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A prospective, opened, multicentric, randomised, phase III trial with two arms:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curative Gastrectomy + HIPEC | Experimental | Curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin |
|
| Curative Gastrectomy | Other | Curative gastrectomy with D1-D2 lymph node dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From the date of surgery to the date of death or to the end of follow-up | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival | From the date of surgery to the date of recurrence or to the end of follow-up | 5 years |
| Recurrence-free survival | From the date of surgery to the date of recurrence or to the end of follow-up |
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Inclusion Criteria:
AND/OR
Perforated gastric adenocarcinoma AND/OR
Siewert III adenocarcinoma of the cardia for which a gastrectomy by exclusive abdominal laparotomy is scheduled
Females of childbearing age potential and male subjects with partners of childbearing potential using efficient contraceptive measures (as judged by the investigator).Subjects randomised in the arm with HIPEC should be informed and accept that these requirements should also extend to :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier GLEHEN, MD | Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département de Chirurgie Digestive, CHU d'Amiens | Amiens | 80054 | France | |||
| Service de Chirurgie Digestive Oncologique, CLCC Paul Papin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24628950 | Derived | Glehen O, Passot G, Villeneuve L, Vaudoyer D, Bin-Dorel S, Boschetti G, Piaton E, Garofalo A. GASTRICHIP: D2 resection and hyperthermic intraperitoneal chemotherapy in locally advanced gastric carcinoma: a randomized and multicenter phase III study. BMC Cancer. 2014 Mar 14;14:183. doi: 10.1186/1471-2407-14-183. |
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|
| Curative gastrectomy | Procedure | 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 |
|
| 3 years |
| Locoregional-free survival | From the date of surgery to the date of locoregional recurrence or to the end of follow-up | 5 years |
| Treatment-related morbidity | Common Terminology Criteria for Adverse Events v4.0 | During the 60th postoperative days |
| Treatment-related mortality | During the 60th postoperative days |
| Score QLQ-C30 | Quality of life is assessed with EORTC questionnaire QLQ-C30 | 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 | 3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure. |
| Angers |
| 49033 |
| France |
| Département de Chirurgie Digestive - CHU d'Angers | Angers | 49100 | France |
| Service de Chirurgie Digestive, Hôpital Jean Minjoz, CHU Besançon | Besançon | 25030 | France |
| Service de Chirurgie Viscérale, CLCC François Baclesse | Caen | 14076 | France |
| Service de Chirurgie Viscérale, CHU Estaing | Clermont-Ferrand | 63003 | France |
| Service de Chirurgie Digestive, Hôpital du Bocage | Dijon | 21079 | France |
| Service de Chirurgie Digestive et de l'Urgence, Hôpital Michallon | Grenoble | 38043 | France |
| Service de Chirurgie Digestive et Générale, Hôpital Huriez | Lille | 59067 | France |
| Service de Chirurgie Digestive, CLCC Léon Bérard | Lyon | 69373 | France |
| Service d'Oncologie Digestive, Hôpital de la Timone | Marseille | 13005 | France |
| Service de Chirurgie Digestive, CRLC Val d'Aurelle | Montpellier | 34298 | France |
| Service de Chirurgie Digestive, CLCC René Gauducheau | Nantes | 44805 | France |
| Service de Chirurgie Digestive, Hôpital Archet II | Nice | 06200 | France |
| Service de Chirurgie Digestive, Institut Curie | Paris | 75005 | France |
| Service de Chirurgie Viscérale et Oncologique, Hôpital Saint-Louis | Paris | 75010 | France |
| Service de Chirurgie Générale et Digestive, Hôpital Saint-Antoine, APHP | Paris | 75012 | France |
| Service de Chirurgie Digestive, Hôpital Lariboisière | Paris | 75475 | France |
| Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon | Pierre-Bénite | 69495 | France |
| Service de Chirurgie Viscérale, CHU de Poitiers | Poitiers | 86021 | France |
| Service de Chirurgie Générale et Viscérale, CHU de Reims - Hôpital Robert Debré | Reims | 51092 | France |
| Service de Chirurgie Digestive et de Physiologie Digestive, Hôpital Ch. Nicolle | Rouen | 76031 | France |
| Service de Chirurgie Digestive, Hôpital Nord | Saint-Etienne | 42055 | France |
| Service de Chirurgie Viscérale et Digestive, Hôpital de Hautepierre | Strasbourg | 67200 | France |
| Service de Chirurgie Générale et Digestive, Hôpital Purpan | Toulouse | 31059 | France |
| Service de Chirurgie Digestive Oncologique, CLCC Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| Département de Chirurgie Digestive et Hépatobiliaire, Institut Gustave Roussy | Villejuif | 94805 | France |
| Hospital Universitario Principe de Asturias | Alcalá de Henares | 28805 | Spain |
| Hospital Sant Joan Despí Moises Broggi | Barcelona | 08970 | Spain |
| Md Anderson Cancer Center | Madrid | 28033 | Spain |
| Fundación Jiménez Díaz Hospital | Madrid | 28040 | Spain |
| Hospital Universitario de La Paz | Madrid | 28046 | Spain |
| Hospital Universitario de Fuenlabrada | Madrid | 28942 | Spain |
| ID | Term |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
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