The Phase II Study of Intraoperative Hyperthermic Intraperitoneal Chemotherapy Followed by Intravenous Chemotherapy in Patients With Ovarian Cancer
If a patient is allocated to operation to remove ovarian cancer and metastatic disease in
the abdomen, this trial could be considered. Before operation, laboratory test results,
image result, patient's medical history, and baseline quality of life will be checked and
When optimal cytoreduction (residual tumor<1cm) is attained, this HIPEC (hyperthermic
intraperitoneal chemotherapy) could be considered. For the primary advanced epithelial
ovarian cancer, HIPEC will be performed at random. For the recurrent ovarian cancer, HIPEC
will be performed after completion of cytoreductive procedures. Usually, HIPEC takes one and
half hours after cytoreductive surgery.
After cytoreductive surgery followed by HIPEC, adjuvant chemotherapy will be added. The
cycle of chemotherapy will be determined according to the patients' clinical outcomes. The
laboratory test results, image result, patient's medical history, and baseline quality of
life will be checked after the operation, during chemotherapy, and after chemotherapy.
Cytoreduction: an operation to remove ovarian cancer and its metastatic disease
There will be an interim analysis when 50% of patients are enrolled.
At the interim analysis, a statistical test will be performed. The nominal significance
levels will be determined later. The exact nominal significance level will be determined
based on the exact number of events at the time of the interim analysis. The Stopping
boundaries will be calculated using an O'Brien-Fleming error spending function
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Progression free survival
To assess progression free survival rate during 2 years after Intraoperative Hyperthermic Intraperitoneal Chemotherapy followed by Intravenous Chemotherapy in Patients with Ovarian Cancer.
Sang-Yoon Park, MD, Ph.D.
National Cancer Center in Korea
Korea: Institutional Review Board