A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 571
- 试验地点
- 151
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer.
PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer.
详细描述
OBJECTIVES:
- Compare the progression-free interval and overall survival of patients with early stage ovarian epithelial cancer treated with carboplatin and paclitaxel with or without low-dose paclitaxel.
- Assess the frequency and severity of toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Four weeks after the completion of paclitaxel and carboplatin, patients receive low-dose paclitaxel IV over 1 hour once a week for 24 weeks.
- Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Patients then undergo observation.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
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
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Carboplatin, paclitaxel, low dose paclitaxel
carboplatin, paclitaxel followed by low dose paclitaxel 4 weeks later
干预措施: paclitaxel (Drug)
Carboplatin, paclitaxel, low dose paclitaxel
carboplatin, paclitaxel followed by low dose paclitaxel 4 weeks later
干预措施: carboplatin (Drug)
Carboplatin, paclitaxel
carboplatin, paclitaxel
干预措施: carboplatin (Drug)
Carboplatin, paclitaxel
carboplatin, paclitaxel
干预措施: paclitaxel (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Up to 5 years
The percent of participants with disease recurrence within 5 years
Overall Survival
时间窗: up to 96 months
Number of deaths during study and follow up.
Number of Participants With Adverse Events Grade 3 or Greater
时间窗: Throughout study treatment lasting up to 24 weeks
Toxicities, Grade 3 or greater (CTC version 2.0) by treatment arm for all treated participants
次要结局
未报告次要终点