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COMPLETED
NCT01591733
PHASE2

FOLFIRINOX + RT for Pancreatic Cancer

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of a therapy to learn whether the therapy works in treating a specific cancer. "Investigational" means that the therapy is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if therapy is effective for treating different types of cancer. Proton beam radiation therapy is an FDA (U.S. Food and Drug Administration) approved radiation delivery system. Proton beam radiation therapy is known to spare surrounding normal tissues from radiation as it delivers less radiation beyond the area of the target tissues. This may reduce side effects that patients would normally experience with standard (photon) radiation therapy, which tends to include more normal tissue along with tumor target tissue. Researchers in the laboratory have discovered that there are pathways inside the cells that can lead to growth and survival of the tumor. The chemotherapy drugs FOLFIRINOX and capecitabine are targeted towards blocking the pathways that allow cancer cells to divide, and may result in the tumor shrinking in size. In this research study, the investigators are looking to determine if proton beam radiation in combination with FOLFIRINOX and capecitabine is effective in controlling the growth of your cancer.

Official title: Phase II Study of Preoperative FOLFIRINOX Followed by Accelerated Short Course Radiation Therapy for Borderline-Resectable Pancreatic Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2012-08-02

Completion Date

2021-04-15

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

DRUG

FOLFIRINOX

Up to Eight-14 day cycles

DRUG

Capecitabine

Orally, for 10 days

RADIATION

Short Course Radiation

Five or ten days

PROCEDURE

Surgery

1-4 weeks after completion of capecitabine therapy

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States