Actively Recruiting
Phase 3 Study Comparing Interval Surgery With or Without Heated Chemotherapy HIPEC Using Cisplatin for Advanced Stage III-IV Ovarian Cancer
Led by National Cancer Center, Korea · Updated on 2026-02-13
520
Participants Needed
10
Research Sites
156 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients with stage III-IV primary epithelial ovarian cancer. This phase III randomized controlled trial aims to compare the effects of adding hyperthermic intraperitoneal chemotherapy HIPEC with cisplatin to interval cytoreductive surgery followed by neoadjuvant chemotherapy, against surgery without HIPEC. The study is led by the National Cancer Center in Korea and seeks to understand if HIPEC improves survival outcomes for these patients. Participants will be randomly assigned to one of two groups one receiving interval cytoreductive surgery combined with HIPEC using cisplatin at a dose of 75 mgm2, and the other undergoing surgery without HIPEC. Both groups will continue with neoadjuvant chemotherapy after surgery. The study follows patients over time to assess differences between these treatments. During the trial, participants will undergo regular assessments including survival tracking, cancer progression monitoring, and evaluation of treatment side effects. Quality of life will be measured using specific questionnaires over a five-year period. Researchers will also collect data on the timing of subsequent therapies and analyze cost-effectiveness. Safety and health status will be closely monitored throughout the study, which lasts up to five years after randomization.
CONDITIONS
Brief Title
Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (FOCUS / KOV-HIPEC-04)
Research Team
M
Myong Cheol Lim, MD, Ph.D
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