CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 27 enrolled
Drug / intervention
Oxaliplatin +4 moredrug
Likely dose
Oxaliplatin 85 mgfrom 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/NCT01926197
NCT01926197Phase 3Completed
CompareCT.gov

A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) With or Without Stereotactic Body Radiotherapy (SBRT) in the Treatment of Locally Advanced Pancreatic Cancer: A Pancreatic Cancer Radiotherapy Study Group (PanCRS) Trial

Stanford University·interventional·Posted Aug 20, 2013·Updated Oct 28, 2022

In Brief

A Phase 3 clinical trial evaluating Oxaliplatin, Irinotecan, and 3 other interventions for Pancreatic Cancer. Completed, enrolled 27 participants across 9 sites in 2 countries.

Detailed Summary

The goal of this study is to determine the safety and efficacy of a chemotherapy regimen known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body Radiotherapy (SBRT). We hope to learn if this new treatment combination helps to control the disease and improve survival for patients with locally advanced pancreatic cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 20, 2013
Enrollment StartAug 14, 2013
Primary CompletionSep 30, 2021
Study CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 12.9 years ago

Interventions

Oxaliplatindrug

Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.

Irinotecandrug

Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.

Leucovorindrug

Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.

5FUdrug

5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.

Stereotactic Body Radiotherapy (SBRT)radiation

Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.