PC is an aggressive malignancy and the 4th cause of all cancer deaths worldwide. More than 30% of patients with PC are unresectable because of the local extension with a median overall survival (OS) of less than one year. The standard of care remains gemcitabine (gem) alone. 5FU, irinotecan, oxaliplatin (Folfirinox) is superior to gemcitabine in the treatment of metastatic PC, in terms of OS and progression-free survival (PFS).
This phase 3, multicenter randomised study (NCT02539537) was designed to evaluate the efficacy of FOLFIRINOX versus gem in the treatment of locally advanced PC (LAPC). This study enrols patients > 18 year of age, with cytologically or pathologically proven adenocarcinoma of the pancreas, who had a LAPC proven to be unresectable after multidisciplinary discussion, a performance status ECOG < 2, normal hematologic, hepatic, and renal functions, adequate other vital functions; the tumour has to be measurable (RECIST criteria) and the patient has to give his informed consent. The primary endpoint of this study is PFS; secondary endpoints include a composite index for induction treatment severe toxicity: biliary tract infection Grade3-4 + any grade 5 toxicities + induction chemotherapy interruption for toxicity, OS, time to treatment failure, quality of life, percentage of surgery with curative intent. Treatment regimens is: Arm A: gem 1000 mg/m² 30-minute infusion, weekly for 7 weeks followed by one week rest and then weekly for 3 weeks followed by one week. Arm B: leucovorin 400 mg/m² D1, irinotecan 180 mg / m² D1, Oxaliplatin 85 mg / m² D1, 5 Fluorouracil 2400 mg/m² IV continuous infusion over 46 h (no bolus of 5FU), treatment repeated every two weeks for 4 months (12 cycles). Duration of treatment: 6 months in both arms. After this 6-month period, each center has to choose for its patients between 3 strategies: stop of treatment, maintenance chemotherapy with gem or capecitabine and radio-chemotherapy. At this time 74 among the 170 planned patients have been enrolled. The first IDMC meeting has recommended continuing the study without any change.
Clinical trial identification
Legal entity responsible for the study
French Program for Cancer Clinical research (PHRC).
M.P. Ducreux: Wife employee: Sandoz. P. Follana: Advisory board, board of directors, consultant board: AstraZeneca, Novartis, Tesaro. O. Bouche: Stock owner: Amgen, Bayer, Merck, Roche; Employment: Lilly, Pierre Fabre, Novartis. All other authors have declared no conflicts of interest.