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

ConditionAmpullary Adenocarcinoma

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorCentre Hospitalier Universitaire Dijon

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven adenocarcinoma on surgical specimen

Macroscopically complete surgical resection of an ampullary adenocarcinoma (R0 or R1)

Adenocarcinoma removed within 12 weeks prior to enrollment

Patients ≥ 18 years of age

Disqualifiers

Neoadjuvant systemic chemotherapy

pT1N0M0 tumors

Active infection by HBV, HCV or HIV

Dihydropyrimidine dehydrogenase deficiency (uracilemia ≥ 16 ng/mL)

Trial design

Design model

Parallel

Treatments tested in this trial

mFOLFORINOX
Drug
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
Capecitabine or gemcitabine
Drug
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)
Quality of life questionnaires: QLQ-C30 and PAN26
Other intervention
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)
Biological assessment
Biological/Vaccine
Before each course of treatment and between courses of treatment if necessary
Paraclinical examinations
Diagnostic test
Every 3 months

Treatment groups

294 Participants

are divided into 2 treatment groups

Group A: Experimental strategyExperimental treatment 4 interventions

Group B: Standard treatmentsActive comparator 4 interventions

Trial outcomes

Primary outcomes

Disease-free survival (DFS)

To compare DFS between the 2 arms of treatments in randomized patients

Time frame

Assessed up to 36 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire Dijon

Lead sponsor

Source ClinicalTrials.gov

Apply now