Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma
Recruitment status was: Active, not recruiting
|Epithelial Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer||Drug: Paclitaxel+Carboplatin||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase III Trial of Conventional Paclitaxel and Carboplatin Versus Dose Dense Weekly Paclitaxel and Carboplatin in Patients With Newly Diagnosed Stage II-IV Mullerian Carcinoma|
- Progression Free Suvaival [ Time Frame: During the protocol treatment then 18 months from the last day of the protocol treatment ]
- Overall Survival [ Time Frame: During the protocol treatment then 18 months from the last day of the protocol treatment ]
- Adverse Event [ Time Frame: During the protocol treatment then 18 months ]
- Quality of life [ Time Frame: During the protocol treatment then 18 months ]
|Study Start Date:||April 2003|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Drug: Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles
Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles
Drug: Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles
Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles
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 others). Patients are randomized to one of two treatment arms.
Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 60 minutes on day 1 for 6-9 cycles.
Arm II: Patients receive paclitaxel IV over 1 hour days 1, 8, and 15 and carboplatin IV over 60 minutes on day 1 for 6-9 cycles.
In both arms, cycles repeat 6 cycles every 21 days in the absence of disease progression or unacceptable toxicity. Additional 3 cycles are given if clinical partial or complete response after 6 cycles.
PROJECTED ACCRUAL: A total 600 patients (300 per treatment arm) will be accrued for this study within 3 years. Assuming median progression-free survivals of 16 months and 21 months and a recruitment period of 3 years this can be achieved by recruiting 600 patients designed to have 80 % detect to a difference between the two arms at the two-sided 5% level of statistical significance.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226915
|National Cancer Center Hospital|
|Chuo-ku, Tokyo, Japan|
|Study Chair:||Makoto Yasuda, M.D.||The Jikei University School of Medicine|