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Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma

NCT01526135 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 493

Last updated 2022-01-04

No results posted yet for this study

Summary

This is a multicentric randomized phase III trial comparing adjuvant chemotherapy with gemcitabine versus 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (mFolfirinox) in patients with resected pancreatic adenocarcinoma.

Conditions

  • Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)

Interventions

DRUG

mFolfirinox

mFolfirinox every 14 days, 12 cycles, 24 weeks. mFolfirinox : Oxaliplatin (Eloxatin®) 85 mg/m² D1 over 2 hours, followed by Irinotecan (Campto®) 150 mg/m² D1 over 90 minutes to begin 30 min. after the Folinic acid infusion is started. Folinic acid 400 mg/m² (racemic mixture) (or 200 mg/m² if L-folinic acid is used), IV infusion over 2 hours. 5-FU 2.4 g/m² IV continuous infusion over 46 hours (1200 mg/m²/ day)

DRUG

Gemcitabine

Gemcitabine 1000 mg/m² IV infusion over 30 minutes, weekly, during 3 weeks + 1 week of rest (= 1 cycle) repeated 6 times (i.e., 6 cycles) during 24 weeks

Sponsors & Collaborators

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • UNICANCER

    lead OTHER

Principal Investigators

  • Thierry CONROY, PROF · Centre Alexis Vautrin-VANDOEUVRE LES NANCY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-16
Primary Completion
2018-03-31
Completion
2021-07-16

Countries

  • Canada
  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01526135 on ClinicalTrials.gov