Phase III randomized clinical trial

Grant Details

Grantee Name:
 Dr. Berit Mosgaard
 Copenhagen University Hospital
Country: Denmark

Project Name:
 Phase III randomized clinical trial for stage III epithelial ovarian cancer -  OVHIPEC-2
Funding Year:
Project period: 4 years

Phase III randomized clinical trial for stage III epithelial ovarian cancer -  OVHIPEC-2

This clinical trial is a multi-center phase III study including 8 countries and 538 patients. This study is led by the Netherlands Cancer Institute and the funding requested is to cover the cost of pharmacovigilance.

Lay Abstract

Over 75% of the patients with epithelial ovarian cancer are diagnosed with advanced disease that has spread beyond the ovaries to the peritoneal surface (stage III-IV). Optimal treatment for advanced disease involves surgery and six cycles of intravenous chemotherapy. The overall 5-year survival is 30-40% for patients with advanced stage disease. The chance of getting recurrent disease within two years is 80%. To improve outcome, additional strategies for these patients are warranted. Supplement with hyperthermic intraperitoneal chemotherapy (HIPEC) to interval debulking surgery (IDS) improve the progression free survival and overall survival in patients with stage III ovarian cancer. The impact of HIPEC in addition to primary debulking surgery (PDS), is still uncertain.
Objective: The primary objective of this study is to evaluate the effect of HIPEC on overall survival when added to primary cytoreductive surgery in patients with FIGO stage III ovarian cancer who are eligible for primary cytoreductive surgery resulting in no residual 
Study design: An international, randomized, un-blinded, phase III trial, including 538 patients with ovarian cancer stage III for whom upfront surgery is feasible.
Intervention: PCS with HIPEC is performed with cisplatin (100mg/m2) for 90 minutes at a temperature of 41-42oC in the abdominal cavity at the end of surgery. 
Main study endpoints: Primary endpoint is overall survival. Secondary endpoints are recurrence-free survival, time to subsequent anticancer treatment, toxicity and morbidity. Time to second subsequent anticancer treatment, quality of life analysis and economic- and cost evaluation are exploratory endpoints.

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