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Heated chemotherapy during surgery may delay ovarian cancer return

NCT ID NCT03842982

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tests whether giving heated chemotherapy directly into the abdomen during surgery can help people with advanced ovarian cancer live longer without the disease coming back. About 362 participants will either receive standard surgery alone or surgery plus the heated chemotherapy. The study is active but no longer recruiting, and results are awaited.

What this could mean

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

Active substance
Cisplatin (heated chemotherapy given directly into the abdomen during surgery)
What this could lead to
If successful, this could offer a way to delay ovarian cancer recurrence after surgery, giving patients more time without the disease progressing.
What could go wrong
This is a phase 3 trial, but results are not yet final. The heated chemotherapy adds complexity and risk of side effects, 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

About 362 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2019

Expected to finish

Feb 2031

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 to 76 years

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: Pre-eligibility criteria to be checked before surgery for pre-registration 1. Age ≥18 years and ≤ 76 years 2. Histologically proven primary epithelial ovarian carcinoma or fallopian tube carcinoma or peritoneal carcinoma (including serous papillary adenocarcinoma, clear-cell carcinoma, mucinous adenocarcinoma and endometrioid carcinoma) 3. Pre-therapeutic FIGO (International Federation of Gynecology and Obstetrics) stage III 4. Patient eligible for 1. Primary Debulking Surgery (PDS) with planned adjuvant chemotherapy +/- bevacizumab or other targeted therapy 2. Or Interval Debulking Surgery (IDS) after neo-adjuvant chemotherapy +/- bevacizumab or other targeted therapy, with or without planned adjuvant chemotherapy +/- bevacizumab or other targeted therapy. In case of neo-adjuvant chemotherapy, surgery should be performed in a time interval of 3 to 5 weeks in case of chemotherapy without bevacizumab, and in a time interval of 4 to 6 weeks if chemotherapy is combined with bevacizumab. The patient remains eligible for the study if surgery is delayed beyond the recommended time interval. 5. WHO (World Health Organization Performance Status) ≤ 2 6. Physical status score ASA (American Society of Anesthesiologists) ≤ 2 7. Adequate bone marrow and renal function, as evidenced by the following tests performed within 7 days prior to surgery: * Absolute Neutrophil Count (ANC) ≥1,500/mm3 * Platelets ≥100,000/mm3 * Aspartate aminotransferase (ALT)/ Alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) (≤5.0 × ULN in case of liver metastases) * Total bilirubin ≤1.5 × ULN (except in case of Gilbert's disease) * Creatinine clearance ≥ 60 mL/ min 8. Negative serum pregnancy test within 7 days prior to surgery for women of childbearing potential. For non-menopausal women, if no hysterectomy is planned, willing to accept the use of an effective contraceptive regimen during the treatment period and at least 6 months after the end of treatment (surgery or adjuvant chemotherapy) 9. Absence of contraindication to receive the products used in this study (cisplatin and products used in neo-adjuvant/ adjuvant chemotherapy) according to the most recent SmPC (Summary of Product Characteristics) of these products 10. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up 11. Signed written informed consent 12. Patient covered by the French or Belgian "Social Security" regime Criteria to be checked per-operatively for confirmation of enrolment and randomization 13. Residual disease after surgery (cytoreduction score CC) CC-0 (no macroscopic residue) or CC-1 (residue \< 2.5 mm) 14. Per-operative hemorrhage \< 2.5 L 15. Strictly less than 3 digestive resections performed during surgery 16. Diuresis maintained during surgery, without oliguria or anuria (per-operatory diuresis ≥ 0,5 mL/ kg/ h) Exclusion Criteria: 1. Benign disease, borderline disease, non epithelial ovarian carcinoma or carcinosarcoma 2. Cirrhosis 3. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation 4. Auditory impairment 5. Dehydration or intercurrent disease that contraindicates hyperhydration (including cardio-respiratory disease) 6. Other uncontrolled intercurrent disease including, but not limited to: diabetes; hypertension; symptomatic congestive heart or pulmonary failure; renal, hepatic or severe gastrointestinal (associated with diarrhea) chronic disease 7. Any unresolved NCI-CTCAE Grade ≥ 2 toxicity from previous anticancer therapy (excluding alopecia) 8. Concomitant treatment with prophylactic phenytoin 9. Receipt of live attenuated vaccine, including yellow fever vaccine, within 30 days prior to inclusion (and, if patient is enrolled, up to 30 days after the last administration of study treatment) 10. Pregnant or breastfeeding woman 11. Psychiatric illness or social situation that would limit compliance with study requirement, substantially increase the risk of side effects, or compromise the ability of the patient to give written informed consent 12. Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons) 13. Person under guardianship

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Centre François Baclesse

    Caen, 14076, France

  • Centre Henri Becquerel

    Rouen, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Clinique Mathilde

    Rouen, 76100, France

  • Cliniques universitaires St-Luc, Institut Roi Albert II

    Brussels, 1200, Belgium

  • Hôpital Européen Georges Pompidou

    Paris, 75008, France

  • Hôpital Jeanne de Flandre

    Lille, 59037, France

  • Hôpital de Hautepierre

    Strasbourg, France

  • ICM-Val d'Aurelle

    Montpellier, 34298, France

  • Institut Bergonié

    Bordeaux, 33076, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Jules Bordet

    Brussels, 1070, Belgium

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519, France

  • Institut de Cancérologie de l'Ouest

    Angers, 49055, France

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44800, France

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