NCT06813976 PRODIGE 98 : Randomized, Multicenter Phase 3 Trial of Adjuvant Chemotherapy With Modified FOLFIRINOX Versus Capecitabine or Gemcitabine in Patients With Resected Ampullary Adenocarcinoma
| NCT ID | NCT06813976 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Hospitalier Universitaire Dijon |
| Condition | Ampullary Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 294 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2033-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 294 participants in total. It began in 2025-07-02 with a primary completion date of 2033-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06813976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ampullary Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06813976 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 294 participants.
Is NCT06813976 currently recruiting?
Yes, NCT06813976 is actively recruiting participants. Contact the research team at groth@chu-grenoble.fr for enrollment information.
Where is the NCT06813976 trial being conducted?
This trial is being conducted at Dijon, France.
Who is sponsoring the NCT06813976 clinical trial?
NCT06813976 is sponsored by Centre Hospitalier Universitaire Dijon. The trial plans to enroll 294 participants.