CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 126 enrolled
Drug / intervention
mFOLFIRINOX +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/NCT02839343
NCT02839343Phase 2Unknown

Preoperative Extended Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas

Alliance for Clinical Trials in Oncology·interventional·Posted Jul 20, 2016·Updated May 24, 2022

In Brief

A Phase 2 clinical trial evaluating radiation therapy, surgery, and 2 other interventions for Pancreatic Adenocarcinoma and Borderline Resectable Adenocarcinoma of the Head of the Pancrease. Targeting 126 participants across 155 sites in 2 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 2UnknownOverdue
2017201820192020202120222023202420252026
First PostedJul 20, 2016
Enrollment StartDec 1, 2016
Primary CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 10.0 years ago

Interventions

radiation therapyradiation

surgeryprocedure

mFOLFIRINOXdrug

oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV

FOLFOXdrug

oxaliplatin IV, leucovorin IV and 5-FU IV