Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06813976

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

Led by Centre Hospitalier Universitaire Dijon · Updated on 2025-07-11

294

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically proven adenocarcinoma on surgical specimen
  • Complete surgical removal of ampullary adenocarcinoma (R0 or R1)
  • Surgery performed within 12 weeks before enrollment
  • Age 18 years or older
  • No metastatic disease on CT scan within 4 weeks before enrollment
  • WHO performance status 0 or 1 (0 if over 75 years old)
  • Normal potassium, magnesium, and calcium levels
  • Ability to understand and sign informed consent
  • Use of effective contraception during treatment and up to 6 months after (9 months after oxaliplatin for women of childbearing potential)
  • Affiliation to a social security scheme in France or equivalent in Europe
  • CA19.9 level below 180 U/L at inclusion (post-operative)
Not Eligible

You will not qualify if you...

  • Prior neoadjuvant systemic chemotherapy
  • Tumors classified as pT1N0M0
  • Active infection with HBV, HCV, or HIV
  • Dihydropyrimidine dehydrogenase deficiency (uracilemia ≥ 16 ng/mL)
  • Pre-existing peripheral neuropathy grade 2 or higher
  • Uncontrolled medical conditions
  • Low blood counts: neutrophils < 1500/mm3, platelets < 150,000/mm3, hemoglobin < 9 g/dL
  • Total bilirubin above 1.5 times normal
  • Creatinine clearance below 50 ml/min
  • Liver enzymes (AST, ALT) or alkaline phosphatase elevated more than 2.5 times normal at least 15 days after surgery
  • Poor nutritional status (albumin < 30.0 g/dl)
  • Recent heart attack within 6 months, severe heart disease
  • Active or severe infection
  • Treatment with strong cytochrome P450 inhibitors or St John's Wort within 4 weeks before treatment
  • Use of brivudine within 4 weeks before treatment
  • Prolonged QT/QTc interval on ECG
  • Allergic reaction to study drugs
  • Live vaccines within 28 days before randomization
  • Other cancers treated within 5 years except certain skin and cervical cancers
  • Chronic bowel disease needing treatment or intestinal obstruction
  • Pregnant or breastfeeding women
  • Under legal guardianship
  • Unable to comply with medical follow-up due to social, psychological, or geographic reasons

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Dijon Bourgogne

Dijon, France, 21000

Actively Recruiting

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Research Team

G

Gaël ROTH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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