Stage III Pancreatic Cancer Clinical Trial
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 Study
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.
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.
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