A Phase II Randomized Study of 2 Stereotactic Body Radiation Therapy (SBRT) Regimens for Medically Inoperable Patients With Node Negative, Peripheral Non-Small Cell Lung Cancer
- To compare the incidence of toxicity with two established stereotactic body
radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II
non-small cell lung cancer.
- To compare quality of life, patterns of failure, disease-free survival, and overall
survival of these patients after treatment with one of two established SBRT regimens.
- To correlate outcomes and toxicities with imaging and patient and tumor biomarkers.
OUTLINE: Patients are stratified according to Karnofsky performance status and treatment
center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
- Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires
Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA
After completion of study treatment, patients are followed for 5 years.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of RTOG grade 3 or higher toxicity
Anurag K. Singh, MD
Roswell Park Cancer Institute
United States: Institutional Review Board
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Cleveland Clinic||Cleveland, Ohio 44195|