Heated chemotherapy during surgery may delay ovarian cancer return
NCT ID NCT03842982
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 362 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2019
- Expected to finish
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Feb 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 76 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
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Centre François Baclesse
Caen, 14076, France
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Centre Henri Becquerel
Rouen, France
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Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
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Centre Jean Perrin
Clermont-Ferrand, 63011, France
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Centre Oscar Lambret
Lille, 59020, France
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Clinique Mathilde
Rouen, 76100, France
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Cliniques universitaires St-Luc, Institut Roi Albert II
Brussels, 1200, Belgium
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Hôpital Européen Georges Pompidou
Paris, 75008, France
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Hôpital Jeanne de Flandre
Lille, 59037, France
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Hôpital de Hautepierre
Strasbourg, France
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ICM-Val d'Aurelle
Montpellier, 34298, France
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Institut Bergonié
Bordeaux, 33076, France
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Institut Gustave Roussy
Villejuif, 94805, France
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Institut Jules Bordet
Brussels, 1070, Belgium
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Institut Paoli Calmettes
Marseille, 13273, France
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Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
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Institut de Cancérologie de l'Ouest
Angers, 49055, France
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Institut de Cancérologie de l'Ouest
Saint-Herblain, 44800, France
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Other studies related to the condition(s) this trial covers.
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