Clinical Trial: Chemotherapy and Radiation Therapy Before Surgery Followed by Gemcitabine in Treating Patients With Pancreatic Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Neoadjuvant FOLFIRINOX and Chemoradiation Followed by Definitive Surgery and Postoperative Gemcitabine for Patients With Borderline Resectable Pancreatic Adenocarcinoma: An Intergroup Single-Arm Pilot

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 Summary:

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.

Sponsor: Alliance for Clinical Trials in Oncology

Current Primary Outcome:

  • 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 [ Time Frame: Up to 3 years ]
  • Rate of treatment-related toxicity during preoperative therapy assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: Up to 30 days after completion of study treatment ]
  • Rate of treatment delay (greater than 4 weeks) during preoperative therapy [ Time Frame: Up to 28 weeks ]
  • Completion rate of all preoperative and operative therapy [ Time Frame: Up to 30 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Macroscopic (R0/R1) resection rate defined as number of patients achieved R0 or R1 resection during surgery divided by number of evaluable patients [ Time Frame: At the time of surgery ]
  • 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 [ Time Frame: Up to 18 weeks ]
  • 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 [ Time Frame: Up to 18 weeks ]
  • Time to locoregional recurrence [ Time Frame: From the date of registration to the date of the first documented locoregional recurrence, assessed up to 3 years ]
  • Time to distant recurrence [ Time Frame: From the date of registration to the date of the first documented distant recurrence, assessed up to 3 years ]
  • Overall survival [ Time Frame: From the date of registration to the date of the death due to all causes, assessed up to 3 years ]


Original Secondary Outcome: Same as current

Information By: Alliance for Clinical Trials in Oncology

Dates:
Date Received: March 25, 2013
Date Started: May 2013
Date Completion:
Last Updated: June 17, 2016
Last Verified: June 2016