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

This is an interventional treatment trial for Ovarian Epithelial Cancer Recurrent Read More

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