Primary Cytoreductive Surgery With and Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Ovarian Cancer and Prediction Markers for Treatment Response to HIPEC.

The purpose of this study is to evaluate the role of hyperthermic intraperitoneal chemotherapy (HIPEC) for the overall survival of patients with primary ovarian cancer stage III, eligible for upfront cytoreductive surgery, and to develop a combined analysis to predict the treatment response of ovarian cancer to HIPEC.

Aims:To elucidate the overall survival of patients with primary stage III ovarian cancer after upfront surgery with and without HIPEC.To estimate the impact of HIPEC on treatment toxicity, surgical morbidity, quality of life and cost-effectiveness.To identify predictors of treatment response of ovarian cancer to HIPEC based on the changed expression of blood plasma and platelet proteins, and mRNA in extracellular vesicles.Patients with primary ovarian cancer stage III, randomized at the end of the upfront cytoreductive surgery for HIPEC (Intervention) with cisplatin 100mg/m2, 90 min, 41-42°C, or surgery only (standard).

Comparison will be conducted between arms to elucidate overall survival (primary outcome), recurrence–free survival, morbidity, toxicity, quality of life, and prediction markers.

The expected patient benefit is improved overall survival for 24 months considering median survival in the standard compared to the intervention arm, 49.7 and 74.2 months, respectively, and identification of prediction markers of the response to HIPEC. The implementable results are expected 2-years after fulfilled recruitment.