NCT00003159已完成3 期
Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- 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. It is not yet known if surgery is more effective with or without preoperative chemotherapy in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying surgery and preoperative chemotherapy to see how well they work compared to surgery alone in treating patients with resectable non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare the survival of patients with resectable non-small cell lung cancer treated with surgery with or without preoperative chemotherapy.
Secondary
- Compare the quality of life of patients treated with these regimens.
- Compare pre-randomization clinical and post-surgical pathological staging in patients treated with these regimens.
- Compare resectability rates in patients treated with these regimens.
- Compare time to and site of relapse in patients treated with these regimens.
- Determine response in patients treated with preoperative chemotherapy.
- Determine the adverse effects of preoperative chemotherapy in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven non-small cell lung cancer
- •Resectable disease
- •Previously untreated disease
- •No evidence of distant metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 3,000/mm^3
- •Neutrophil count greater than 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •Not specified
- •Not specified
- •Considered fit for chemotherapy and surgical resection
- •No other disease or prior malignancy that would preclude study treatment
- •No active infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent prophylactic colony-stimulating factors (except for secondary prophylaxis)
- •No concurrent immunotherapy
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •No concurrent hormonal agents, except corticosteroids
- •Radiotherapy:
- •Not specified
- •Not specified
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Survival
次要结局
- Resectability rates
- Time to and site of relapse
- Quality of life as measured by SF-36 questionnaire at baseline, 6 months, 12 months, and then annually thereafter
- Adverse effects of chemotherapy
- Extent of surgery
- Tumor response to chemotherapy
- Clinical and post-surgery pathological staging at pre-randomization
研究者
研究点 (2)
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