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

NCT01882933 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 2012.761
• Study Type: interventional
• Target: 367
• Locations: 2 countries
• Sites: 33

Brief 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.

Conditions

Gastric Adenocarcinoma

Keywords

Gastric adenocarcinoma; HIPEC; Oxaliplatin; Signet ring cell

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From the date of surgery to the date of death or to the end of follow-up

  5 years

Secondary Outcomes (7)

• Recurrence-free survival

  5 years

• Recurrence-free survival

  3 years

• Locoregional-free survival

  5 years

• Treatment-related morbidity

  During the 60th postoperative days

• Treatment-related mortality

  During the 60th postoperative days

Study Arms (2)

Curative Gastrectomy + HIPEC

EXPERIMENTAL

Curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin

Drug: HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin; Procedure: Curative gastrectomy

Curative Gastrectomy

OTHER

Curative gastrectomy with D1-D2 lymph node dissection

Procedure: Curative gastrectomy

Interventions

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.

Curative Gastrectomy + HIPEC

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

Curative Gastrectomy; Curative Gastrectomy + HIPEC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \< age ≤ 75 years old
• 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 :
• months after the treatment with Oxaliplatin for female subjects,
• months after the treatment with Oxaliplatin for male subjects.

You may not qualify if:

• Prior malignant tumors with detectable signs of recurrence
• Gastric stump adenocarcinoma
• Presence of comorbidities, notably serious chronic diseases or organ failure General conditions
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (33)

Département de Chirurgie Digestive, CHU d'Amiens

Amiens, 80054, France

Location

Service de Chirurgie Digestive Oncologique, CLCC Paul Papin

Angers, 49033, France

Location

Département de Chirurgie Digestive - CHU d'Angers

Angers, 49100, France

Location

Service de Chirurgie Digestive, Hôpital Jean Minjoz, CHU Besançon

Besançon, 25030, France

Location

Service de Chirurgie Viscérale, CLCC François Baclesse

Caen, 14076, France

Location

Service de Chirurgie Viscérale, CHU Estaing

Clermont-Ferrand, 63003, France

Location

Service de Chirurgie Digestive, Hôpital du Bocage

Dijon, 21079, France

Location

Service de Chirurgie Digestive et de l'Urgence, Hôpital Michallon

Grenoble, 38043, France

Location

Service de Chirurgie Digestive et Générale, Hôpital Huriez

Lille, 59067, France

Location

Service de Chirurgie Digestive, CLCC Léon Bérard

Lyon, 69373, France

Location

Service d'Oncologie Digestive, Hôpital de la Timone

Marseille, 13005, France

Location

Service de Chirurgie Digestive, CRLC Val d'Aurelle

Montpellier, 34298, France

Location

Service de Chirurgie Digestive, CLCC René Gauducheau

Nantes, 44805, France

Location

Service de Chirurgie Digestive, Hôpital Archet II

Nice, 06200, France

Location

Service de Chirurgie Digestive, Institut Curie

Paris, 75005, France

Location

Service de Chirurgie Viscérale et Oncologique, Hôpital Saint-Louis

Paris, 75010, France

Location

Service de Chirurgie Générale et Digestive, Hôpital Saint-Antoine, APHP

Paris, 75012, France

Location

Service de Chirurgie Digestive, Hôpital Lariboisière

Paris, 75475, France

Location

Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

Service de Chirurgie Viscérale, CHU de Poitiers

Poitiers, 86021, France

Location

Service de Chirurgie Générale et Viscérale, CHU de Reims - Hôpital Robert Debré

Reims, 51092, France

Location

Service de Chirurgie Digestive et de Physiologie Digestive, Hôpital Ch. Nicolle

Rouen, 76031, France

Location

Service de Chirurgie Digestive, Hôpital Nord

Saint-Etienne, 42055, France

Location

Service de Chirurgie Viscérale et Digestive, Hôpital de Hautepierre

Strasbourg, 67200, France

Location

Service de Chirurgie Générale et Digestive, Hôpital Purpan

Toulouse, 31059, France

Location

Service de Chirurgie Digestive Oncologique, CLCC Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Département de Chirurgie Digestive et Hépatobiliaire, Institut Gustave Roussy

Villejuif, 94805, France

Location

Hospital Universitario Principe de Asturias

Alcalá de Henares, 28805, Spain

Location

Hospital Sant Joan Despí Moises Broggi

Barcelona, 08970, Spain

Location

Md Anderson Cancer Center

Madrid, 28033, Spain

Location

Fundación Jiménez Díaz Hospital

Madrid, 28040, Spain

Location

Hospital Universitario de La Paz

Madrid, 28046, Spain

Location

Hospital Universitario de Fuenlabrada

Madrid, 28942, Spain

Location

Related Publications (1)

• 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.

  PMID: 24628950 DERIVED

MeSH Terms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Olivier GLEHEN, MD

  Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 21, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

ES (6); FR (27)