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Clinical Trials in Spain / NCT01376752
Active, not recruiting Phase 3

Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment

NCT01376752 · tracked via the Priya Life Science Spain tracker
Sponsor
Phase
Phase 3
Started
2011-04-26
Last updated
2026-05-20

Condition(s) studied

Ovarian Epithelial Cancer Recurrent

Investigational drug(s) / intervention(s)

Maximal cytoreductive surgeryHIPEC →

Maximal cytoreductive surgery: Maximal cytoreductive surgery

HIPEC: HIPEC: Hyperthermic Intra-PEritoneal Chemotherapy. Administration of cisplatin at 75mg/m²

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (33)

FacilityCityRegionStatus
Institut Jules Bordet Brussels Belgium
CHU d'AMIENS Amiens France
Centre Paul Papin Angers France
Institut Bergonie Bordeaux France
Clinique Pasteur Brest France
Polyclinique Kéraudren Brest France
Centre Francois Baclesse Caen France
Centre Jean Perrin Clermont-Ferrand France
Centre hospitalier de Dijon Dijon France
CHU de Grenoble Grenoble France
Clinique Victor Hugo Le Mans France
Pôle Santé Sud Le Mans France
Centre Oscar Lambret Lille France
CHU de Lille Lille France
Centre Hospitalier Universitaire Dupuytren Limoges France
Centre Leon Berard Lyon France
Centre Hopsitalier Lyon Sud Lyon France
Institut Paoli Calmettes Marseille France
AP-HM - Hôpital de la Timone Marseille France
CRLC Val d'Aurelle Montpellier France
Centre Hospitalier Universitaire Nice Nice France
Hopital Lariboisiere Paris France
Hopital Tenon Paris France
Hôpital Européen Georges Pompidou Paris France
Institut Curie Paris France
CHU - Hôpital de la Milétrie Poitiers France
Centre Hospitalier Universitaire Saint Etienne- Hopital Nord Saint-Etienne France
Ico-Centre Rene Gauducheau Saint-Herblain France
CHU Hautepierre Strasbourg France
Institut Claudius Regaud Toulouse France
Centre Alexis Vautrin Vandœuvre-lès-Nancy France
Institut Gustave Roussy Villejuif France
Hospital Universitari Germans Trias I Pujol Badalona Spain

More UNICANCER trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01376752 on ClinicalTrials.gov ↗ ← All trials in Spain