Primary Outcome Measures:
- Maximum tolerated dose of stereotactic body radiotherapy (SBRT) as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Dose-limiting toxicity (DLT) of ≥ grade 3 as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 2-year local control rate [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Time to local progression [ Designated as safety issue: No ]
- Time to regional nodal progression [ Designated as safety issue: No ]
- Time to distant metastases [ Designated as safety issue: No ]
- Toxicity (other than DLT) of ≥ grade 3 as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Late toxicity (i.e., occurs > 1 year after the start of SBRT) of ≥ grade 3 as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
OBJECTIVES:
Primary
- To determine the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) in medically inoperable patients with centrally located stage I non-small cell lung cancer.
- To determine the efficacy of SBRT when administered at the MTD in these patients.
Secondary
- To estimate the rates of adverse events (other than dose-limiting toxicity) of ≥ grade 3 that is possibly, probably, or definitely related to treatment and that occurs within 1 year after the start of SBRT in these patients.
- To estimate the rates of late adverse events (i.e., occurs > 1 year after the start of SBRT) in these patients.
- To estimate the local control and progression-free and overall survival rates in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo stereotactic body radiotherapy every 2 days over 1½-2 weeks (total of 5 fractions) in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically.