Clinical trial · Interventional
Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment
A Phase III Randomized Study Evaluating Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in the Treatment of Relapse Ovarian Cancer
NCT01376752CI-TRIAL-00112208CHIPORactive not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial ovarian cancer is able to improve the median Overall Survival (OS) by 12 months. In that hypothesis, with alpha risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years follow-up, the number of patients to include is 404. Taking into account a 10% failure, an overall number of 444 patients is required.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Epithelial Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIPEC | Drug | Hyperthermic Intraperitoneal Chemotherapy | ALIAS |
| Maximal cytoreductive surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- maximal cytoreductive surgery without HIPEC
- description
- The participant will have a regular cytoreductive surgery without the adjunction of HIPEC.
- interventionNames
- Procedure: Maximal cytoreductive surgery
- type
- EXPERIMENTAL
- label
- maximal cytoreductive surgery with HIPEC
- description
- The participant will have a regular cytoreductive surgery, then the adjunction of HIPEC: hyperthermic cisplatin will be used at 75mg/m²
- interventionNames
- Procedure: Maximal cytoreductive surgery
- Drug: HIPEC
Primary outcomes (1)
- measure
- overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTBrigand C, Monneuse O, Mohamed F, Sayag-Beaujard AC, Isaac S, Gilly FN, Glehen O. Peritoneal mesothelioma treated by cytoreductive surgery and intraperitoneal hyperthermic chemotherapy: results of a prospective study. Ann Surg Oncol. 2006 Mar;13(3):405-12. doi: 10.1245/ASO.2006.05.041. Epub 2006 Jan 30. PMID 16485159
- RESULTArmstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985. PMID 16394300
- DERIVEDClasse JM, Meeus P, Hudry D, Wernert R, Quenet F, Marchal F, Houvenaeghel G, Bats AS, Lecuru F, Ferron G, Brigand C, Berton D, Gladieff L, Joly F, Ray-Coquard I, Durand-Fontanier S, Liberale G, Pocard M, Georgeac C, Gouy S, Guilloit JM, Guyon F, Costan C, Rousselet JM, de Guerke L, Bakrin N, Brument E, Martin E, Asselain B, Campion L, Glehen O; UNICANCER/CHIPOR Investigators. Hyperthermic intraperitoneal chemotherapy for recurrent ovarian cancer (CHIPOR): a randomised, open-label, phase 3 trial. Lancet Oncol. 2024 Dec;25(12):1551-1562. doi: 10.1016/S1470-2045(24)00531-X. Epub 2024 Nov 14. PMID 39549720