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临床试验/NCT00471835
NCT00471835撤回1 期

A Phase I/II Study of Hypofractionated Stereotactic Body Radiotherapy for Stage I/II Non-small Cell Lung Cancer Within the Central Lung Region and the Prognostic Impact of FDG Positron Emission Tomography

Wake Forest University Health Sciences0 个研究点开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
1 期
状态
撤回
主要终点
Maximum tolerated dose (Phase I)

研究概览

简要总结

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with stage I or stage II non-small cell lung cancer.

详细描述

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of hypofractionated stereotactic body radiotherapy (SBRT) to the central lung region (peri-mediastinum) in patients with stage I or II non-small cell lung cancer. (Phase I)
  • Determine local control and time to local progression in patients treated with this regimen. (Phase II)
  • Evaluate the ability of peak standardized uptake values (SUV) for fludeoxyglucose F 18 (FDG)-PET scan, obtained shortly after SBRT (post-treatment), to predict local control and time to progression in these patients.

Secondary

  • Evaluate the ability of maximum SUV for FDG-PET scan, obtained shortly after SBRT, to predict long-term local control and time to progression in these patients.
  • Evaluate the ability of peak SUV and max SUV for FDG-PET scan, obtained prior to SBRT, to predict local control and time to progression in these patients.
  • Determine the utility of PET/CT scan data in guiding treatment planning.
  • Determine if treatment with radiotherapy involving high biological doses with limited treatment volume using these SBRT techniques achieves acceptable treatment-related toxicity.

研究设计

研究类型
Interventional
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 120 Years(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

Maximum tolerated dose (Phase I)

Time to progression and local control at 1 and 2 years (Phase II)

次要结局

  • Patterns of failure and overall survival at 2 years
  • Toxicity
  • Measurement of pre-treatment and post-treatment PET scan standardized uptake values and correlation of this data with local control at 1 and 2 years
  • Rate of acute and late treatment-related toxicity related to specific symptoms, including gastrointestinal, cardiac, neurologic, hemorrhagic, and pulmonary symptoms

研究者

申办方类型
Other
责任方
Sponsor

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