CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 48 enrolled
Drug / intervention
FOLFIRINOX +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01591733
NCT01591733Phase 2Unknown

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

Massachusetts General Hospital·interventional·Posted May 4, 2012·Updated May 28, 2021

In Brief

A Phase 2 clinical trial evaluating FOLFIRINOX, Capecitabine, and 2 other interventions for Pancreatic Cancer. Targeting 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2UnknownOverdue
201220132014201520162017201820192020202120222023202420252026
First PostedMay 4, 2012
Enrollment StartMay 1, 2012
Primary CompletionMar 1, 2017
Study CompletionJan 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.2 years ago

Interventions

FOLFIRINOXdrug

Up to Eight-14 day cycles

Capecitabinedrug

Orally, for 10 days

Short Course Radiationradiation

Five or ten days

Surgeryprocedure

1-4 weeks after completion of capecitabine therapy