This phase II trial studies the side effects and how well stereotactic radiation therapy works in treating patients with non-small cell lung cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03321760.
PRIMARY OBJECTIVES:
I. To determine the safety of stereotactic body radiation therapy (SABR) for the treatment of primary lung disease and N1 (hilar) node in stage T1-2a N1 lung cancer. (Safety run-in)
II. To determine 2-year local control of SABR for T1-2a N1 non-small cell lung cancer (NSCLC). (Phase II)
SECONDARY OBJECTIVES:
I. To determine overall and progression-free survival times, pattern of failures, and rates of >= grade 3 adverse events after SABR for T1-2a N1 NSCLC. (Phase II)
EXPLORATORY OBJECTIVES:
I. To perform exploratory correlative analyses on biospecimen for circulating nucleic acid biomarkers with the goal to develop a predictive marker of recurrence and for prognostic variables such as T stage, tumor volume, histological subtype, type and amount of chemotherapy (if given) in this cohort.
OUTLINE:
Patients undergo SABR 2-3 times per week for up to 6 fractions in the absence of disease progression or unacceptable toxicity. Patients receive standard of care chemotherapy at medical oncologist's discretion starting between 3-8 weeks after completion of radiation therapy.
After completion of study, patients are followed up at 1 and 3 months and then every 3 months for up to 2 years.
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorTim Lautenschlaeger
