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

April 18, 2023 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

367

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • Département de Chirurgie Digestive, CHU d'Amiens
      • Angers, France, 49033
        • Service de Chirurgie Digestive Oncologique, CLCC Paul Papin
      • Angers, France, 49100
        • Département de Chirurgie Digestive - CHU d'Angers
      • Besançon, France, 25030
        • Service de Chirurgie Digestive, Hôpital Jean Minjoz, CHU Besançon
      • Caen, France, 14076
        • Service de Chirurgie Viscérale, CLCC François Baclesse
      • Clermont-Ferrand, France, 63003
        • Service de Chirurgie Viscérale, CHU Estaing
      • Dijon, France, 21079
        • Service de Chirurgie Digestive, Hôpital du Bocage
      • Grenoble, France, 38043
        • Service de Chirurgie Digestive et de l'Urgence, Hôpital Michallon
      • Lille, France, 59067
        • Service de Chirurgie Digestive et Générale, Hôpital Huriez
      • Lyon, France, 69373
        • Service de Chirurgie Digestive, CLCC Léon Bérard
      • Marseille, France, 13005
        • Service d'Oncologie Digestive, Hôpital de la Timone
      • Montpellier, France, 34298
        • Service de Chirurgie Digestive, CRLC Val d'Aurelle
      • Nantes, France, 44805
        • Service de Chirurgie Digestive, CLCC René Gauducheau
      • Nice, France, 06200
        • Service de Chirurgie Digestive, Hôpital Archet II
      • Paris, France, 75005
        • Service de Chirurgie Digestive, Institut Curie
      • Paris, France, 75010
        • Service de Chirurgie Viscérale et Oncologique, Hôpital Saint-Louis
      • Paris, France, 75012
        • Service de Chirurgie Générale et Digestive, Hôpital Saint-Antoine, APHP
      • Paris, France, 75475
        • Service de Chirurgie Digestive, Hôpital Lariboisière
      • Pierre Bénite, France, 69495
        • Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
      • Poitiers, France, 86021
        • Service de Chirurgie Viscérale, CHU de Poitiers
      • Reims, France, 51092
        • Service de Chirurgie Générale et Viscérale, CHU de Reims - Hôpital Robert Debré
      • Rouen, France, 76031
        • Service de Chirurgie Digestive et de Physiologie Digestive, Hôpital Ch. Nicolle
      • Saint-Etienne, France, 42055
        • Service de Chirurgie Digestive, Hôpital Nord
      • Strasbourg, France, 67200
        • Service de Chirurgie Viscérale et Digestive, Hôpital de Hautepierre
      • Toulouse, France, 31059
        • Service de Chirurgie Générale et Digestive, Hôpital Purpan
      • Vandoeuvre lès Nancy, France, 54511
        • Service de Chirurgie Digestive Oncologique, CLCC Alexis Vautrin
      • Villejuif, France, 94805
        • Département de Chirurgie Digestive et Hépatobiliaire, Institut Gustave Roussy
  • Spain
      • Alcalá de Henares, Spain, 28805
        • Hospital Universitario Príncipe de Asturias
      • Barcelona, Spain, 08970
        • Hospital Sant Joan Despi Moises Broggi
      • Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
      • Madrid, Spain, 28033
        • MD Anderson Cancer Center
      • Madrid, Spain, 28046
        • Hospital Universitario de La Paz
      • Madrid, Spain, 28040
        • Fundación Jiménez Díaz Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Curative Gastrectomy + HIPEC
Curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin
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
Other: Curative Gastrectomy
Curative gastrectomy with D1-D2 lymph node dissection
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
From the date of surgery to the date of death or to the end of follow-up
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival
Time Frame: 5 years
From the date of surgery to the date of recurrence or to the end of follow-up
5 years
Recurrence-free survival
Time Frame: 3 years
From the date of surgery to the date of recurrence or to the end of follow-up
3 years
Locoregional-free survival
Time Frame: 5 years
From the date of surgery to the date of locoregional recurrence or to the end of follow-up
5 years
Treatment-related morbidity
Time Frame: During the 60th postoperative days
Common Terminology Criteria for Adverse Events v4.0
During the 60th postoperative days
Treatment-related mortality
Time Frame: During the 60th postoperative days
During the 60th postoperative days
Score QLQ-C30
Time Frame: 3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure.
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
Time Frame: 3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Anticipated)

May 1, 2026

Study Completion (Anticipated)

May 1, 2026

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012.761

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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