Chemotherapy +/− Radiation before Surgery for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+154 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well combination chemotherapy (mFOLFIRINOX) with or without hypofractionated radiation therapy before surgery works in patients with pancreatic cancer that can be removed by surgery. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. It is not yet known if combination chemotherapy is more effective with or without hypofractionated radiation therapy before surgery in treating patients with pancreatic cancer.

Research Team

Matthew Katz, MD, FACS

Principal Investigator

The University of Texas MD Anderson Cancer Center

Eligibility Criteria

This trial is for patients with pancreatic cancer that can potentially be removed by surgery. They must not have had previous chemotherapy or radiation, no severe neuropathy, uncontrolled ulcers, or certain genetic conditions like Gilbert's syndrome. Participants need to have a good performance status and adequate organ function as indicated by blood tests.

Inclusion Criteria

I am not taking strong CYP3A4 inhibitors, or can stop them 14 days before the study.

Absolute neutrophil count (ANC) >= 1,500/mm^3

I haven't had severe stomach ulcers in the last month.

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Treatment Details

Interventions

Fluorouracil (Antimetabolites)
Hypofractionated Radiation Therapy (Radiation)
Irinotecan hydrochloride (Topoisomerase I inhibitors)
Oxaliplatin (Alkylating agents)

Trial OverviewThe study is testing how well combination chemotherapy (mFOLFIRINOX) works when given with or without hypofractionated radiation therapy before surgery. The goal is to see if the addition of this type of radiation therapy improves outcomes in treating pancreatic cancer.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: mFOLFIRINOX + surgery + FOLFOXExperimental Treatment3 Interventions

Patients receive 8 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.

Group II: mFOLFIRINOX + radiation + surgery + FOLFOXExperimental Treatment4 Interventions

Patients receive 7 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients receive radiation therapy then undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.

Fluorouracil is already approved in Canada for the following indications: