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Can heated chemotherapy boost survival in stomach cancer?

NCT ID NCT01882933

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This phase III trial is investigating whether adding heated chemotherapy (HIPEC) to standard surgery improves survival for people with advanced stomach cancer. Participants are randomly assigned to receive either surgery alone or surgery plus HIPEC, where a heated chemotherapy solution is circulated in the abdomen during the operation. The study aims to see if this extra step helps patients live longer without the cancer returning.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Heated chemotherapy (oxaliplatin) delivered directly into the abdomen during surgery (HIPEC)
What this could lead to
If successful, this approach could become a standard addition to surgery for advanced gastric cancer, potentially improving long-term survival.
What could go wrong
The trial is still in progress, and results are not yet known. HIPEC carries risks like infection or kidney issues, and it may not improve survival for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

367 people

The number who actually took part.

Started

Jun 2013

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric adenocarcinoma

Contacts and locations

Locations

  • Département de Chirurgie Digestive - CHU d'Angers

    Angers, 49100, France

  • Département de Chirurgie Digestive et Hépatobiliaire, Institut Gustave Roussy

    Villejuif, 94805, France

  • Département de Chirurgie Digestive, CHU d'Amiens

    Amiens, 80054, France

  • Fundación Jiménez Díaz Hospital

    Madrid, 28040, Spain

  • Hospital Sant Joan Despí Moises Broggi

    Barcelona, 08970, Spain

  • Hospital Universitario Principe de Asturias

    Alcalá de Henares, 28805, Spain

  • Hospital Universitario de Fuenlabrada

    Madrid, 28942, Spain

  • Hospital Universitario de La Paz

    Madrid, 28046, Spain

  • Md Anderson Cancer Center

    Madrid, 28033, Spain

  • Service d'Oncologie Digestive, Hôpital de la Timone

    Marseille, 13005, France

  • Service de Chirurgie Digestive Oncologique, CLCC Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511, France

  • Service de Chirurgie Digestive Oncologique, CLCC Paul Papin

    Angers, 49033, France

  • Service de Chirurgie Digestive et Générale, Hôpital Huriez

    Lille, 59067, France

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

    Rouen, 76031, France

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

    Grenoble, 38043, France

  • Service de Chirurgie Digestive, CLCC Léon Bérard

    Lyon, 69373, France

  • Service de Chirurgie Digestive, CLCC René Gauducheau

    Nantes, 44805, France

  • Service de Chirurgie Digestive, CRLC Val d'Aurelle

    Montpellier, 34298, France

  • Service de Chirurgie Digestive, Hôpital Archet II

    Nice, 06200, France

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

    Besançon, 25030, France

  • Service de Chirurgie Digestive, Hôpital Lariboisière

    Paris, 75475, France

  • Service de Chirurgie Digestive, Hôpital Nord

    Saint-Etienne, 42055, France

  • Service de Chirurgie Digestive, Hôpital du Bocage

    Dijon, 21079, France

  • Service de Chirurgie Digestive, Institut Curie

    Paris, 75005, France

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

    Pierre-Bénite, 69495, France

  • Service de Chirurgie Générale et Digestive, Hôpital Purpan

    Toulouse, 31059, France

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

    Paris, 75012, France

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

    Reims, 51092, France

  • Service de Chirurgie Viscérale et Digestive, Hôpital de Hautepierre

    Strasbourg, 67200, France

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

    Paris, 75010, France

  • Service de Chirurgie Viscérale, CHU Estaing

    Clermont-Ferrand, 63003, France

  • Service de Chirurgie Viscérale, CHU de Poitiers

    Poitiers, 86021, France

  • Service de Chirurgie Viscérale, CLCC François Baclesse

    Caen, 14076, France

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