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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 637
- 试验地点
- 1
- 主要终点
- Progression Free Suvaival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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)
研究组 & 干预措施
1
Drug: Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles
干预措施: Paclitaxel+Carboplatin (Drug)
2
Drug: Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles
干预措施: Paclitaxel+Carboplatin (Drug)
结局指标
主要结局
Progression Free Suvaival
时间窗: During the protocol treatment then 18 months from the last day of the protocol treatment
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
次要结局
- QOL(During the protocol treatment then 18 months)
- Adverse Event(During the protocol treatment then 18 months)
- Overall Survival(During the protocol treatment then 18 months from the last day of the protocol treatment)