Status:
TERMINATED
Efficacy Study of Additional Intraperitoneal Chemotherapy to Treat Ovarian Cancer
Lead Sponsor:
Korea Cancer Center Hospital
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
20-75 years
Phase:
PHASE2
Brief Summary
Most patients with advanced ovarian cancer suffered recurrences. Therefore, adjuvant therapy is recommended for all patients with advanced ovarian cancer. Traditionally, intravenous paclitaxel + carb...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age \>=20 and \<=75
- Histologically confirmed epithelial ovarian cancer, primary peritoneal carcinoma, tubal cancer
- Stage 3 or 4
- WBC \>= 3500/mm3, ANC \>= 1500/mm3, platelet \>= 100000/mm3, hemoglobin \>= 10 g/dl
- Serum creatinine \<= upper normal limit \* 1.25
- Total bilirubin \<= 1.5mg/mm3, ALT/AST \<= upper normal limit \* 3, ALP \<= upper normal limit \* 3
- Adequate compliance and geographical closeness which make adequate follow-up possible
- GOG performance status 0-2
- Anticipated survival \>= 3 months
- Who agreed to participate in this study and signed on informed consent form
- Exclusion criteria:
- History of chemotherapy or radiotherapy on abdomen/pelvis area
- Pleural/pericardial effusion, ascites causing respiratory difficulties \>= NCI-CTCAE grade 2
- History of other cancers within 5 years
- History of unapproved therapy within 30 days before enrollment
- Other serious diseases which could threat the safety of participants or impair the ability of participants to complete the participation.
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00919984
Start Date
May 1 2007
End Date
October 1 2010
Last Update
May 9 2014
Active Locations (1)
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1
Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences
Seoul, South Korea, 139-706