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Open Access Study protocol

GASTRICHIP: D2 resection and hyperthermic intraperitoneal chemotherapy in locally advanced gastric carcinoma: a randomized and multicenter phase III study

Olivier Glehen12*, Guillaume Passot12, Laurent Villeneuve345, Delphine Vaudoyer12, Sylvie Bin-Dorel345, Gilles Boschetti6, Eric Piaton7 and Alfredo Garofalo8

Author Affiliations

1 Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Service de Chirurgie Viscérale et Endocrinienne, Pierre-Bénite Cedex 69495, France

2 Université Lyon 1, EMR 3738, Oullins 69921, France

3 Hospices Civils de Lyon, Unité de Recherche Clinique, Pôle Information Médicale Evaluation Recherche, Hospices Civils de Lyon, Lyon 69003, France

4 Université de Lyon, EAM Santé Individu Société 4128, Lyon 69003, France

5 Université Lyon 1, Lyon 69003, France

6 Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Service de Gastroentérologie, Pierre-Bénite Cedex 69495, France

7 Hospices Civils de Lyon, Centre de pathologie Est, Bron 69577, France

8 Reparto di Chirurgia Oncologica, Institutio Nazionale Tumori Regina, Roma 00144, Italia

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BMC Cancer 2014, 14:183  doi:10.1186/1471-2407-14-183

Published: 14 March 2014

Abstract

Background

In Europe, gastric cancer remains diagnosed at advanced stage (serosal and/or lymph node involvement). Despite curative management combining perioperative systemic chemotherapy and gastrectomy with D1-D2 lymph node dissection, 5-year survival rates of T3 and/or N + patients remain under 30%. More than 50% of recurrences are peritoneal and/or locoregional. The use of adjuvant hyperthermic intraperitoneal chemotherapy that eliminates free cancer cells that can be released into peritoneal cavity during the gastrectomy and prevents peritoneal carcinomatosis recurrences, was extensively evaluated by several randomized trials conducted in Asia. Two meta-analysis reported that adjuvant hyperthermic intraperitoneal chemotherapy significantly reduces the peritoneal recurrences and significantly improves the overall survival. As it was previously done for the evaluation of the extension of lymph node dissection, it seems very important to validate on European or caucasian patients the results observed in trials performed in Asia.

Methods/design

GASTRICHIP is a prospective, open, randomized multicenter phase III clinical study with two arms that aims to evaluate the effects of hyperthermic intraperitoneal chemotherapy with oxaliplatin on patients with gastric cancer involving the serosa and/or lymph node involvement and/or with positive cytology at peritoneal washing, treated with perioperative systemic chemotherapy and D1-D2 curative gastrectomy. Peroperatively, at the end of curative surgery, patients will be randomized after preoperatively written consent has been given for participation. Primary endpoint will be overall survival from the date of surgery to the date of death or to the end of follow-up (5 years). Secondary endpoint will be 3- and 5-year recurrence-free survival, site of recurrence, morbidity, and quality of life. An ancillary study will compare the incidence of positive peritoneal cytology pre- and post-gastrectomy in two arms of the study, and assess its impact on 5-year survival. The number of patients to be randomized was calculated to be 306.

Trial registration

EudraCT number: 2012-005748-12, ClinicalTrials.gov identifier: NCT01882933.

Keywords:
Gastric adenocarcinoma; Hyperthermic intraperitoneal chemotherapy; Oxaliplatin; Peritoneal carcinomatosis