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D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma
Sponsor: Hospices Civils de Lyon
Summary
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.
Official title: GASTRICHIP : D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma. A Randomized and Multicentric Phase III Study.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
367
Start Date
2013-06
Completion Date
2026-05
Last Updated
2024-05-08
Healthy Volunteers
No
Conditions
Interventions
HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin
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.
Curative gastrectomy
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
Locations (33)
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
Service d'Oncologie Digestive, Hôpital de la Timone
Marseille, France
Service de Chirurgie Digestive, CRLC Val d'Aurelle
Montpellier, France
Service de Chirurgie Digestive, CLCC René Gauducheau
Nantes, France
Service de Chirurgie Digestive, Hôpital Archet II
Nice, France
Service de Chirurgie Digestive, Institut Curie
Paris, France
Service de Chirurgie Viscérale et Oncologique, Hôpital Saint-Louis
Paris, France
Service de Chirurgie Générale et Digestive, Hôpital Saint-Antoine, APHP
Paris, France
Service de Chirurgie Digestive, Hôpital Lariboisière
Paris, France
Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, France
Service de Chirurgie Viscérale, CHU de Poitiers
Poitiers, France
Service de Chirurgie Générale et Viscérale, CHU de Reims - Hôpital Robert Debré
Reims, France
Service de Chirurgie Digestive et de Physiologie Digestive, Hôpital Ch. Nicolle
Rouen, France
Service de Chirurgie Digestive, Hôpital Nord
Saint-Etienne, France
Service de Chirurgie Viscérale et Digestive, Hôpital de Hautepierre
Strasbourg, France
Service de Chirurgie Générale et Digestive, Hôpital Purpan
Toulouse, France
Service de Chirurgie Digestive Oncologique, CLCC Alexis Vautrin
Vandœuvre-lès-Nancy, France
Département de Chirurgie Digestive et Hépatobiliaire, Institut Gustave Roussy
Villejuif, France
Hospital Universitario Principe de Asturias
Alcalá de Henares, Spain
Hospital Sant Joan Despí Moises Broggi
Barcelona, Spain
Md Anderson Cancer Center
Madrid, Spain
Fundación Jiménez Díaz Hospital
Madrid, Spain
Hospital Universitario de La Paz
Madrid, Spain
Hospital Universitario de Fuenlabrada
Madrid, Spain