Phase II Clinical Trial of Intravenous Paclitaxel and Carboplatin Plus Intraperitoneal Paclitaxel as an Adjuvant Chemotherapy in Patients With Optimally Debulked Advanced Epithelial Ovarian Carcinoma
Epithelial ovarian cancer is the leading cause of death from gynecologic malignancies
worldwide. The recommended treatment includes primary surgery for diagnosis, staging, and
cytoreduction, followed by chemotherapy. Epithelial ovarian cancer is more sensitive to
cytotoxic drugs than other solid tumors, most patients with advanced ovarian cancer are
recommended treatment with postoperative adjuvant chemotherapy. The recommended initial
chemotherapy is generally platinum and taxane combination given by intravenous infusion
every 3 weeks for 6 courses. This treatment resulted in complete remission in about 50% of
ovarian cancer patients and pathologic complete response in 25~30% of patients.
However most patients with advanced ovarian cancer suffered recurrences after primary
treatment, median progression free survival is 15.5-22months, and median overall survival is
As residual ovarian cancer after surgery and initial recurrences are primarily confined to
the abdomen, intraperitoneal administration of chemotherapy was proposed several decades
ago. In 2006, Armstrong, et al., reported improvement of overall survival in ovarian cancer
patient with optimal surgical debulking followed intraperitoneal paclitaxel + cisplatin
chemotherapy. The National Cancer Institute (NCI) of the United States recommended to
consider intraperitoneal chemotherapy in optimally debulking patients.
In Korea, however, there are few studies about postoperative adjuvant intraperitoneal
chemotherapy in optimally debulked (residual mass <1cm) advanced ovarian cancer patients.
Therefore the investigators tend to evaluate the efficacy and feasibility of postoperative
adjuvant intraperitoneal chemotherapy. (standard intravenous paclitaxel+carboplatin plus
intraperitoneal paclitaxel chemotherapy)
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
2 year progression-free survival rate.
The time from randomization to the time of disease progression as determined by the investigator or death from any cause. Progression is diagnosed by imaging or serial tumor marker elevation.
2 Year after initial surgery
SANG YOUNG RYU, M.D.
KOREA CANCER CENTER HOSPITAL, KOREA INSTITUTE OF RADIOLOGICAL & MEDICAL SCIENCES
South Korea: Institutional Review Board
KCCH GY 3001