Clinical Trials Actively Recruiting

Objective:

Primary Objectives:

• To determine if overall survival (OS) is improved with proton beam therapy (PBT) treatment as compared to intensity modulated radiation therapy (IMRT) as part of planned protocol treatment for patients with esophageal cancer.
• To determine if OS with PBT is non-inferior to IMRT as part of planned protocol treatment and that there will be less grade 3+ cardiopulmonary toxicity with PBT than with IMRT.

Secondary Objectives:

• To compare the symptom burden and impact on functioning of patients between treatment modalities based on Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI) and PROMIS-Fatigue;
• To compare the Quality-Adjusted Life Years (QALY) using EQ5D as a health outcome (Kilbridge 2010) between PBT and IMRT, if the protocol primary endpoint is met;
• To assess the pathologic response rate between PBT and IMRT;
• To assess the cost-benefit economic analysis of treatment between radiation modalities;
• To compare the length of hospitalization after protocol surgery between PBT and IMRT;
• To compare the incidence of grade 4 lymphopenia during chemoradiation between PBT and IMRT;
• To compare lymphocyte nadir at first follow-up visit after completion of chemoradiation between PBT & IMRT;
• To estimate the locoregional failure, distant metastatic free survival, and progression-free survival of patients treated with PBT versus IMRT;
• To compare incidence of both early (< 90 days from treatment start) and late (≥ 90 days from treatment start) cardiovascular and pulmonary events between PBT versus IMRT;
• To compare the Total Toxicity Burden (TTB) of IMRT versus PBT based on a composite index of 9 individual cardiopulmonary toxicities.

Exploratory Objectives:

• To collect biospecimens for future analyses, for example to assess cardiac and inflammatory biomarkers in association with treatment complications.

Objective:

Primary Objective:

• To evaluate the progression free survival (PFS) of advanced pancreatic cancer patients with germline BRCA1 or BRCA2 mutations treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy.

Secondary Objectives:

• To evaluate the safety and tolerability associated with the combination of olaparib + pembrolizumab vs. olaparib alone as maintenance therapy.
• To evaluate the overall survival (OS) of patients treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy.
• To evaluate the overall response rate (ORR) by RECIST 1.1, including confirmed and unconfirmed, complete and partial response, of patients treated with olaparib + pembrolizumab compared to olaparib alone, in the subset of patients with measurable disease.
• To evaluate the overall response rate (ORR) by immune RECIST, including confirmed and unconfirmed, complete and partial response, of patients treated with olaparib + pembrolizumab compared to olaparib alone, in the subset of patients with measurable disease.
• To evaluate the duration of response (DoR) by RECIST 1.1 in patients treated with olaparib + pembrolizumab compared to olaparib alone.

Banking Objective:

• To bank tissue and blood specimens for future correlative studies.

Objective:

Primary Objective:

• To determine the efficacy, based on PFS, of mFOLFOX6/bevacizumab plus atezolizumab (combination) as compared to single agent atezolizumab.

Secondary Objectives:

• To compare the overall survival
• To compare the objective response rates (ORR) per RECIST 1.1
• To determine the safety profiles of single agent atezolizumab and the combination of mFOLFOX6 bevacizumab/atezolizumab in patients with dMMR/MSI-H mCRC
• To determine the duration of response
• To determine the duration of stable disease
• To evaluate the rate of progression-free survival at 12 months
• To evaluate the disease control rate (CR + PR + SD) at 12 months

Objective:

Primary Objective Phase II:

• To compare the rate of ctDNA clearance in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer.

Primary Objective Phase III:

• To compare recurrence-free survival (RFS) in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer.

Secondary Objectives:

• To describe the prevalence of detectable ctDNA in patients with stage IIA colon cancer following surgical resection.
• To estimate time-to-event outcomes (overall survival [OS], recurrence-free survival [RFS], and time to recurrence [TTR] by ctDNA marker status and treatment for patients with resected stage IIA colon cancer.
• To estimate the rate of compliance with adjuvant chemotherapy and/or active surveillance for patients with resected stage IIA colon cancer.

Objective:

Primary Objective:

• To determine whether de-intensified chemoradiation for early stage SCCA is able to maintain excellent 2year disease control of 85% or higher while improving anorectal HRQL, compared to standard-dose CRT, as measured by the change in the FIQoL instrument coping/behavior domain from baseline to 1 year.

Secondary Objectives:

• To compare changes in patient-reported outcomes (as per FISI, PROMIS, IIEF, SVQ, and VAS/VuAS instruments) between the experimental and control arm.
• To compare patterns of failure (local and regional relapse versus distant; infield versus out-of-field of radiation), disease control, and overall survival between experimental and control arm.
• To correlate vaginal dilator use during radiation delivery with sexual function.
• To measure changes in serum total testosterone from baseline to up to 12 months after radiation.
• To validate the utility of image features of inguinal and pelvic lymph nodes obtained prior to treatment as a prognostic indicator that can identify patients with early-stage anal squamous cell carcinoma for whom treatment with de-intensified chemo-radiation is appropriate.
• To determine whether an online, interactive educational tool (eContour) may improve the quality of radiation target delineation for anal cancer.
• To determine the incidence of and predictors for cardiovascular toxicity in patients receiving 5-FU or Capecitabine.

Objective:

Primary Endpoints:

• Overall survival.

Secondary Endpoints:

All secondary endpoints are exploratory and involve evaluating multiple dimensions of treatment, tolerance and clinical outcomes. As such and in order to maximize statistical power and precision, all secondary endpoint analyses will be done independently without any global type I error control.

• Progression-free survival.
• Objective tumor response.
• CGA/QOL related objectives:
  
  • We hypothesize that lower scores in functional status assessment tool – instrumental activities of daily living (IADL) will correlate with higher rates of grade 3 or higher chemotherapy toxicity.
• CGA/QOL related exploratory objectives:
  
  • Evaluation of other pre-treatment CGA domains including Co-morbidities, depression, nutrition and cognition as predictors of chemotherapy tolerance.
  • Evaluation of the association between change in functional status during treatment course (comparison between ADL and IADL scores pre-treatment and at time of disease evaluation) as predictors of chemotherapy tolerance.
  • Evaluation of the correlation between CGA domains and overall survival by treatment arm.
  • Evaluation of the difference in QOL scores (FACT-Hep Version 4) between baseline measures and assessment during treatment course between by treatment arms.
  • Focused evaluation of toxicities that are of interest for older patients including: peripheral neuropathy, fatigue, falls, emergency room visits, hospitalization, treatment modification and discontinuation.
• Imaging correlative study objectives:
  
  • Evaluate the association between baseline and change during treatment of skeletal muscle index (SMI) and intermuscular adipose tissue (IMAT) and rates of grade 3 or higher chemotherapy toxicity experienced on treatment.
  • Evaluate the association between baseline and change during treatment of skeletal muscle index (SMI) and intermuscular adipose tissue (IMAT) and overall survival among older patients with metastatic pancreatic cancer.
  • Evaluate the associate between baseline and change during treatment of skeletal muscle index (SMI) and intermuscular adipose tissue (IMAT) and geriatric assessment scores evaluating functional status.
• Laboratory correlative study objectives:
  
  • Evaluation of the correlation between base line levels of biomarkers of aging (CRP and IL-6) and rates of grade 3 or higher chemotherapy toxicity during therapy.
  • Evaluation of the correlation between changes in levels of CRP and IL-6 during therapy and rates of grade 3 chemotherapy toxicity.
  • Evaluation of the correlation between baseline levels of biomarkers of aging (CRP and IL-6) and overall survival among older patients with metastatic pancreatic cancer.
  • Evaluation of the correlation between levels of baseline biomarkers of aging (CRP and IL-6) and geriatric assessments scores evaluation functional status.

Objective:

Primary Objectives:

• To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved progression free survival (PFS) versus systemic chemotherapy alone.

Secondary Objectives:

• To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved overall survival (OS) versus systemic chemotherapy alone.
• To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved objective response using RECIST v1.1 versus systemic chemotherapy alone.
• To evaluate toxicity profiles of the two regimens.

Objective:

Primary Objective:

• To evaluate and compare overall survival (OS) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX

Secondary Objectives:

• To evaluate and compare disease-free survival (DFS) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
• To evaluate and compare time to locoregional recurrence (TLR) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
• To evaluate and compare time to distant metastases (TDM) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
• To evaluate and compare the R0 resection rate in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
• To evaluate and compare rate of unresectability in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
• To evaluate rate of pathologic complete response in patients randomized to the perioperative therapy arm
• To evaluate and compare mFOLFIRINOX dose intensity delivered and number of cycles received in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
• To evaluate and compare adverse event profile in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
• To compare physical functioning, nausea/vomiting, and diarrhea, as measured with the EORTC QLQ-C30 between patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
• To prospectively assess the influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the disease-free survival and overall survival among patients with localized pancreatic cancers
• To assess the influence of diet, obesity, physical activity, and other lifestyle habits on the risk of toxicity associated with chemotherapy
• To evaluate the ability of CT-based radiomics in distinguishing post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor in patients randomized to the perioperative therapy arm
• To determine whether CT-based radiomics retrieved from baseline examination may act as non-invasive predictors of survival outcome in patients randomized to the adjuvant therapy arm

Objective:

Primary Objective:

• To determine whether atezolizumab combined with FOLFOX and its continuation as monotherapy can significantly improve DFS compared to FOLFOX alone in patients with stage III colon cancers and dMMR.

Secondary Objectives:

• To determine whether atezolizumab combined with FOLFOX and its continuation as monotherapy can significantly improve overall survival compared to FOLFOX alone in patients with stage III colon cancers and dMMR.
• To assess the adverse events (AE) profile and safety of each treatment arm, using the CTCAE and PRO-CTCAE

Objective:
Primary Objectives:

• To determine whether cabozantinib can significantly improve progression-free survival (PFS) compared to placebo in patients with advanced pancreatic NET whose disease has progressed after treatment with everolimus.
• To determine whether cabozantinib can significantly improve progression-free survival (PFS) compared to placebo in patients with advanced carcinoid tumors whose disease has progressed after treatment with everolimus.

Secondary Objectives:

• To determine whether cabozantinib can significantly improve overall survival (OS) compared to placebo in patients with advanced pancreatic NET whose disease has progressed after treatment with everolimus.
• To determine whether cabozantinib can significantly improve overall survival (OS) compared to placebo in patients with advanced carcinoid tumors whose disease has progressed after treatment with everolimus.
• To evaluate safety and tolerability of cabozantinib versus placebo in patients with advanced pancreatic NET using CTCAE and PRO-CTCAE.
• To evaluate safety and tolerability of cabozantinib versus placebo in patients with advanced carcinoid tumors using CTCAE and PRO-CTCAE.
• To evaluate the overall radiographic response rate of cabozantinib versus placebo in patients with advanced pancreatic NET whose disease has progressed after treatment with everolimus.
• To evaluate the overall radiographic response rate of cabozantinib versus placebo in patients with advanced carcinoid tumors whose disease has progressed after treatment with everolimus.