At a glance
ClinicalIndex Comparison Record- ✓Histologically proven adenocarcinoma on surgical specimen
- ✓Macroscopically complete surgical resection (R0 or R1)
- ✓Adenocarcinoma removed within 12 weeks prior to enrollment
- ✓Age ≥ 18 years
- ✕Neoadjuvant systemic chemotherapy
- ✕pT1N0M0 tumors
- ✕Active infection by HBV, HCV or HIV
- ✕Pre-existing peripheral neuropathy grade ≥ 2
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PRODIGE 98 : Randomized, Multicenter Phase 3 Trial of Adjuvant Chemotherapy With Modified FOLFIRINOX Versus Capecitabine or Gemcitabine in Patients With Resected Ampullary Adenocarcinoma
In Brief
A Phase 3 clinical trial evaluating mFOLFORINOX, Capecitabine or gemcitabine, and 3 other interventions for Ampullary Adenocarcinoma. Currently recruiting, targeting 294 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
mFOLFIRINOX every 2 weeks during 12 cycles (24 weeks): * Oxaliplatin 85 mg/m² * Irinotecan 150 mg/m² * Leucovorin 400 mg/m² * Fluorouracil 2400 mg/m² during 46 hours
investigator's choice: * Capecitabine 1250 mg/m² BID, 2 weeks on, 1 week off during 8 cycles (24 weeks) OR * Gemcitabine 1000 mg/m² in 30 min; 3 weeks on, 1 week of, during 6 cycles ((24 weeks)
Before treatment, during treatment (every 12 weeks in any treatment arm Until disease progression or end of follow-up) and after treatment discontinuation (30 days after the end of treatment)
Before each course of treatment and between courses of treatment if necessary
Every 3 months