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

Recruiting now · Phase 3

Conditions studied: Ampullary Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT06813976

Run by

Centre Hospitalier Universitaire Dijon

People needed

294

Starts

2025-07-02

Expected to finish

2033-07-01

Last updated by the study team

2025-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Patient without metastatic disease on CT scan < 4 weeks prior to inclusion
• WHO performance status 0 or 1 (WHO 0 if age >75)
• Normal values of kalemia, magnesemia and calcemiaPatient able to understand and sign the information and informed consent note
• Women of childbearing age and men who are sexually active with women of childbearing age must agree to use highly effective contraception during the trial treatment at least until 6 months after the end of experimental treatment. Women of childbearing potential must use highly effective contraception at least 9 months after the end of treatment with oxaliplatin
• Patient affiliated to a social security scheme for France, or equivalents in European countries
• CA19.9 level < 180 U/L at inclusion (post-operative level)

You may not qualify if…

• Neoadjuvant systemic chemotherapy
• pT1N0M0 tumors
• Active infection by HBV, HCV or HIV
• Dihydropyrimidine dehydrogenase deficiency (uracilemia ≥ 16 ng/mL)
• Pre-existing peripheral neuropathy (grade ≥ 2)
• Unresolved or uncontrolled concomitant medical conditions
• Neutrophils < 1500/mm3, platelets < 150 000/mm3, Haemoglobin < 9 g/dL
• Total bilirubin > 1.5x normal,
• Creatinine clearance < 50 ml/min according to MDRD
• AST or ALT > 2.5 x UNL, alkaline phosphatase > 2.5x normal at least 15 days after resection
• Patients with poor nutritional status represented by albuminemia < 30.0g/dl
• History of myocardial infarction within the last 6 months, severe coronary artery disease or severe heart failure
• Active and/or potentially severe infection
• Treatment with a strong cytochrome P450 inhibitor within 4 weeks prior to the administration of the protocol treatment (Treatment with Hypericum perforatum)
• Patient under treatment by brivudine, or treated by brivudine within 4 weeks prior to beginning of study treatment
• Concomitant use with St John's Wort
• QT/QTc interval longer than 450msec for men and longer than 470msec for women on the ECG
• Hypersensitivity to any of the study products or their excipients
• Administration of live vaccines within 28 days prior to randomization
• Other cancer treated within the last 5 years except adequately treated, in situ cervical carcinoma or basocellular/spinocellular carcinoma
• chronic bowel disease requiring specific treatment and/or intestinal obstruction
• Pregnant or breastfeeding woman
• Person under guardianship
• Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons

Where it is running

• CHU Dijon Bourgogne — Dijon, France (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.