Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy

stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy

The objective of this study is to prove that treatment with primary cytoreductive surgery in combination with HIPEC (treatment arm) improves outcome compared to primary cytoreductive surgery without HIPEC (standard arm) with acceptable morbidity, in patients with FIGO stage III epithelial ovarian cancer who are eligible for primary cytoreductive surgery with no residual disease, or residual disease up to 2.5 mm.

Inclusion Criteria:

• candidate for primary CRS
• histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer

Exclusion Criteria:

• history of previous malignancies within 5 years prior to inclusion
• FIGO stage IV disease
• complete primary cytoreduction is impossible
• prior treatment for the current malignancy