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
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (Phase I)
Volker W. Stieber, MD
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government