Status:
COMPLETED
Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma
Lead Sponsor:
Japanese Gynecologic Oncology Group
Conditions:
Epithelial Ovarian Cancer
Primary Peritoneal Cancer
Eligibility:
FEMALE
20+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare progression-free survival of conventional paclitaxel and carboplatin vs weekly paclitaxel and carboplatin in patients with newly diagnosed stage II-IV ovarian ep...
Detailed Description
This is a randomized, multicenter study. Patients are stratified according to residual disease 1 cm or less vs more than 1cm, stage II vs III vs IV, and histology (clear cell or mucinous vs. serous or...
Eligibility Criteria
Inclusion
- Histologically confirmed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer
- No prior chemotherapy
- Age: 20 and more
- Performance status: ECOG 0-3
- 1\) Absolute neutrophil count at least 1,500/mm3 2) Platelet count at least 100,000/mm3 3) Bilirubin less than 1.5mg/dL 4) SGOT less than 100 IU/l 5) Serum creatinine less than 1.5mg/dL
- Written informed consent
Exclusion
- Patients with ovarian borderline tumor
- Patients who have any evidence of the other cancer present within the last 5 years with the exception of carcinoma in situ or intramucosal cancer that is curable with local therapy
- Patients with active infection or uncontrolled diabetes
- Patients with unstable angina, or those who have had a myocardial infarction within the past 6 months, or patients with serious arrythmia that requires medication
- Patients who have a history of hypersensitivity to polyoxyethylated castor oil (Cremophor EL)
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
637 Patients enrolled
Trial Details
Trial ID
NCT00226915
Start Date
April 1 2003
End Date
June 1 2012
Last Update
February 17 2020
Active Locations (1)
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1
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan