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临床试验/NCT00253591
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

Medical Research Council40 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2005年6月最近更新:
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
40
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

入选标准

  • 未提供

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

申办方类型
Other Gov

研究点 (40)

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