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.
The patient received before the surgery a second line chemotherapy, platinum-based regimen with either carboplatine-paclitaxel, or carboplatine-caelyx. At the end of the six courses IV chemotherapy, if the disease is still responding and if a complete cytoreductive surgery seems possible, the patient is included after signed informed consent and will be operated 5 to 8 weeks after the last second-line chemotherapy cycle. So, during the surgery the patient will be randomized if the complete cytoreductive surgery is really done and will then receive: * either treatment A = maximal cytoreductive surgery without HIPEC * or treatment B = maximal cytoreductive surgery with HIPEC The HIPEC will be done at the end of the surgery. At the end of cytoreductive surgery, tumor residual disease must be null or very limited (Sugarbaker completeness cytoreduction: CC0 (no residual)-CC1 (residual \< 0.25cm). Two methods will be used for the HIPEC: Open or closed abdomen, depends on the site practice. Each site will use the same method during the study for all included patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
415
Maximal cytoreductive surgery
HIPEC: Hyperthermic Intra-PEritoneal Chemotherapy. Administration of cisplatin at 75mg/m²
overall survival
Follow-up of 4 years.
Time frame: from randomization to death (up to 4 years)
relapse free survival
Follow-up of 4 years.
Time frame: from randomization to relapse (up to 4 years)
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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
...and 23 more locations