Chemotherapy and Radiation Therapy Before Surgery Followed by Gemcitabine in Treating Patients with Pancreatic Cancer
- Conditions
- Acinar Cell Adenocarcinoma of the PancreasDuct Cell Adenocarcinoma of the PancreasRecurrent Pancreatic CancerStage II Pancreatic CancerStage III Pancreatic Cancer
- Interventions
- Radiation: radiationProcedure: surgery
- Registration Number
- NCT01821612
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
This pilot clinical trial studies combination chemotherapy and radiation therapy before surgery followed by gemcitabine hydrochloride in treating patients with pancreatic cancer. Drugs used in chemotherapy, such as oxaliplatin, irinotecan hydrochloride, leucovorin calcium, fluorouracil, and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
- Detailed Description
The purpose of this study is to evaluate a new treatment program for patients with borderline resectable pancreas cancer in order to determine what effects, good and bad, chemotherapy and chemoradiation have on your cancer and to see if it allows safe surgery.
Primary Objectives:
* To assess the accrual rate of this study.
* To assess the rate of treatment-related toxicity and treatment delay during preoperative therapy.
* To assess the rate of completion of all preoperative and operative therapy.
Secondary Objectives:
* To assess the macroscopic (R0/R1) resection rate.
* To estimate the rate of radiographic and histopathologic response to preoperative therapy.
* To estimate the time to locoregional and distant recurrence.
* To assess overall survival (OS).
* To retrieve nucleic acids from pretreatment pancreatic ductal adenocarcinoma biopsies and to assess the quality of these nucleic acids using a sequencing-based assessment of tumor DNA.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description mFOLFIRINOX, chemoradiation, surgery and gemcitabine radiation Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m\^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m\^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m\^2 IV over 46-48 hours). Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m\^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same. Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle. mFOLFIRINOX, chemoradiation, surgery and gemcitabine surgery Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m\^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m\^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m\^2 IV over 46-48 hours). Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m\^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same. Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle. mFOLFIRINOX, chemoradiation, surgery and gemcitabine gemcitabine Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m\^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m\^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m\^2 IV over 46-48 hours). Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m\^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same. Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle. mFOLFIRINOX, chemoradiation, surgery and gemcitabine oxaliplatin Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m\^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m\^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m\^2 IV over 46-48 hours). Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m\^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same. Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle. mFOLFIRINOX, chemoradiation, surgery and gemcitabine leucovorin Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m\^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m\^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m\^2 IV over 46-48 hours). Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m\^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same. Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle. mFOLFIRINOX, chemoradiation, surgery and gemcitabine irinotecan Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m\^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m\^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m\^2 IV over 46-48 hours). Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m\^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same. Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle. mFOLFIRINOX, chemoradiation, surgery and gemcitabine 5-fluorouracil Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m\^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m\^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m\^2 IV over 46-48 hours). Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m\^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same. Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle. mFOLFIRINOX, chemoradiation, surgery and gemcitabine capecitabine Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m\^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m\^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m\^2 IV over 46-48 hours). Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m\^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same. Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle.
- Primary Outcome Measures
Name Time Method Completion rate of all preoperative and operative therapy Up to 30 weeks Accrual rate, calculated by total number of patients accrued divided by number of months from the date the study is opened at the fifth site to the evaluation date Up to 3 years Rate of treatment-related toxicity during preoperative therapy assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4 Up to 30 days after completion of study treatment Rate of treatment delay (greater than 4 weeks) during preoperative therapy Up to 28 weeks
- Secondary Outcome Measures
Name Time Method Macroscopic (R0/R1) resection rate defined as number of patients achieved R0 or R1 resection during surgery divided by number of evaluable patients At the time of surgery Histopathologic response rate defined as number of patients who achieved CR or PR determined according to histopathologic examination during pre-operative therapy divided by the number of evaluable patients Up to 18 weeks Time to locoregional recurrence From the date of registration to the date of the first documented locoregional recurrence, assessed up to 3 years Time to distant recurrence From the date of registration to the date of the first documented distant recurrence, assessed up to 3 years Radiographic response rate defined as number of patients who achieved complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 during pre-operative therapy divided by the number of evaluable patients Up to 18 weeks Overall survival From the date of registration to the date of the death due to all causes, assessed up to 3 years
Trial Locations
- Locations (14)
University of Chicago Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
🇺🇸Baltimore, Maryland, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
NorthShore University HealthSystem-Evanston Hospital
🇺🇸Evanston, Illinois, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University Pointe
🇺🇸West Chester, Ohio, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
The James Graham Brown Cancer Center at University of Louisville
🇺🇸Louisville, Kentucky, United States
Ochsner Medical Center Jefferson
🇺🇸New Orleans, Louisiana, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States