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

> **NCT06813976** · PHASE3 · RECRUITING · sponsor: **Centre Hospitalier Universitaire Dijon** · enrollment: 294 (estimated)

## Conditions studied

- Ampullary Adenocarcinoma

## Interventions

- **DRUG:** mFOLFORINOX
- **DRUG:** Capecitabine or gemcitabine
- **OTHER:** Quality of life questionnaires: QLQ-C30 and PAN26
- **BIOLOGICAL:** Biological assessment
- **DIAGNOSTIC_TEST:** Paraclinical examinations

## Key facts

- **NCT ID:** NCT06813976
- **Lead sponsor:** Centre Hospitalier Universitaire Dijon
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-07-02
- **Primary completion:** 2033-07
- **Final completion:** 2033-07
- **Target enrollment:** 294 (ESTIMATED)
- **Last updated:** 2025-07-11


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06813976

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06813976, "PRODIGE 98 : Randomized, Multicenter Phase 3 Trial of Adjuvant Chemotherapy With Modified FOLFIRINOX Versus Capecitabine or Gemcitabine in Patients With Resected Ampullary Adenocarcinoma". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT06813976. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*