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Study identifier: NCT06813976 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Ampullary Adenocarcinoma  ·  Sponsor: Centre Hospitalier Universitaire Dijon

PhasePhase 3
Planned participants294
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Gaël ROTH  ·  04 76 76 51 68  ·  groth@chu-grenoble.fr

Always discuss trial participation with your own doctor first.

Locations (1)

CHU Dijon BourgogneDijon, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT06813976