NCT00490659已完成2 期
A Phase II Trial of Perioperative Chemotherapy (Gemcitabine and Cisplatin) and Adjuvant Chemoradiotherapy (-With Weekly Low-Dose Gemcitabine) in the Treatment of Nodes Positive NSCLC Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- 2-year overall survival
研究概览
简要总结
The purpose of this study is to test feasibility, toxicity and efficacy of two different adjuvant treatment schedules in Stage II-IIIa Non-small cell lung cancer patients with positive lymph nodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of NSCLC (any subtype). For patients entering Arm B is also allowed to confirm histopathological diagnosis of NSCLC intraoperatively during this trial.
- •Node positive (clinically or pathologically) stage II disease or Stage IIIA: T1N1 or T2N1 or T1N2 or T2N2 or T3N1 or T3 N2, according to the revision by Mountain CF of American Joint Committee on Cancer (Mountain CF 1997, Fleming ID et al. 1997). For patient entering Arm B (with N0 stage) confirmation of N1-N2 stage must be obtained from intraoperative or post-surgery pathology report.
- •Tumor amenable to curative surgical resection.
- •Patients with clinically measurable lesions will be enrolled in this study. Measurability is determined according to RECIST criteria.
- •Pathological evaluation is performed after mediastinoscopy or after surgery
- •No prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, or any other type of tumor therapy).
排除标准
- •Treatment within the last 30 days with any investigational drug.
- •Concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
- •Serious concomitant disorders (for example, heart failure, poorly controlled diabetes) at the investigator's discretion.
- •Presence of an uncontrolled, active infection requiring therapy (at the discretion of investigator.).
- •Stage IIIb or IV.
结局指标
主要结局
2-year overall survival
次要结局
- Toxicity assessment
- Assessment of feasibility of two treatment orders
- Clinical and pathological response rate to neoadjuvant chemotherapy
- Disease free survival
研究者
研究点 (1)
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