Phase III Randomized Trial of HIPEC in Primary Stage Three & Four Primary Ovarian Cancer After Interval Cytoreductive Surgery (FOCUS, KOV-04)
Primary stage III-IV epithelial ovarian cancer randomizing between interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC)
• Signed and written informed consent,
• Patients ≥18, \<80 years old,
• Diagnosed with histologically confirmed FIGO stage III-IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer treated with three cycles of neoadjuvant chemotherapy,
• Treated with interval complete cytoreduction, or cytoreduction with no more than 2.5 mm depth of residual disease,
• A life expectancy \> 3 months as clinically judged,
• Adequate organ function for cytoreductive surgery and HIPEC,
• Women who are medically unable to conceive or who are of childbearing potential, agree to follow contraceptive guidelines during treatment and,
• Patients can also consent to the provision of clinical information for secondary use, such as future biomedical research. However, in the future, subjects can participate in the main trial even if they do not intend to participate in sharing clinical information.