RTOG 0915 Stereotactic Body Radiation for Stage I Non-Small Cell Lung Cancer Opens for Patient Accrual
Philadelphia - RTOG 0915, "A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients with Stage I Peripheral Non-Small Cell Lung Cancer," opened to patient accrual on September 3, 2009.
Eighty-eight patients with medically inoperable, biopsy-proven early stage T1, T2 (< 5 cm) NSCLC that is clinically node negative by PET, with peripherally located tumors will be entered on the protocol. Patients will be randomly assigned to receive their SBRT in either a single fraction of 34 Gy or in four consecutive daily fractions of 12 Gy for a total dose of 48 Gy.
- Arm 1: SBRT - 34 Gy in 1 Fraction
- Arm 2: SBRT - 48 Gy in 4 Fractions (12 Gy once a day for 4 days)
The primary objective of this randomized phase II study is to determine which of the two treatment schedules to use in a subsequent phase III study as the experimental arm against the current RTOG standard SBRT treatment set by RTOG?0236. The most favorable arm will be determined by the rate of grade 3 or higher adverse events at one-year post therapy. Secondary objectives are to determine the one-year local control, overall survival, and disease-free survival rates as well as an assessment of the FDG PET SUV and pulmonary function changes that can be related to response and outcomes. The association between biomarkers and local control and radiation pneumonitis will also be evaluated.
All sites entering patients must use the superposition/convolution or Monte Carlo based dose calculation algorithms. Credentialing for SBRT and heterogeneity corrections by the Advanced Technology Consortium (ATC) is necessary prior to enrolling patients on this study. See Section 5.2 for complete information about the credentialing process.
The principal Investigator of this study is Gregory M.M. Videtic, M.D., of the Cleveland Clinic Foundation (216-444-9797, videtig@ccf.org).
The study is available at:
http://www.rtog.org/members/protocols/0915/0915.pdf
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