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临床试验/NCT00346320
NCT00346320已完成不适用

A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)

NCIC Clinical Trials Group38 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2006年8月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
38
主要终点
Local tumor control rate at 2 years

研究概览

简要总结

RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that cannot be removed by surgery.

详细描述

OBJECTIVES:

Primary

  • Determine the local tumor control rate at 2 years after accelerated hypofractionated 3-dimensional, conformal radiotherapy in patients with inoperable T1-3 N0 M0 non-small cell lung cancer.

Secondary

  • Determine the toxicities of this regimen in these patients.
  • Determine the rates of regional and distant disease recurrence in these patients.
  • Determine the progression-free and overall survival of patients treated with this regimen.
  • Determine the changes in pulmonary function after treatment in these patients.
  • Assess the quality of life of patients after treatment.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Local tumor control rate at 2 years

时间窗: 2 years

Overall tumor control rate will be assessed at 6 years

次要结局

  • Toxicity(6 years)
  • Disease recurrence rates(6 years)
  • Progression-free survival(6 years)
  • Overall survival(6 years)
  • Quality of life(6 years)
  • Changes in pulmonary function(6 years)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (38)

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