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Gastric AdenocarcinomaPhase 3GASTRICHIPNCT01882933

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

A Phase 3 study testing HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin and Curative gastrectomy in people with Gastric Adenocarcinoma, run by Hospices Civils de Lyon at 33 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Adenocarcinoma
What is being tested?
HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin and Curative gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
367 participants
Where
33 sitesin 2 countries
Study dates
24 Jun 2013to 30 Jun 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

33 sites in 2 countries.

33 sites in 2 countries

France27 sites

  • Département de Chirurgie Digestive, CHU d'Amiens

    Amiens, 80054

  • Service de Chirurgie Digestive Oncologique, CLCC Paul Papin

    Angers, 49033

  • Département de Chirurgie Digestive - CHU d'Angers

    Angers, 49100

  • Service de Chirurgie Digestive, Hôpital Jean Minjoz, CHU Besançon

    Besançon, 25030

  • Service de Chirurgie Viscérale, CLCC François Baclesse

    Caen, 14076

  • Service de Chirurgie Viscérale, CHU Estaing

    Clermont-Ferrand, 63003

  • Service de Chirurgie Digestive, Hôpital du Bocage

    Dijon, 21079

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

    Grenoble, 38043

  • Service de Chirurgie Digestive et Générale, Hôpital Huriez

    Lille, 59067

  • Service de Chirurgie Digestive, CLCC Léon Bérard

    Lyon, 69373

  • Service d'Oncologie Digestive, Hôpital de la Timone

    Marseille, 13005

  • Service de Chirurgie Digestive, CRLC Val d'Aurelle

    Montpellier, 34298

  • Service de Chirurgie Digestive, CLCC René Gauducheau

    Nantes, 44805

  • Service de Chirurgie Digestive, Hôpital Archet II

    Nice, 06200

  • Service de Chirurgie Digestive, Institut Curie

    Paris, 75005

  • Service de Chirurgie Viscérale et Oncologique, Hôpital Saint-Louis

    Paris, 75010

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

    Paris, 75012

  • Service de Chirurgie Digestive, Hôpital Lariboisière

    Paris, 75475

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

    Pierre-Bénite, 69495

  • Service de Chirurgie Viscérale, CHU de Poitiers

    Poitiers, 86021

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

    Reims, 51092

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

    Rouen, 76031

  • Service de Chirurgie Digestive, Hôpital Nord

    Saint-Etienne, 42055

  • Service de Chirurgie Viscérale et Digestive, Hôpital de Hautepierre

    Strasbourg, 67200

  • Service de Chirurgie Générale et Digestive, Hôpital Purpan

    Toulouse, 31059

  • Service de Chirurgie Digestive Oncologique, CLCC Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Département de Chirurgie Digestive et Hépatobiliaire, Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Spain6 sites

  • Hospital Universitario Principe de Asturias

    Alcalá de Henares, 28805

  • Hospital Sant Joan Despí Moises Broggi

    Barcelona, 08970

  • Md Anderson Cancer Center

    Madrid, 28033

  • Fundación Jiménez Díaz Hospital

    Madrid, 28040

  • Hospital Universitario de La Paz

    Madrid, 28046

  • Hospital Universitario de Fuenlabrada

    Madrid, 28942

Other trials in Spain

About this study

Official title: 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.

Being tested
HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin, Curative gastrectomy
Keywords
Gastric adenocarcinoma, HIPEC, Oxaliplatin, Signet ring cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatinDrug

    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 gastrectomyProcedure or surgery

    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

Study groups in NCT01882933
Study groupRoleWhat they receive
Curative Gastrectomy + HIPECExperimentalCurative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin
Receives: Drug: HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin; Procedure: Curative gastrectomy
Curative GastrectomyOtherCurative gastrectomy with D1-D2 lymph node dissection
Receives: Procedure: Curative gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

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

    Measured: 5 years

Secondary outcomes (7)

  1. Recurrence-free survival

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

    Measured: 5 years

  2. Recurrence-free survival

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

    Measured: 3 years

  3. Locoregional-free survival

    From the date of surgery to the date of locoregional recurrence or to the end of follow-up

    Measured: 5 years

  4. Treatment-related morbidity

    Common Terminology Criteria for Adverse Events v4.0

    Measured: During the 60th postoperative days

  5. Treatment-related mortality

    Measured: During the 60th postoperative days

  6. Score QLQ-C30

    Quality of life is assessed with EORTC questionnaire QLQ-C30

    Measured: 3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure.

  7. Score QLQ-STO 22

    Quality of life is assessed with EORTC questionnaire QLQ-STO 22

    Measured: 3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2013 (estimated)
  2. Study start24 Jun 2013
  3. Primary completion30 Jun 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
367 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01882933
Sponsor's protocol ID
2012.761
Acronym
GASTRICHIP
Status last verified
Aug 2026
First submitted
13 Jun 2013
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24628950

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin and Curative gastrectomy in people with Gastric Adenocarcinoma, run by Hospices Civils de Lyon at 33 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01882933, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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