NCT00449657终止2 期
Phase II Trial of Pulsed Paclitaxel With Concurrent Radiotherapy,and Adjuvant Chemotherapy in Stage III Non-Small Cell Lung Cancer
Leo W. Jenkins Cancer Center2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2007年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Tumor response using RECIST criteria
研究概览
简要总结
This is a phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer
详细描述
OBJECTIVES Primary
- Overall survival
- Tumor response using RECIST criteria
Secondary
- Determine the toxicity of the proposed treatment in this patient population.
- Progression free survival
- Locoregional control
- Distant failure
STUDY DESIGN
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
- •Patients must have: IIIA or IIIB non-small cell lung cancer by radiographic or surgical staging, excluding: superior sulcus tumors, tumors with associated atelectasis or obstructive pneumonitis of the entire lung, and tumors with a malignant pleural effusion.
- •Patients will be included in the study based on the following criteria:
- •Patients must be older than 18 years old.
- •Patients must have a Zubrod performance status of 0 to 2
- •Patients with adequate bone marrow function
- •Patients with adequate renal function
- •Patients with adequate hepatic function
- •Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception.
- •Patients who are suitable for treatment with radical intent using concurrent chemotherapy and radiation.
- •Patients who have signed an approved informed consent and authorization permitting release of personal health information.
排除标准
- •Disease-Specific Exclusions
- •Superior sulcus tumors
- •Atelectasis or obstructive pneumonitis of the entire lung
- •Malignant pleural effusion
- •General Medical Exclusions
- •Surgical candidates
- •Patients who are pregnant at the time of diagnosis
- •Serious concomitant systemic disorders incompatible with the study
- •Inability to comply with study and/or follow-up procedures
- •Life expectancy of less than 12 weeks
- •Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
- •Patients with septicemia or severe infection.
- •Patients who have circumstances that will not permit completion of this study or the required follow-up
- •Patients with any contraindication to gemcitabine, carboplatin, or paclitaxel
结局指标
主要结局
Tumor response using RECIST criteria
时间窗: 12/31/2014
次要结局
- Locoregional control(12/31/2014)
- Distant failure(12/31/2014)
- Progression free survival(12/31/2014)
研究者
研究点 (2)
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