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 epithelial, primary peritoneal, or fallopian tube cancer.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
637
Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles
Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Progression Free Suvaival
From the registration date, the earliest observed event from any of the following events 1. Death from any cause death date 2. The date of the first diagnostic imaging examination that confirmed exacerbation and recurrence. Clinical exacerbation diagnosis date if not based on diagnostic imaging 3. If none of the above events are observed, the most recent outpatient consultation date / in hospital
Time frame: During the protocol treatment then 18 months from the last day of the protocol treatment
Overall Survival
The period from the registration date to the date of death due to any cause. In the case of survivors, the final surviving confirmation date will be censored. In the case of untraceable cases, the last surviving confirmation date before tracking becomes impossible will be censored.
Time frame: During the protocol treatment then 18 months from the last day of the protocol treatment
QOL
QOL assessed by FACT-Taxane(Version 4A)
Time frame: During the protocol treatment then 18 months
Adverse Event
Adverse Event assessed by CTC(Version 2.0 Japanese version)
Time frame: During the protocol treatment then 18 months
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