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

August 21, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
367

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Vandœuvre-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 Despí 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olivier GLEHEN, MD, Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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