Adjuvant mFOLFIRINOX versus capecitabine or gemcitabine for resected ampullary adenocarcinoma
PRODIGE 98 : Randomized, Multicenter Phase 3 Trial of Adjuvant Chemotherapy With Modified FOLFIRINOX Versus Capecitabine or Gemcitabine in Patients With Resected Ampullary Adenocarcinoma
This trial will test whether giving modified FOLFIRINOX after surgery lowers the chance of cancer returning compared with capecitabine or gemcitabine in adults with resected ampullary adenocarcinoma.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 294 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Dijon) |
| Trial ID | NCT06813976 on ClinicalTrials.gov |
What this trial studies
This is a randomized, multicenter Phase 3 trial comparing adjuvant modified FOLFIRINOX (oxaliplatin, irinotecan, 5-fluorouracil with folinic acid) to standard single-agent adjuvant chemotherapy (capecitabine or gemcitabine) in patients who have had complete surgical resection of ampullary adenocarcinoma. Eligible patients are adults with histologically confirmed disease, no metastatic disease on recent imaging, and adequate performance status and laboratory values, randomized within 12 weeks of surgery. Treatments are administered per protocol with regular clinical and paraclinical monitoring, biological assessments, and quality-of-life questionnaires (QLQ-C30 and PAN26). The trial measures recurrence and survival outcomes along with safety and patient-reported quality of life.
Who should consider this trial
Good fit: Adults (≥18) with histologically proven ampullary adenocarcinoma who had macroscopically complete resection (R0 or R1) within 12 weeks, no metastatic disease on recent CT, WHO performance status 0–1, and adequate labs and contraception as required are ideal candidates.
Not a fit: Patients with metastatic disease, poor performance status (WHO >1), significant comorbidities that preclude multi-agent chemotherapy, or inability to tolerate intensified regimens are unlikely to benefit from the experimental arm.
Why it matters
Potential benefit: If successful, this regimen could reduce recurrence and improve survival compared with current single-agent adjuvant options.
How similar studies have performed: Modified FOLFIRINOX showed clear benefit as adjuvant therapy in pancreatic cancer trials, but its efficacy specifically for ampullary adenocarcinoma remains unproven and is being tested here.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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 this trial is running
Dijon
- CHU Dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Gaël ROTH
- Email: groth@chu-grenoble.fr
- Phone: 04 76 76 51 68
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.