, Long-term survival | Summary: | Description: Perioperative hypothermia results from anesthetic-impaired thermoregulatory responses combined with cool operating rooms and exposed body cavities. Core temperatures \<35.5°C increases perioperative blood loss, delays post anesthetic recovery, and increases surgical wound infections.
Despite guideline recommendations, compliance with intraoperative temperature monitoring and management remains poor. In a national survey published in 2017, intraoperative hypothermia (core temperature \<36.0°C) occurred in 44% of patients having elective surgery with general anesthesia. According to a survey of anesthesiologists in six Asia-Pacific countries (Singapore, Malaysia, Philippines, Thailand, India, and South Korea), only 67% of respondents measured temperature intraoperatively during general anesthesia, and only 44% report intraoperative active warming and warming was ineffective in more than half of their patients. Perioperative hypothermia thus remains common.
The 5,056-patient PROTECT trial showed that myocardial injury, surgical site infections, and blood loss were similar in patients randomized to intraoperative core temperatures of 35.5 or 37°C. However, there are other important complications that may be caused by intraoperative hypothermia including delirium, cancer recurrence, shivering, and thermal discomfort.
Perioperative neurocognitive disorders (NCDs), especially postoperative delirium and postoperative cognitive dysfunction (POCD), are significant challenges to older patients scheduled for surgery. Delirium is a syndrome of acutely occurring and fluctuating changes in attention, level of consciousness, and cognitive function. Postoperative cognitive dysfunction refers to cognitive decline (including the ability of study, memory, action, and judgement) detected from 30 days to 12 months after surgery.
In patients aged 60 years or above, the incidence of postoperative delirium is about 12-24%. The incidence of POCD is about 7-12% at 3-month follow-up and is associated with delirium, although the relationship is probably not causal. Delirium and POCD are associated with worse perioperative outcomes including prolonged hospitalization, increased complications, and high mortality, and worse long-term outcomes including shortened overall survival, as well as increased dementia and lowered life quality.
Postoperative delirium and POCD are multifactorial. Predisposing factors include advanced age, lower educational level, cognitive impairment, comorbidities (e.g., cerebrovascular disease, diabetes, and kidney disease), alcohol abuse, and malnutrition. Precipitating factors include deep anesthesia, opioid use, benzodiazepines, intraoperative blood loss/blood transfusion, and severe pain. Hypothermia may also increase the risk of delirium.
Hypothermia provokes both autonomic and behavioral protective responses. The first autonomic response is arterio-venous shunt constriction. Thermoregulatory vasoconstriction occurs many times a day in a typical hospital environment. It is highly effective, but does not usually disturb people and is generally considered to be of little consequence. Shivering is the other primary autonomic thermoregulatory defense against cold and has a triggering threshold about 1°C below the core temperature that triggers vasoconstriction. Unlike vasoconstriction, shivering is uncomfortable for patients. Furthermore, it is accompanied by a tripling of catecholamine concentrations, hypertension, and tachycardia. Behavioral thermoregulatory defenses are mediated by thermal comfort, and provoke voluntary defensive measures such as putting on a sweater, open windows, etc. Behavioral defenses include air conditioning and building shelters and are thus far stronger than autonomic responses. Thermal comfort matters to patients and is thus worth evaluating.
Despite advances in surgery and oncology, postoperative survival decreases about 10% per year, mainly due to cancer recurrence. The development of cancer recurrence mainly depends on the balance between the invasive ability of residual cancer cells and the anti-cancer immune function. Perioperative hypothermia increases stress responses and provokes immune suppression.
The investigators therefore propose to determine whether intraoperative targeted temperature management decreases the incidence of delirium, improves thermal comfort, reduces postoperative shivering, and improves long-term survival in older patients recovering from major cancer surgery. Specifically, the investigators will test the primary short-term hypothesis that perioperative normothermia (core temperature near 36.8°C) reduces delirium over the initial 4 postoperative days. Secondary short-term hypotheses are that perioperative normothermia improves thermal comfort, reduces shivering, and reduces delayed neurocognitive recovery. The primary long-term hypothesis is that perioperative normothermia improves progression-free survival. | ArmGroups: [{'label': 'Routine thermal management', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients assigned to routine thermal management will not be pre-warmed and ambient intraoperative temperature will be maintained near 20°C per routine. Only transfused blood will be warmed. An upper- or lower-body forced-air cover will be positioned over an appropriate non-operative site but will not initially be activated. Should core temperature decrease to 35.5°C, the warmer will be activated as necessary to prevent core temperature from decreasing further. The target nasopharyngeal temperature is 35.5°C.', 'interventionNames': ['Other: Routine thermal management']}, {'label': 'Target temperature management', 'type': 'EXPERIMENTAL', 'description': 'Pre-warming is performed with a full-body forced-air cover and electrically heated blanket for about 30 minutes before induction of anesthesia. The warmer will initially be set to "high" which corresponds to about 43°C. It will be subsequently adjusted to make patients feel warm, but not uncomfortably so. Patients will be warmed during surgery using two forced-air covers or combining forced-air covers with electric heating blanket when clinically practical. All intravenous fluids will be warmed to body temperature. There is no need to control ambient temperature since ambient temperature has little effect on core temperature in patients warmed with forced air. The target nasopharyngeal temperature is 36.8°C.', 'interventionNames': ['Other: Target temperature management']}] | Interventions:[{'type': 'OTHER', 'name': 'Routine thermal management', 'description': 'Patients assigned to routine thermal management will not be pre-warmed and ambient intraoperative temperature will be maintained near 20°C per routine. Only transfused blood will be warmed. An upper- or lower-body forced-air cover will be positioned over an appropriate non-operative site but will not initially be activated. Should core temperature decrease to 35.5°C, the warmer will be activated as necessary to prevent core temperature from decreasing further. The target nasopharyngeal temperature is 35.5°C.', 'armGroupLabels': ['Routine thermal management']}, {'type': 'OTHER', 'name': 'Target temperature management', 'description': 'Pre-warming is performed with a full-body forced-air cover and electrically heated blanket for about 30 minutes before induction of anesthesia. The warmer will initially be set to "high" which corresponds to about 43°C. It will be subsequently adjusted to make patients feel warm, but not uncomfortably so. Patients will be warmed during surgery using two forced-air covers or combining forced-air covers with electric heating blanket when clinically practical. All intravenous fluids will be warmed to body temperature. There is no need to control ambient temperature since ambient temperature has little effect on core temperature in patients warmed with forced air. The target nasopharyngeal temperature is 36.8℃.', 'armGroupLabels': ['Target temperature management']}] | PrimaryOutcomes: [{'measure': 'Incidence of delirium within 4 days after surgery', 'description': 'Occurrence of delirium during the first four postoperative days is assessed with the 3D-Confusion Assessment Method or Confusion Assessment Method for the Intensive Care Unit (for intubated patients) twice daily (8-10 am and 6-8 pm). Immediately before assessing delirium, sedation or agitation is assessed with the Richmond Agitation-Sedation Scale (RASS; scores range from -5 \\[unarousable\\] to +4 \\[combative\\] and 0 indicates alert and calm). Deeply sedated or unarousable patients (RASS -4 or -5) is recorded as comatose and not assessed for delirium.', 'timeFrame': 'During the first four days after surgery.'}, {'measure': 'Progression-free survival after surgery', 'description': 'Time interval from index surgery to cancer recurrence/metastasis/progression or all-cause death, whichever comes first.', 'timeFrame': 'Up to 2 years after surgery of the last enrolled patient.'}] | SecondaryOutcomes: [{'measure': 'Postoperative thermal comfort', 'description': 'Postoperative thermal comfort is evaluated with the Numerical Rating Scale (NRS; an 11-point scale where 0=intense cold, 5=thermal comfort, and 10=intense warm). For patients who are extubated in the operation room, evaluation is conducted at 5 and 30 minutes after arriving post-anesthesia care unit (PACU)/intensive care unit (ICU). For patients who are admitted to PACU/ICU with endotracheal intubation, evaluation is conducted at 5 and 30 minutes after extubation.', 'timeFrame': 'Up to 30 minutes after arriving PACU/ICU or after extubation.'}, {'measure': 'Postoperative shivering intensity', 'description': 'Postoperative shivering intensity is evaluated with a four-point scale (0=no shivering, 1=intermittent, mild shivering, 2=moderate shivering, and 3=persistent, intense shivering). For patients who are extubated in the operation room, evaluation is conducted at 5 and 30 minutes after arriving post-anesthesia care unit (PACU)/intensive care unit (ICU). For patients who are admitted to PACU/ICU with endotracheal intubation, evaluation is conducted at 5 and 30 minutes after extubation.', 'timeFrame': 'Up to 30 minutes after arriving PACU/ICU or after extubation.'}, {'measure': 'Incidence of delayed neurocognitive recovery', 'description': 'Cognitive function will be assessed with the Telephone Montreal Cognitive Assessment (T-MoCA; scores range from 0 to 22, with higher score indicating better function) before surgery and at 30 days after surgery. A T-MoCA score reduction of 1 standard deviation (SD) or more from baseline will be considered the occurrence of delayed neurocognitive recovery.', 'timeFrame': 'At 30 days after surgery.'}, {'measure': 'Incidence of postoperative neurocognitive disorders', 'description': 'Cognitive function will be assessed with the Telephone Montreal Cognitive Assessment (T-MoCA; scores range from 0 to 22, with higher score indicating better function) before surgery and at 6 months and 12 months after surgery. A T-MoCA score reduction of 1 standard deviation (SD) or more from baseline will be considered as the occurrence of postoperative neurocognitive disorders.', 'timeFrame': 'At 6 months and 12 months after surgery.'}] |
Title: Evaluate Safety and Tolerability and Compare Absorption/Distribution Kinetics of a Single 100 Mcg Dose of Fentanyl Sublingual Spray (Fentanyl SL Spray) in Cancer Subjects With or Without Oral Mucositis | Condition: Mucositis, Pain, Unspecified Adult Solid Tumor, Protocol Specific | Keywords: mucositis, unspecified adult solid tumor, protocol specific, pain | Summary: | Description: RATIONALE: One dose of fentanyl sublingual spray may be effective in relieving pain in opioid-tolerant cancer patients.
PURPOSE: This phase III trial is studying the side effects of fentanyl sublingual spray and to see how well it works in treating opioid-tolerant cancer patients with or without oral mucositis.
OBJECTIVES:
Primary
* To compare the absorption/distribution kinetics of a single dose of fentanyl sublingual spray in opioid-tolerant cancer patients with or without oral mucositis.
* To evaluate the safety and tolerability of this regimen.
OUTLINE: This is a multicenter study.
Patients fast for at least 8 hours before and at least 4 hours after and no water is allowed for at least 1 hour before and at least 1 hour after study drug administration. Patients receive a single dose of fentanyl sublingual spray while in an upright position in clinical care recliners or beds, and remain in an upright posture for at least 4 hours after administration. Patients are instructed not to swallow for at least 5 minutes after administration and not to expectorate the drug.
After study drug administration, 10 blood samples are collected over a 12-hour period for pharmacokinetic and other analyses. | ArmGroups: [{'label': 'Fentanyl sublingual spray 100 µg', 'type': 'EXPERIMENTAL', 'description': 'Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.', 'interventionNames': ['Drug: Fentanyl sublingual spray']}] | Interventions:[{'type': 'DRUG', 'name': 'Fentanyl sublingual spray', 'description': 'Fentanyl was supplied in single-dose glass vials assembled into a delivery device to be used as a sublingual spray.', 'armGroupLabels': ['Fentanyl sublingual spray 100 µg']}] | PrimaryOutcomes: [{'measure': 'Cmax of Fentanyl', 'description': 'Cmax is defined as the maximum drug concentration in plasma and was determined from individual plasma concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.', 'timeFrame': 'Pre-dose to 12 hours post-dose'}] | SecondaryOutcomes: [{'measure': 'Tmax of Fentanyl', 'description': 'Tmax is defined as the time to reach the maximum concentration of fentanyl in plasma and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.', 'timeFrame': 'Pre-dose to 12 hours post-dose'}, {'measure': 'AUC0-last of Fentanyl', 'description': 'AUC0-last is defined as the area under the plasma concentration-time curve from time-zero to the time of the last quantifiable concentration of fentanyl, was calculated using the linear trapezoidal rule, and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.', 'timeFrame': 'Pre-dose to 12 hours post-dose'}] |
Title: Non-contrast MR Imaging for Whole Body Cancer Detection and Characterization | Condition: Prostate Cancer | Keywords: Prostate Cancer, Restriction spectrum imaging, Magnetic resonance imaging, MRI, RSI | Summary: | Description: Participants will undergo a whole body non-contrast MRI study with a whole-body protocol incorporating routine clinical sequences as well as non-contrast research sequences. The patient will also undergo clinically indicated standard-of-care imaging such as PET/CT, CT, Technetium-99m bone scan or MRI with contrast as determined by the patient's oncologist. When the standard-of-care imaging has not yet been performed upon enrollment, the research MRI will ideally be performed on the same day as the standard-of-care exam. However, scheduling constraints and patient time constraints may preclude scheduling both scans on the same day. In this case, the scans will be performed within a week 90 days of each other. An experienced radiologist will read both scans and results will be provided to the patient's oncologist for clinical follow up.
Patients receiving additional standard-of-care imaging within 12 months after the research MRI may be asked to return for an additional whole body MRI scan within 90 days of their standard-of-care scan. The additional research scan will be requested of patients that have evidence of progression during ongoing standard of care treatment and monitoring. The additional scan would be requested of those patients to compare baseline scans to those that are completed during standard of care imaging. This would be an additional tool to verify disease progression or treatment response. | ArmGroups: [{'label': 'Whole Body Non-Contrast MRI', 'type': 'EXPERIMENTAL', 'interventionNames': ['Diagnostic Test: Whole Body Non-Contrast MRI']}] | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'Whole Body Non-Contrast MRI', 'description': 'Whole Body Non-Contrast MRI in Prostate Cancer Patients', 'armGroupLabels': ['Whole Body Non-Contrast MRI']}] | PrimaryOutcomes: [{'measure': 'Specificity and Sensitivity of Whole Body MRI in Relation to Standard-of-Care Imaging', 'description': 'Paired t-test', 'timeFrame': '15 months'}, {'measure': 'Covariance of Whole Body MRI Cellularity Index (CI) and PET/CT Standardized Uptake Value (SUV)', 'description': 'For each identified lesion in the PET/CT, the lesion will be outlined, the size measured in millimeters, and the SUV will be calculated using the following equation:\n\nSUV= (decay-(corrected activity (kBq))/(tissue volume (ml) ))/(injected=(FDG activity (kBq))/(body weight (g) ))\n\nBaseline SUVs will also be calculated within normal appearing tissue.\n\nSimilarly, for each identified lesion in the whole-body RSI-MRI, the lesion will be outlined, the size measured as indicated above, and the CI will be calculated. Baseline CIs will also be calculated within normal appearing tissue.\n\nThe quantitative data will be analyzed for correlation across all lesions in all patients to determine the degree to which PET/CT SUV values and RSI-MRI CI values co-vary. Significance of the correlation coefficient, compared to zero correlation, will be assessed via the Student t-test, with alpha set to 0.05.', 'timeFrame': '15 months'}] | SecondaryOutcomes: N/A |
Title: Permanence of Indocyanine Green in Axillary Lymph Nodes 3 Weeks After Subdermal Injection in Patients With Braast Cancer and Metastatic Lymph Nodes (FLUO) | Condition: Breast Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Subdermal injection of 2,5 mg (1 cc) of ICG', 'type': 'EXPERIMENTAL', 'description': 'Subdermal injection of 2,5 mg (1 cc) of ICG will be performed 3 weeks before surgery', 'interventionNames': ['Drug: Indocyanine green']}] | Interventions:[{'type': 'DRUG', 'name': 'Indocyanine green', 'description': 'Subdermal injection of 2,5 mg (1 cc) of ICG', 'armGroupLabels': ['Subdermal injection of 2,5 mg (1 cc) of ICG']}] | PrimaryOutcomes: [{'measure': 'Permanence of fluorescence at the level of axillary lymph nodes at 2-3 weeks after subcutaneous injection of Indocyanine Green (2.5 mg), in patients who will undergo radical axillary surgery', 'description': 'Frequency of patient with at least 3 fluorescent lymph nodes', 'timeFrame': 'up to 3 weeks'}] | SecondaryOutcomes: [{'measure': 'Identification of the total number of fluorescent lymph nodes', 'description': 'Absolute frequency of total number of fluorescent lymph nodes per patient', 'timeFrame': 'up to 3 weeks'}, {'measure': 'Differences in the qualitative assessment (intensity) of fluorescence between the removed lymph nodes: lymph nodes will be divided into group A "intense fluorescence" and group B "mild fluorescence"', 'description': 'Absolute frequency of lymph nodes in group A and in group B', 'timeFrame': 'up to 3 weeks'}, {'measure': 'Association between histological positivity for metastases in sentinel and non-sentinel lymph nodes', 'description': 'Frequency of lymph nodes with metastases resulting fluorescent', 'timeFrame': 'up to 3 weeks'}, {'measure': "Association between the patient's demographic/clinical variables and the presence or absence of fluorescent lymph nodes", 'description': 'Frequency of fluorescent and non-fluorescent lymph nodes between subgroups of patients with different demographic and clinical characteristics', 'timeFrame': 'up to 3 weeks'}] |
Title: A Phase II, Multicenter, Open, Basket Study of AB-106 to Treat the Subjects With Local Progression or Systemic Metastasis Solid Tumors With NTRK Gene Fusion | Condition: Solid Tumor | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Single-arm trial whereby all consented, enrolled, eligible patients receive AB-106', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: AB-106']}] | Interventions:[{'type': 'DRUG', 'name': 'AB-106', 'description': '600mg QD for each subjects.', 'armGroupLabels': ['Single-arm trial whereby all consented, enrolled, eligible patients receive AB-106']}] | PrimaryOutcomes: [{'measure': 'Best overall response (BOR)', 'description': 'Assessed by Independent Review Committee (IRC) using RECIST v1.1', 'timeFrame': 'Approximately 24 months'}] | SecondaryOutcomes: [{'measure': 'Best overall response (BOR)', 'description': 'Assessed by Investigator using RECIST v1.1Investigator.', 'timeFrame': 'Approximately 24 months'}, {'measure': 'Duration of response (DOR)', 'description': 'Assessed by Independent Review Committee (IRC) and Investigator using RECIST v1.1', 'timeFrame': 'Approximately 24 months'}, {'measure': 'Time to Response (TTR)', 'description': 'Assessed by Independent Review Committee (IRC) and Investigator using RECIST v1.1', 'timeFrame': 'Approximately 24 months'}, {'measure': 'Time to Progress (TTP)', 'description': 'Assessed by Independent Review Committee (IRC) and Investigator using RECIST v1.1', 'timeFrame': 'Approximately 24 months'}, {'measure': 'Intracranial best overall response (IBOR)', 'description': 'Assessed by Independent Review Committee (IRC) and Investigator using RANO for subjects with intracranial metastasis at baseline.', 'timeFrame': 'Approximately 24 months'}, {'measure': 'Intracranial Duration of intracranial response (IDOR)', 'description': 'Assessed by Independent Review Committee (IRC) and Investigator using RANO for subjects with intracranial metastasis at baseline.', 'timeFrame': 'Approximately 24 months'}, {'measure': 'Progression free Survival (PFS)', 'description': 'Assessed by Independent Review Committee (IRC) and Investigator using RECIST v1.1', 'timeFrame': 'Approximately 30 months'}, {'measure': 'Overall survival (OS)', 'description': 'Assessed by Kaplan-Meier method', 'timeFrame': 'Approximately 36 months'}, {'measure': 'Adverse events (AE)', 'description': 'Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, graded by the NCI CTCAE 5.0', 'timeFrame': 'Approximately 36 months'}, {'measure': 'Plasma drug concentration (PK)', 'timeFrame': 'Approximately 60 days'}] |
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