Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma
Condition: Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicentric randomized phase III trial comparing adjuvant chemotherapy with
      gemcitabine versus 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (mFolfirinox) in
      patients with resected pancreatic adenocarcinoma.
    

Detailed description: 
      STUDY DESIGN/ Evaluation criteria Main criterion: efficacy The main criterion is the
      disease-free survival at 3 years. Disease-free survival is the time delay between the date of
      randomization and the date at which the 1st cancer-related event such as local relapse,
      distant metastasis, a second cancer or death from any cause is observed. Patients without
      event at the time of anlaysis will be censored at the date of last follow-up visit.

      Locoregional relapse is a disease relapse occurring at the site of primary resection, in the
      pancreas or in the associated regional lymph nodes.

      Metastatic relapse is the distant disease recurrence involving any possible sites of relapse
      (peritoneal, hepatic, pulmonary, and distant lymph nodes).

      Secondary criteria Overall and specific survival Overall survival is the time delay between
      the date of randomization and the patient's death, irrespective of its cause. Patients who
      are still living at the time of analysis will be censored at the date of last follow-up
      visit.

      Specific survival is the time delay between the date of randomization and the patient's death
      due to the treated cancer or a treatment-related complication.

      Metastasis-free survival Metastasis-free survival is the time delay between the date of
      randomization and the date of the 1st distant event occurrence (peritoneal, hepatic,
      pulmonary, and lymph nodes). Loco-regional events will be discarded and patients still living
      without metastasis at the time of analysis will be censored at the date of last follow-up
      examination objectively assessing this type of event.

      Tolerance Patients evaluable for toxicity must have received at least one course or injection
      of the treatment.
    

Intervention name(s): mFolfirinox; Gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): mFolfirinox every 14 days, 12 cycles, 24 weeks.
mFolfirinox : Oxaliplatin (Eloxatin®) 85 mg/m² D1 over 2 hours, followed by Irinotecan (Campto®) 150 mg/m² D1 over 90 minutes to begin 30 min. after the Folinic acid infusion is started.
Folinic acid 400 mg/m² (racemic mixture) (or 200 mg/m² if L-folinic acid is used), IV infusion over 2 hours.
5-FU 2.4 g/m² IV continuous infusion over 46 hours (1200 mg/m²/ day); Gemcitabine 1000 mg/m² IV infusion over 30 minutes, weekly, during 3 weeks + 1 week of rest (= 1 cycle) repeated 6 times (i.e., 6 cycles) during 24 weeks
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: National multicentric phase III superiority trial