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)
overall survival — from randomization to death (up to 4 years) Follow-up of 4 years.
Trial sites (33)
Facility
City
Region
Status
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
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.
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