Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT00471835
Brief Summary:
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.
Detailed Description:
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.
OUTLINE: This is a phase I dose-escalation study followed by a phase II open-label study.
* Phase I: Patients undergo hypofractionated stereotactic body radiotherapy (SBRT) 3 times within a 2-week time frame.
Cohorts of 3-6 patients receive escalating doses of hypofractionated SBRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
* Phase II: Patients undergo hypofractionated SBRT at the MTD as in phase I. In both phases, patients undergo fludeoxyglucose F 18-PET/CT scans at baseline and at 12-16 weeks after completion of SBRT.
After completion of study treatment, patients are followed periodically for 4 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Study:
NCT00471835
Study Brief:
Protocol Section:
NCT00471835