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ACTIVE NOT RECRUITING
NCT01882933
PHASE3

D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

PROCEDURE

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