Primary stage III-IV epithelial ovarian cancer randomizing between interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC)
The goal of this phase III randomized controlled trial is to compare the clinical efficacy of HIPEC with cisplatin (trial arm) compared to no HIPEC (control arm) during interval cytoreductive surgery followed by neoadjuvant chemotherapy, in patients with stage III-IV primary epithelial ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
520
Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin 75mg/m2 after interval cytoreductive surgery
Chungnam National University Hospital
Sejong, Chungcheongnam-do, South Korea
NOT_YET_RECRUITINGChungnam National University Sejong Hospital
Sejong, Chungcheongnam-do, South Korea
NOT_YET_RECRUITINGIlsan CHA University Hospital
Overall survival (OS)
Time frame: From randomization to the date of death from any cause, assessed up to 5 years
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
Cancer-specific survival
Time frame: From randomization to the date of death due to ovarian cancer, assessed up to 5 years
Time to first subsequent therapy (TFST)
the interval from the last day of the last cycle of a prior regimen of chemotherapy to the first day of the first cycle of the subsequent regimen for each course of chemotherapy
Time frame: from the last day of the last cycle of a prior regimen of chemotherapy to the first day of the first cycle of the subsequent chemotherapy, 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 4 weeks
Health-related quality of life (EORTC-QLQ-C30)
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
Time frame: Over the 5 year surveillance period
Health-related quality of life (EORTC-QLQ-OV28)
The EORTC QLQ-OV28 is a specified questionnaire for patients with ovarian cancer. Participant responses to the question are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized so that scores range from 0 to 100. A lower score indicates a better outcome.
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Goyang-si, Gyeonggi-do, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
RECRUITINGAjou University Hospital
Suwon, Gyeonggi-do, South Korea
RECRUITINGPusan National University Hospital
Pusan, South Korea
NOT_YET_RECRUITINGPusan National University Yangsan Hospital
Pusan, South Korea
NOT_YET_RECRUITINGAsan Medical Center
Seoul, South Korea
NOT_YET_RECRUITINGEwha Womans University Mokdong Hospital
Seoul, South Korea
NOT_YET_RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITINGTime frame: Over the 5 year surveillance period
Health-related quality of life (EQ-5D-5L)
Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5).
Time frame: Over the 5 year surveillance period
Cost-effectiveness analysis
assessed by Quality-Adjusted Live Years (QALYs), incremental cost-effectiveness ratio (ICER)
Time frame: At time of completion of 5-year surveillance period