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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DIJON · Feb 6, 2025

Keywords

ClinConnect Summary

The PRODIGE 98 trial is a research study looking at the effectiveness of two different chemotherapy treatments for patients who have had surgery for a rare type of cancer called ampullary adenocarcinoma. This cancer affects a small area of the digestive system, and while surgery can often remove it, some patients may still face a risk of the cancer returning. The trial is comparing a new treatment called modified FOLFIRINOX, which includes three types of chemotherapy combined with a vitamin, to standard treatments that use only one type of chemotherapy, either capecitabine or gemcitabine.

To participate in this trial, patients must be at least 18 years old and have had their cancer completely removed through surgery within the last three months. They also need to be in good overall health and free from other serious medical conditions. During the trial, participants will receive one of the two treatments and will be monitored closely by healthcare professionals. This study is not yet recruiting participants, but it offers hope for better treatment options for those affected by this challenging cancer.

Gender

ALL

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