Phase II Trial Exploring the Feasibility of Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving carboplatin together with docetaxel after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving carboplatin together with docetaxel works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the feasibility of adjuvant carboplatin and docetaxel in patients with resected stage I, II, or IIIA non-small cell lung cancer.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the survival patterns of patients treated with this regimen.
- Assess the patterns of recurrence in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 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
Single Arm Trial
adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
干预措施: carboplatin (Drug)
Single Arm Trial
adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
干预措施: docetaxel (Drug)
结局指标
主要结局
Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen
时间窗: 12 weeks from initiating adjuvant therapy
Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks.
次要结局
- Patterns of Recurrence in Patients Treated With This Regimen(Up to 5 years)
- Toxicity in Patients Treated With This Regimen(Day 1 of treatment to 30 days after treatment discontinuation)
- Overall Survival(The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months)
- Progression Free Survival(The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months)