Multicentric Randomized Phase III Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) in Patients With Resected Pancreatic Adenocarcinoma
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
disease-free survival (DFS)
to compare disease-free survival (DFS) at 3 years between the experimental and control arms.
Thierry CONROY, PROF
Centre Alexis Vautrin-VANDOEUVRE LES NANCY