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Heated chemo during surgery may extend life in ovarian cancer relapse

NCT ID NCT01376752

Disease control Sponsor: UNICANCER 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding heated chemotherapy directly into the abdomen during surgery can help people with relapsed ovarian cancer live longer. About 415 adults whose cancer returned in the abdomen after initial treatment will take part. The approach aims to control the disease and improve survival, but is not a cure.

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

415 people

The number who actually took part.

Started

Apr 2011

Expected to finish

May 2027

An estimate. End dates often move.

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 years and older

Sex

Female participants only

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: * Patient age ≥ 18 years * Performance Status WHO \< 2 * Initially treated for Epithelial Ovarian Carcinoma * Patient with only peritoneal relapse occurred at least 6 month from the initial treatment, resectable without distant metastasis (with the exception of communicating pleura effusion, sensitive to platine-based second line chemotherapy and resectable lymph-nodes in the groin or retro peritoneal) * Platinum based second-line chemotherapy before surgery with either carboplatine-paclitaxel, or carboplatine-caelyx * Complete cytoreductive surgery * The surgery has to be planned 5 to 8 weeks from the last 2nd of chemotherapy * No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit * No Renal insufficiency (serum creatinine \< 1,5 time the normal limit, creatinine clearance \> 80 mL/min). calculated with MDRD method * Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L * No contraindication to general anaesthesia for heavy surgery * Patients having read, signed and dated Informed consent before any study procedure * Childbearing patients have to take appropriate contraceptive methods during the treatment and until 6 months after the treatment Exclusion Criteria: * Patient age \<18 years * Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) * Hypersensitivity to Platinum compound * Distant metastasis * Use of anti-angiogenic treatment * Patient with other concurrent severe life threatening disease * The need to perform more than two segmental digestive resections during the CRS +/- HIPEC surgery * Any progressive disease during the IV systemic second-line chemotherapy (platine-based) * Incomplete cytoreductive surgery with macroscopical residual disease (Sugarbaker \> CC1) * Early relapse: less than 6 mois after the end of the first treatment * Ovarian tumor other than Epithelioma Ovarian Cancer * Uncontrolled infection * Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Clinically significant cardiovascular disease contraindicating the hyper hydratation, which is necessary for HIPEC * Patient already treated with HIPEC for the ovarian cancer * Individual deprived of liberty or placed under the authority of a tutor

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Conditions

The condition(s) this trial relates to.

ovarian carcinoma

As listed by the trial registrant

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

Ovarian epithelial cancer recurrent

Contacts and locations

Locations

  • AP-HM - Hôpital de la Timone

    Marseille, France

  • CHU - Hôpital de la Milétrie

    Poitiers, France

  • CHU Hautepierre

    Strasbourg, 67098, France

  • CHU d'AMIENS

    Amiens, France

  • CHU de Grenoble

    Grenoble, France

  • CHU de Lille

    Lille, France

  • CRLC Val d'Aurelle

    Montpellier, 34298, France

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511, France

  • Centre Francois Baclesse

    Caen, 14076, France

  • Centre Hopsitalier Lyon Sud

    Lyon, 69495, France

  • Centre Hospitalier Universitaire Dupuytren

    Limoges, 87042, France

  • Centre Hospitalier Universitaire Nice

    Nice, 06202, France

  • Centre Hospitalier Universitaire Saint Etienne- Hopital Nord

    Saint-Etienne, 42055, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Centre Paul Papin

    Angers, 49933, France

  • Centre hospitalier de Dijon

    Dijon, France

  • Clinique Pasteur

    Brest, France

  • Clinique Victor Hugo

    Le Mans, France

  • Hopital Lariboisiere

    Paris, 75010, France

  • Hopital Tenon

    Paris, 75020, France

  • Hospital Universitari Germans Trias I Pujol

    Badalona, Spain

  • Hôpital Européen Georges Pompidou

    Paris, France

  • Ico-Centre Rene Gauducheau

    Saint-Herblain, 44805, France

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Claudius Regaud

    Toulouse, 31052, France

  • Institut Curie

    Paris, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Jules Bordet

    Brussels, Belgium

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Polyclinique Kéraudren

    Brest, France

  • Pôle Santé Sud

    Le Mans, France