Platinum-resistant recurrent epithelial ovarian cancer randomizing with or without cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (HIPEC): KOV-02R, RECOVER
The objective of this trial (KOV-HIPEC-02R) is to prove the survival benefit of HIPEC with doxorubicin and mitomycin (trial arm) compared to physician-choice chemotherapy (control arm) in patients with platinum-resistant recurrent epithelial ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
HIPEC perfusion, doxorubicin 35mg/m2 \& mitomycin 15 mg/m2, 41.5'C, 90 min.
Myong Cheol Lim
Goyang-si, Gyeonggi-do, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Korea University Anam hospital
Seoul, South Korea
Progression-free survival (PFS)
Time frame: From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years
Overall survival (OS)
Time frame: From randomization to the date of death from any cause, assessed up to 5 years
cancer-specific survival
Time frame: From randomization to the date of death due to ovarian cancer, assessed up to 5 years
Treatment-related adverse events
assessed by CTCAE ver.5.0
Time frame: From randomization up to the end of treatment plus 6 weeks
Health-related quality of life (QLQ C30)
assessed by EEuropean Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Score 30 (QLQ-C30)
Time frame: Over the 5 year surveillance period
Health-related quality of life (QLQ OV28)
assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28)
Time frame: Over the 5 year surveillance period
Health-related quality of life (EQ-5D-5L)
assessed by the 5-level EQ-5D version (EQ-5D-5L)
Time frame: Over the 5 year surveillance period
Cost-effectiveness analysis
assessed by Quality-Adjusted Live Years (QALYs)
Time frame: At time of completion of 5-year surveillance period
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