NCT01821612

Chemotherapy and Radiation Therapy Before Surgery Followed by Gemcitabine in Treating Patients with Pancreatic Cancer

Neoadjuvant FOLFIRINOX and Chemoradiation Followed by Definitive Surgery and Postoperative Gemcitabine for Patients with Borderline Resectable Pancreatic Adenocarcinoma: an Intergroup Single-Arm Pilot Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acinar Cell Adenocarcinoma of the Pancreas
• Duct Cell Adenocarcinoma of the Pancreas
• Recurrent Pancreatic Cancer
• Stage II Pancreatic Cancer
• Stage III Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	oxaliplatin	IV
DRUG	irinotecan	IV
DRUG	leucovorin	IV
DRUG	5-fluorouracil	IV
DRUG	capecitabine	PO
RADIATION	radiation
PROCEDURE	surgery
DRUG	gemcitabine	IV

Timeline

• Start date: 2013-05-29
• Primary completion: 2014-11-01
• Completion: 2018-06-15
• First posted: 2013-04-01
• Last updated: 2025-01-13

Locations

14 sites across 1 country: United States