CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 147 enrolled
Drug / intervention
Fluorouracil +5 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/NCT02562716
NCT02562716Phase 2Completed

A Randomized Phase II Study of Perioperative mFOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma

SWOG Cancer Research Network·interventional·Posted Sep 29, 2015·Updated Oct 19, 2022

In Brief

A Phase 2 clinical trial evaluating Fluorouracil, Gemcitabine Hydrochloride, and 4 other interventions for Pancreatic Adenocarcinoma and Resectable Pancreatic Carcinoma. Completed, enrolled 147 participants across 807 sites.

Detailed Summary

This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and paclitaxel albumin-stabilized nanoparticle formulation, 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective than gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating pancreatic cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 29, 2015
Enrollment StartJan 6, 2016
Primary CompletionMay 31, 2020
Study CompletionSep 26, 2022
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 10.8 years ago

Interventions

Fluorouracildrug

Given IV

Gemcitabine Hydrochloridedrug

Given IV

Irinotecan Hydrochloridedrug

Given IV

Oxaliplatindrug

Given IV

Paclitaxel Albumin-Stabilized Nanoparticle Formulationdrug

Given IV

Pancreatectomyprocedure

Undergo pancreatectomy