RecruitingPhase 3NCT06813976

PRODIGE 98 : Randomized, Multicenter Phase 3 Trial of Adjuvant Chemotherapy With Modified FOLFIRINOX Versus Capecitabine or Gemcitabine in Patients With Resected Ampullary Adenocarcinoma

Sponsor

Centre Hospitalier Universitaire Dijon

Enrollment

294 participants

Start Date

Jul 2, 2025

Study Type

INTERVENTIONAL

Conditions

Ampullary Adenocarcinoma

Summary

Ampullary adenocarcinoma (AMPAC) is a rare cancer (0.2% of digestive cancers) affecting the ampulla of Vater. The only curative treatment is surgery, but around 4% of patients recur within 2 years of surgical resection. The aim of adjuvant chemotherapy is to reduce the risk of disease recurrence, and the only chemotherapies that can be considered standard to date are capecitabine and gemcitabine. In this trial, an alternative experimental treatment strategy using modified FOLFORINOX (mFOLFORINOX) is proposed. It consists of 3 chemotherapies with complementary actions: 5-fluorouracil, irinotecan and oxaliplatin, combined with folic acid a vitamin that enhances the efficacy of 5-fluorouracil. This study proposes 2 treatment schemes: * Group A: mFOLFIRINOX: oxaliplatin, irinotecan, 5-fluorouracil, with folinic acid, * group B: mono-chemotherapy with capecitabine or gemcitabine.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Biological assessment, a drug called Capecitabine or gemcitabine, and others for people with ampullary adenocarcinoma. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGmFOLFORINOX

mFOLFIRINOX every 2 weeks during 12 cycles (24 weeks): * Oxaliplatin 85 mg/m² * Irinotecan 150 mg/m² * Leucovorin 400 mg/m² * Fluorouracil 2400 mg/m² during 46 hours

DRUGCapecitabine or gemcitabine

investigator's choice: * Capecitabine 1250 mg/m² BID, 2 weeks on, 1 week off during 8 cycles (24 weeks) OR * Gemcitabine 1000 mg/m² in 30 min; 3 weeks on, 1 week of, during 6 cycles ((24 weeks)

OTHERQuality of life questionnaires: QLQ-C30 and PAN26

Before treatment, during treatment (every 12 weeks in any treatment arm Until disease progression or end of follow-up) and after treatment discontinuation (30 days after the end of treatment)

BIOLOGICALBiological assessment

Before each course of treatment and between courses of treatment if necessary

DIAGNOSTIC_TESTParaclinical examinations

Every 3 months