Adjuvant mFOLFIRINOX versus capecitabine or gemcitabine for resected ampullary adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Dijon Bourgogne
  Dijon, France Recruiting

Study contacts

• Study coordinator: Gaël ROTH
• Email: groth@chu-grenoble.fr
• Phone: 04 76 76 51 68

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.