Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Sponsor: The Netherlands Cancer Institute
ClinicalTrials ID:NCT03772028
This clinical trial evaluates the efficacy of adding HIPEC with cisplatin to primary cytoreductive surgery in patients with FIGO stage III epithelial ovarian cancer. Eligible participants must be candidates for primary CRS with histologically confirmed stage III disease. The study aims to determine if this combination improves outcomes with acceptable morbidity compared to surgery alone.
Patient Parameters
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Program Overview
stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy
Description
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.
Eligibility Criteria
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
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