A prospective, opened, multicentric, randomised, phase III trial with two arms: * Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin * Arm B: curative gastrectomy with D1-D2 lymph node dissection Main objective: Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology), treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
367
After the D2 resection is complete HIPEC can start. A roller pump forces the chemotherapy solution (oxaliplatin 250 mg/m² with 2 Liters of G5%/m²) into the abdomen through the inflow catheter and pulls it out through the drains. A heat exchanger keeps the intraperitoneal fluid at 42°-43°C.
All the patients will undergo a D1-D2 gastrectomy carried out according to Japanese guidelines and to the European recommendations for the preservation of spleen and pancreas
Overall survival
From the date of surgery to the date of death or to the end of follow-up
Time frame: 5 years
Recurrence-free survival
From the date of surgery to the date of recurrence or to the end of follow-up
Time frame: 5 years
Recurrence-free survival
From the date of surgery to the date of recurrence or to the end of follow-up
Time frame: 3 years
Locoregional-free survival
From the date of surgery to the date of locoregional recurrence or to the end of follow-up
Time frame: 5 years
Treatment-related morbidity
Common Terminology Criteria for Adverse Events v4.0
Time frame: During the 60th postoperative days
Treatment-related mortality
Time frame: During the 60th postoperative days
Score QLQ-C30
Quality of life is assessed with EORTC questionnaire QLQ-C30
Time frame: 3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure.
Score QLQ-STO 22
Quality of life is assessed with EORTC questionnaire QLQ-STO 22
Time frame: 3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure.
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Département de Chirurgie Digestive, CHU d'Amiens
Amiens, France
Service de Chirurgie Digestive Oncologique, CLCC Paul Papin
Angers, France
Département de Chirurgie Digestive - CHU d'Angers
Angers, France
Service de Chirurgie Digestive, Hôpital Jean Minjoz, CHU Besançon
Besançon, France
Service de Chirurgie Viscérale, CLCC François Baclesse
Caen, France
Service de Chirurgie Viscérale, CHU Estaing
Clermont-Ferrand, France
Service de Chirurgie Digestive, Hôpital du Bocage
Dijon, France
Service de Chirurgie Digestive et de l'Urgence, Hôpital Michallon
Grenoble, France
Service de Chirurgie Digestive et Générale, Hôpital Huriez
Lille, France
Service de Chirurgie Digestive, CLCC Léon Bérard
Lyon, France
...and 23 more locations