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
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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Suvaival
During the protocol treatment then 18 months from the last day of the protocol treatment
Makoto Yasuda, M.D.
The Jikei University School of Medicine
Japan: Ministry of Health, Labor and Welfare