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

Gastric Adenocarcinoma Clinical Trial

— GASTRICHIP  

Official title:

GASTRICHIP : D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma. A Randomized and Multicentric Phase III Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01882933
• Other study ID #: 2012.761
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 2013
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 367
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 < 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 :

• 4 months after the treatment with Oxaliplatin for female subjects,

• 6 months after the treatment with Oxaliplatin for male subjects.

Exclusion Criteria:

• Prior malignant tumors with detectable signs of recurrence

• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma
• Stomach Neoplasms

Intervention

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

Country	Name	City	State
France	Département de Chirurgie Digestive, CHU d'Amiens	Amiens
France	Département de Chirurgie Digestive - CHU d'Angers	Angers
France	Service de Chirurgie Digestive Oncologique, CLCC Paul Papin	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, Hôpital Lariboisière	Paris
France	Service de Chirurgie Digestive, Institut Curie	Paris
France	Service de Chirurgie Générale et Digestive, Hôpital Saint-Antoine, APHP	Paris
France	Service de Chirurgie Viscérale et Oncologique, Hôpital Saint-Louis	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	Vandoeuvre lès Nancy
France	Département de Chirurgie Digestive et Hépatobiliaire, Institut Gustave Roussy	Villejuif
Spain	Hospital Universitario Principe de Asturias	Alcalá de Henares
Spain	Hospital Sant Joan Despí Moises Broggi	Barcelona
Spain	Fundación Jiménez Díaz Hospital	Madrid
Spain	Hospital Universitario de Fuenlabrada	Madrid
Spain	Hospital Universitario de La Paz	Madrid
Spain	Md Anderson Cancer Center	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	From the date of surgery to the date of death or to the end of follow-up	5 years
Secondary	Recurrence-free survival	From the date of surgery to the date of recurrence or to the end of follow-up	5 years
Secondary	Recurrence-free survival	From the date of surgery to the date of recurrence or to the end of follow-up	3 years
Secondary	Locoregional-free survival	From the date of surgery to the date of locoregional recurrence or to the end of follow-up	5 years
Secondary	Treatment-related morbidity	Common Terminology Criteria for Adverse Events v4.0	During the 60th postoperative days
Secondary	Treatment-related mortality		During the 60th postoperative days
Secondary	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.
Secondary	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.