HIPEC After Secondary Cytoreductive Operation in Patients With Platinum-sensitive Recurrence of Ovarian Carcinoma

Inclusion Criteria

• •≥18 years
• •Signed informed consent
• •Patients with platinum-sensitive recurrence after 12-48 months after platinum-based firstline-chemotherapy of histological saved epithelial ovarian carcinoma, primary peritoneal carcinoma or tube carcinoma with planned cytoreductive operation
• •The following histological types can be included: serous, endometrioide, clear cell or undifferentiated carcinoma. Mixed epithelial carcinoma, malignant Brenner Tumour
• •No preceding recurrence chemotherapy
• •Preceding hormontherapy admitted. Concomitant antineoplastic antihormone-therapy (Tamoxifen, Aromataseinhibitoren etc.) not admitted. Low dosed (physiological) hormone-replacement-therapie (HRT) can be administered
• •Patients with maintenance therapy (e.g. Bevacizumab) permitted, assumed recurrence was diagnosed 12 months after primary cytotoxic chemotherapy (also with maintenancetherapy during chemotherapy) and last administration of maintenancetherapy happened min. 21 days before first study protocol intervention
• •Resectability R0 probably, fixed by Desktop II-criteria:
• •Cytoreductive operation at first-diagnosis of the carcinoma R0
• •Ascites \<500 ml
• •ECOG 0
• •R0 status (≤0,5 cm tumour rest) at the end of secondary cytoreductive operation
• •Eligibility for Standard systemic platinum-based combination chemotherapy after sec. cytoreductive operation with or without HIPEC (investigators decision)
• •Bone marrow function: Haemoglobine ≥8.5 g/dL, Absol. neutrophile Granulocytes(ANC) ≥1.000/mm3, Thrombocytes ≥ 100.000/mm3
• •Renal function: Serum Creatinin ≤1,5 times the ULN, calculated Creatininclearance (GFR) ≥60ml/min
• •Liver function: Bilirubin ≤1,5 x
• •ALT, AST ≤3 x ULN
• •Adequate coagulation parameter: INR-value ≤1,5, aPTT ≤1,5 x ULN
• •For patients under fully-dosed/therapeutic Warfarin- or Phenprocoumontherapy INR between 2-3 and aPTT \<1,2 x ULN
• •Neurol. Function: peripheral Neuropathy ≤Grade 2 (CTCAE v4.03 criteria)
• •In women with childbearing potential availability of a neg. serum pregnancy test 2 weeks before planned sec. cytored. operation + effective contraception during study period guaranteed