This randomized phase III trial studies accelerated hypofractionated image-guided radiation therapy (IGRT) compared to standard radiation therapy in treating patients with non-small cell lung cancer that is stage II-III or has come back and poor performance status. Accelerated hypofractionated IGRT uses frequent imaging and other techniques to locate the tumor before treatment and to deliver a large radiation dose to the tumor while avoiding healthy tissue. This may decrease the chance for side effects. The higher dose technique may also work better to kill tumor cells. The more standard method uses a lower dose of radiation over a longer period of time without frequent imaging. It is not yet known whether IGRT is more effective and safer than standard radiation therapy in treating non-small cell lung cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01459497.
PRIMARY OBJECTIVES:
I. To compare the efficacy by overall survival of standard radiation versus accelerated, hypofractionated, image-guided conformal radiotherapy in treatment of stage II-III or recurrent non-small cell lung cancer (NSCLC) in patients with poor performance status.
SECONDARY OBJECTIVES:
I. To compare toxicity, time to local progression, disease-free survival, quality of life, cost effectiveness, and quality adjusted life of two radiotherapy treatment regimens in patients with stage II-III or recurrent NSCLC and poor performance status.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo accelerated, hypofractionated, image-guided adaptive radiation therapy once daily (QD), 5 days a week for 3 weeks (15 fractions).
ARM B: Patients undergo standard radiation therapy QD, 5 days a week for 6 weeks (30-33 fractions).
After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorRobert D. Timmerman
