PRODIGE 98 : Randomized, Multicenter Phase 3 Trial of Adjuvant Chemotherapy With Modified FOLFIRI… (NCT06813976) | Clinical Trial Compass
RecruitingPhase 3
PRODIGE 98 : Randomized, Multicenter Phase 3 Trial of Adjuvant Chemotherapy With Modified FOLFIRINOX Versus Capecitabine or Gemcitabine in Patients With Resected Ampullary Adenocarcinoma
France294 participantsStarted 2025-07-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
* …