Can heated chemotherapy improve ovarian cancer outcomes?
NCT ID NCT02217956
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This trial is testing a procedure called HIPEC, where a heated chemotherapy drug (cisplatin) is delivered directly into the abdomen after surgery to remove visible cancer. The goal is to find the safest dose that can be used in patients with advanced ovarian, fallopian tube, or peritoneal cancer who have already received initial chemotherapy. The study focuses on measuring side effects and how long patients remain free of cancer progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cisplatin given as heated chemotherapy directly into the abdomen (HIPEC) after surgery, plus bevacizumab as maintenance therapy
- What this could lead to
- If successful, this could establish a standardized, safe dose of heated intraperitoneal chemotherapy for advanced ovarian cancer, potentially improving disease control after surgery.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the treatment may not prove effective or safe in larger groups. The heated chemotherapy carries risks of toxicity, and the results may not generalize to all patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
30 people
The number who actually took part.
- Start date
-
Jun 2011
- Finished
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Jun 2015
- 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 65 years
- Sex
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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 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: 1. Stage IIIC unresectable ovarian, tubes or peritoneal primitive adenocarcinoma according to FIGO classification previously treated with 6 cycles of carboplatin-cisplatin neoadjuvant chemotherapy with a response allowing complete surgery after the 6 cycles 2. Time frame between the sixth platin injection and the CRS + HCIP \< 10 weeks 3. No disease progression during the neoadjuvant chemotherapy 4. 18 \</= âge \</= 65 ans 5. Performance Status OMS \< 2 6. Hematological function : PNN \>/= 1.5x10\^9/L, platelets \>/= 150x10\^9/L, hemoglobin \> 9 g /dl (transfusion allowed) 7. Hepatic function : Bilirubin \</= 1,5 x LSN, ASAT (SGOT) and ALAT (SGPT) \</= 3 x LSN, Phosphatases alkaline \</= 3 x LSN 8. No kidney related pathology, plasmatic creatinine \< 140 µmol/l, creatinine clearance \> 60 ml/min (Cockcroft formula) and urinary strip \<2 (If urinary strip \>/= 2, proteinuria \< 1g/24h) 9. Plasmatic albumine \> 25 g/l 10. HIV negative status 11. Affiliation to social security 12. Signed informed consent Exclusion Criteria: 1. Incomplete cell kill surgery 2. Non-epithelial ovarian cancer 3. Borderline tumors 4. Non in complete remission previous cancer for more than 5 five years before inclusion 5. Uncontrolled high blood pressure (blood pressure \> 150/100 mm Hg despite antihypertensive treatment) 6. Previous abdominal or pelvic radiotherapy 7. Previous pathology of the central nervous system, except for well controlled pathology like epilepsy 8. Previous stroke, transient ischemic attacks or subarachnoid hemorrhage 9. Previous pulmonary embolism 10. Pregnant or breastfeeding women (Women in age must have a blood negative pregnancy test at least 15 days before going under surgery) 11. Participation to an other clinical trial within 30 days before inclusion in the study 12. Known hypersensitivity to platin or bevacizumab 13. Not healed wound, ulcer or bone fracture 14. Previous haemorrhagic or thrombotic malfunction \< 6 months 15. Significant CArdiovascular disorder including: * Heart attack or unstable angina within the 6 months before inclusion * Grade \> 1 congestive heart failure according to the NYHA classification * Uncontrolled cardiac arrhythmia despite of treatment (patients with atrial fibrillation for which the pace is under control can be include) 16. Long term or recent (within 10 days before inclusion) medication using Aspirin at dosage \> 325 mg/day 17. Long term or recent (within 10 days before inclusion) medication using anticoagulant per os or parenteral or thrombolytic given at full dosage for therapeutic purpose. 18. Grade \> 1 previous sensory and motor neuropathies according to CTC AE V4.0 19. Previous abdominal fistula, GI perforation or intra-abdominal abscess within 6 months before first administration of bevacizumab 20. Proof of any other disease, metabolic malfunction, physical or laboratory exam showing any possibility of disease or condition contraindicating administration of the drug under trial or exsposing the patient to several complications related to the treatment. 21. Persons deprived of liberty 22. Impossibility to comply with the medical following of the treatment for geographical, social or mental reason
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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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Gustave Roussy
Villejuif, Val de Marne, 94805, France
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