NCT01376752Active, not recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 415 (actual)
- First submitted
- 28 Mar 2011
- Start date
- 26 Apr 2011
- Primary completion date
- 8 Jan 2023
- Lead sponsor
- UNICANCER
- Diseases
- Ovarian cancer
- NCT number
- NCT01376752
- EU CT number
- 2024-517390-24-00
- EudraCT number
- 2010-023035-42
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 415
- From 26 Apr 2011 to the primary completion date, 8 Jan 2023
- 34 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with other concurrent severe life threatening disease
- The need to perform more than two segmental digestive resections during the CRS +/- HIPEC surgery
- Patient already treated with HIPEC for the ovarian cancer
Other illness
- Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma)
- Hypersensitivity to Platinum compound
- Any progressive disease during the IV systemic second-line chemotherapy (platine-based)
- Incomplete cytoreductive surgery with macroscopical residual disease (Sugarbaker \> CC1)
- 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
Age
- Patient age \<18 years
Other
- Distant metastasis
- Use of anti-angiogenic treatment
- Early relapse: less than 6 mois after the end of the first treatment
- Individual deprived of liberty or placed under the authority of a tutor
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (34)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Jules Bordet Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Recruiting |
| INSTITUT DE CANCEROLOGIE DE L’OUEST (ICO), SITE P PAPIN Coordinator of this site? Confirm its status | ANGERS | France | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Clinique Pasteur Lanroze Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Centre Hospitalier Privé de Brest - Keraudren Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Recruiting |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont Ferrand Cedex1 | France | Recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Recruiting |
| Pôle Santé Sud Coordinator of this site? Confirm its status | Le Mans | France | Recruiting |
| Clinique Victor Hugo Coordinator of this site? Confirm its status | Le Mans Cedex 2 | France | Recruiting |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Hospital Claude Huriez Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| CHU Dupuytren Coordinator of this site? Confirm its status | Limosges | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Hôpital La Timone - APHM Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Institut Régional Cancer Montpellier - ICM Val d'Aurelle Coordinator of this site? Confirm its status | MONTPELLIER | France | Recruiting |
| Hôpital Archet 2 Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Tenon Coordinator of this site? Confirm its status | Paris Cedex 20 | France | Recruiting |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| CHRU de Poitiers La Miletrie Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| INSTITUT DE CANCEROLOGIE DE L’OUEST (ICO) RENE GAUDUCHAU Coordinator of this site? Confirm its status | SAINT-HERBLAIN | France | Recruiting |
| Unite De Recherche Clinique HIA Begin Coordinator of this site? Confirm its status | Saint-Mande | France | Recruiting |
| Centre Hospitalier Universitaire De Saint Etienne Coordinator of this site? Confirm its status | St Etienne Cedex 2 | France | Recruiting |
| Hôpital de Hautepierre - Hôpitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Oncopole Claudius Regaud Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
| Institut De Cancerologie De Lorraine Coordinator of this site? Confirm its status | Vandouvre Les Nancy | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.