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Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44)

NCT02676349 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-03-27

No results posted yet for this study

Summary

This is a prospective, randomized phase II trial. The aim of this study is to assess the efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or without preoperative chemoradiotherapy with capecitabine.

Conditions

  • Pancreatic Carcinoma

Interventions

DRUG

mFolfirinox

oxaliplatin folinic acid irinotecan 5FU oxaliplatin

RADIATION

Chemoradiotherapy

conformational external irradiation (50.4 Gy) + capecitabine

PROCEDURE

surgery

1 to 4 weeks after neoadjuvant treatment according to tumour response

DRUG

Adjuvant chemotherapy

Gemcitabine or modified LV5FU (folinic acid+-bolus fluorouracil+ infusional fluorouracil)

Sponsors & Collaborators

  • Institut de Cancérologie de Lorraine

    lead OTHER

Principal Investigators

  • Thierry CONROY, Pr · Institut de Cancérologie de Lorraine

  • Jean-Baptiste BACHET, Pr · Groupe Hospitalier Pitié-Salpêtrière

  • Pascal HAMMEL, Pr · Hôpital Paul Brousse - Hôpitaux de Paris (AP-HP)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-10-13
Primary Completion
2024-04-19
Completion
2025-12-31

Countries

  • France

Study Locations

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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 NCT02676349 on ClinicalTrials.gov