Efficacy Study of Additional Intraperitoneal Chemotherapy to Treat Ovarian Cancer
Most patients with advanced ovarian cancer suffered recurrences. Therefore, adjuvant therapy is recommended for all patients with advanced ovarian cancer.
Traditionally, intravenous paclitaxel + carboplatin has been the standard adjuvant therapy.
Recently, intraperitoneal combination chemotherapy has been reported to be effective in ovarian cancer.
We attempted to evaluate the efficacy and feasibility of standard intravenous paclitaxel + carboplatin plus intraperitoneal paclitaxel chemotherapy.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 2 year progression-free survival rate. [ Time Frame: 2 Year after initial surgery ] [ Designated as safety issue: No ]
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.
- Median overall survival [ Time Frame: From entry into the study to 5 year after treatment or until half of participants are dead ] [ Designated as safety issue: No ]Median observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol
- 5 year progression-free survival rate [ Time Frame: 5 year after initial surgery ] [ Designated as safety issue: No ]The time from randomization to the time of disease progression as determined by the investigator (by clinical, radiological or pathological means) or death from any cause
- 5 year overall survival rate [ Time Frame: 5 year after initial surgery ] [ Designated as safety issue: No ]Observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol.
|Study Start Date:||May 2007|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: IP Chemotherapy
Patients with optimally debulked advanced (stage 3 or 4) epithelial ovarian cancer; IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles
Drug: IP chemotherapy
IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles
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 about 31-44months.
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919984
|Korea, Republic of|
|Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences|
|Seoul, Korea, Republic of, 139-706|
|Principal Investigator:||SANG YOUNG RYU, M.D.||KOREA CANCER CENTER HOSPITAL, KOREA INSTITUTE OF RADIOLOGICAL & MEDICAL SCIENCES|