NCT00253591已完成2 期
Randomised Phase II/III Trial of Induction Chemotherapy Followed by Continuous Hyperfractionated Accelerated Radiotherapy (CHART) Versus CHART Alone in Patients With Inoperable Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 20
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as vinorelbine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation therapy together with vinorelbine and cisplatin is more effective than radiation therapy alone in treating non-small cell lung cancer.
PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy together with vinorelbine and cisplatin works and compares it to radiation therapy alone in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare the overall survival of patients with stage I-III non-small cell lung cancer treated with vinorelbine, cisplatin, and continuous hyperfractionated accelerated radiotherapy (CHART) vs CHART alone.
Secondary
- Compare the response, progression-free survival, and quality of life of patients treated with these regimens.
- Compare the toxic effect of these regimens in these patients.
- Compare the cost effectiveness of these regimens in these patients.
- Compare the local and distant control in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed stage I-III non-small cell lung cancer
- •Inoperable or patient refuses surgery
- •Disease can be encompassed within the radical radiotherapy treatment volume
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Bilirubin < 1.5 times upper limit of normal
- •Glomerular filtration rate > 60 mL/min
- •Cardiovascular
- •No uncontrolled arterial hypertension
- •No ischemic heart disease
- •FEV_1 > 50% of predicted OR
- •DLCO > 50% of predicted
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior or current malignancy that would preclude study treatment
- •Medically stable
- •No unstable diabetes
- •No infection
- •No hypercalcemia
- •PRIOR CONCURRENT THERAPY:
- •Chemotherapy
- •No prior chemotherapy
- •Radiotherapy
- •See Disease Characteristics
- •No prior radiotherapy
排除标准
- 未提供
结局指标
主要结局
Overall survival
次要结局
- Progression-free survival
- Response (complete or partial response)
- Toxicity
- Cost effectiveness
研究者
研究点 (20)
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