This is a prospective, randomized phase II trial. The aim of this study is to assess the efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or without preoperative chemoradiotherapy with capecitabine.
Surgery, especially if followed by adjuvant chemotherapy, offers the only chance of cure of pancreatic cancer. At first diagnosis, after careful assessment, only 10 to 15% of patients are considered to be candidates for surgical resection and about 7% have a potentially resectable disease. These potentially resectable tumors called "borderline resectable pancreatic cancer" (BRPC) are conceptualized as those that involve the mesenteric vasculature to a limited extent and those for which resection, while possible, would likely be compromised by positive surgical margins (R1) in the absence of neoadjuvant treatment. R0 resection is indeed considered as an independent prognostic factor for survival when the surgical procedures, histological examination and definition of microscopic invasion are standardized. The objectives of neoadjuvant treatments of BRPC is to reduce tumor volume before surgery in order to improve the chances of radical (R0) resection and to reduce the rate of lymph node positivity and recurrences. The primary outcome in published studies is usually R0 resection rate, but these results also depend on the number of margins examined and the definition of microscopic margin involvement. Prospective studies with consistent selection criteria and standardized assessment criteria are needed. Different neoadjuvant therapeutic strategies have been tested in pilot studies: preoperative chemoradiotherapy or neoadjuvant chemotherapy, followed or not by a preoperative (chemo)radiotherapy. Due to the lack of randomized studies, the best sequence of treatment administration has not been established. The aim of this prospective, randomized, multicenter, trial is to evaluate the R0 resection rate with neoadjuvant Folfirinox, followed or not by radiochemotherapy for patients with borderline resectable pancreatic cancers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
oxaliplatin folinic acid irinotecan 5FU oxaliplatin
conformational external irradiation (50.4 Gy) + capecitabine
1 to 4 weeks after neoadjuvant treatment according to tumour response
Institut Bergonié
Bordeaux, France
Polyclinique Bordeaux Nord
Bordeaux, France
To assess the efficacy of two neoadjuvant therapies in patients with borderline resectable pancreatic carcinoma evaluated on histological R0 resection margin rate
Time frame: up to 7.5 months
Evaluate the toxicities associated with chemotherapy and chemoradiotherapy
Time frame: up to 7 years
Evaluate the proportion of resected patients
Time frame: up to 7.5 months
Evaluate the response rate to chemotherapy and chemoradiotherapy
Time frame: up to 7.5 months
Evaluate the histological complete response rate in resected patients.
Time frame: up to 7.5 months
Evaluate the perioperative mortality rate
Time frame: up to 8.5 months
Evaluate the perioperative morbidity rate
Time frame: up to 8.5 months
Evaluate the overall survival
Time frame: up to 7 years
Evaluate the quality of life
Time frame: up to 7.5 months
Evaluate the loco-regional relapse-free survival
Time frame: 7 years
Evaluate the metastatic Progression Free Survival
Time frame: 7 years
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Masking
NONE
Enrollment
130
Gemcitabine or modified LV5FU (folinic acid+-bolus fluorouracil+ infusional fluorouracil)
Hôpital Beaujon
Clichy, France
Chu Colmar
Colmar, France
Hôpital Henri Mondor (APHP)
Créteil, France
Centre Oscar Lambret
Lille, France
Chru Lille
Lille, France
Infirmerie Protestante de Lyon
Lyon, France
Hôpital Européen Marseille
Marseille, France
Hôpital La Timone
Marseille, France
...and 16 more locations
Evaluate the progression-free survival
Time frame: 7 years