D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma
NCT ID: NCT01882933
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
367 participants
INTERVENTIONAL
2013-06-30
2026-05-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Curative Gastrectomy + HIPEC
Curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin
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
Curative Gastrectomy
Curative gastrectomy with D1-D2 lymph node dissection
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* White blood cells \> 3,500/mm3, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
* Good renal functions, serum creatinine values being \< 1.5 mg/dl and creatinine clearance \> 60 ml/min
* Performance Status ≤1, Karnofsky Index ≥ 70%
* Serum bilirubin ≤ 2 mg/dl
* Having given written informed consent prior to any procedure related to the study.
* Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
* Not under any administrative or legal supervision
* Histologically evidenced resectable T3 or T4 gastric adenocarcinoma for which a curative gastrectomy is scheduled, with invasion into the serosa AND/OR lymph node metastasis (determined from data obtained by endoscopic ultrasound and chest, abdomen and pelvis CT scan) AND/OR positive peritoneal cytology (sampled during the preoperative laparoscopy).
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 :
* 4 months after the treatment with Oxaliplatin for female subjects,
* 6 months after the treatment with Oxaliplatin for male subjects.
Exclusion Criteria
* Gastric stump adenocarcinoma
* Presence of comorbidities, notably serious chronic diseases or organ failure General conditions
* Any subject in exclusion period of a previous study according to applicable regulations
* Pregnancy or breastfeeding
* Females of childbearing age potential or male subjects with partners of childbearing potential not using medically accepted contraceptive measures, as judged by the investigator Interfering substance
* Contraindication to any drug contained in the chemotherapy regimen Specific to the study
* Life threatening toxicity before surgery
* Distant metastases (liver, lung. ovaries, etc)
* Tumoral infiltration of the head or body of the pancreas
* Patients presenting an adenocarcinoma of the cardia Siewert I or II
* Existence of macroscopic peritoneal implants
* Patients with clinically significant ascites (\> 500 cc) even if cytology is negative for cancer cells, in the absence of other non-malignant causes of ascites
18 Years
75 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Olivier GLEHEN, MD
Role: PRINCIPAL_INVESTIGATOR
Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Locations
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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
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
Countries
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References
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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.
Other Identifiers
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2012.761
Identifier Type: -
Identifier Source: org_study_id
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