OVHIPEC-2
Research type
Research Study
Full title
Phase III randomized clinical trial for stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy
IRAS ID
1010654
Contact name
Reyhaneh Sadegh Zadeh
Contact email
Sponsor organisation
The Netherlands Cancer Institute - Antoni Van Leeuwenhoek
Eudract number
2018-003346-17
ISRCTN Number
ISRCTN78284158
Clinicaltrials.gov Identifier
Research summary
This trial is for patients with FIGO stage III epithelial ovarian cancer who are eligible for primary cytoreductive surgery. Patients will receive primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy.
Hyperthermic intraperitoneal chemotherapy (HIPEC) is heated chemotherapy and the use of temperatures of 41-42°C. Heated chemotherapy increases the penetration of chemotherapy administered in the abdominal cavity.
A previous study (OVHIPEC-1) showed that combining hyperthermic intraperitoneal chemotherapy (HIPEC) with interval cytoreductive surgery significantly improves recurrence-free and overall survival for patients. A survival benefit of nearly one year was shown in patients who underwent HIPEC. Though patients in OVHIPEC-1 were ineligible for primary cytoreductive surgery due to extensive intra-abdominal disease. So now with OVHIPEC-2, the evaluation of HIPEC + primary cytoreductive surgery to reduce residual disease and increase overall survival is being assessed.
Follow-up visits will be scheduled every 3 months in the first two years and every six months during years 3-5.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0412
Date of REC Opinion
28 Jan 2025
REC opinion
Further Information Favourable Opinion