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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
538
HIPEC with cisplatin after cytoreductive surgery
City of Hope
Duarte, California, United States
overall survival
Time frame: 1 year after last patient last visit
recurrence-free survival
Time frame: 1 year after last patient last visit
adverse events
toxicity of extra treatment compared standaard treatment
Time frame: 30 days after end of treatment
cost evaluation
cost evaluation based measured by quality adjusted life year
Time frame: 1 year after lplv
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