Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
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.
Procedure: computed tomography
Procedure: positron emission tomography
Radiation: stereotactic body radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Maximum tolerated dose (Phase I) [ Designated as safety issue: Yes ]
- Time to progression and local control at 1 and 2 years (Phase II) [ Designated as safety issue: No ]
- Rate of acute and late treatment-related toxicity related to specific symptoms, including gastrointestinal, cardiac, neurologic, hemorrhagic, and pulmonary symptoms [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Patterns of failure and overall survival at 2 years [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471835
|Study Chair:||Volker W. Stieber, MD||Comprehensive Cancer Center of Wake Forest University|