Multicenter Exploratory Trial of the Safety and Efficacy of Adjuvant Docetaxel and Carboplatin in Patients With Resected Non-small Cell Lung Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 12
- 主要终点
- Febrile Neutropenia
研究概览
简要总结
The purpose of this study is to determine whether it is safe to treat lung cancer patients who have undergone an attempt at curative resection with the combination of docetaxel and carboplatin.
详细描述
Patients with stage Ib - IIIa NSCLC participated in an open-label, single arm study to assess the safety and tolerability of docetaxel (75 mg/kg) and carboplatin (AUC 5.5) administered for 3 cycles after resection for curative intent. The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%. Other endpoints assessed protocol compliance and the impact of minimally invasive surgical technique.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-small cell lung cancer stage IB - IIIA, complete resection with mediastinal lymph node dissection
- •ECOG status 0-1
- •>14 and <56 days since resection
排除标准
- •Prior chemotherapy and/or radiation therapy for lung cancer
- •Peripheral neuropathy > grade 1
- •Concurrent other malignancies, other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- •Medical condition that will not permit treatment or follow up according to the protocol
- •Prior treatment with docetaxel or carboplatin
- •Hypersensitivity to polysorbate 80, platinum-containing compounds or mannitol
- •Treatment with other investigational anti-cancer drugs within 30 days of registration
- •Pregnant or nursing women
- •HIV-positive patients
研究组 & 干预措施
Treatment
Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
干预措施: Docetaxel-Carboplatin (Drug)
结局指标
主要结局
Febrile Neutropenia
时间窗: 2 months
The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of \<10%.
次要结局
未报告次要终点
研究者
Michael Mann
Director
Maestro Clinical, Inc.