This phase II trial studies how well accelerated radiation therapy works in treating patients with stage II-III non-small cell lung cancer that has spread to nearby tissues and lymph nodes, and cannot be removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation treatments in slightly higher daily doses over a shorter time period may improve how lung cancer responds to treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03128008.
PRIMARY OBJECTIVES:
I. To determine the metabolic complete response rate, assessed using interim positron emission tomography (PET)-computed tomography (CT), in an accelerated fashion (2 gray [Gy]/fraction, 6 fractions/week) with concurrent chemotherapy.
SECONDARY OBJECTIVES:
I. To determine how many patients will be eligible for a radiation therapy (RT) boost after assessment with an interim PET-CT between 48 Gy and 54 Gy, delivered in an accelerated fashion (6 fractions/week) with concurrent chemotherapy.
II. To evaluate clinical outcomes including overall survival, progression-free survival, and local control with an accelerated and adaptive RT approach.
III. To correlate clinical outcomes (survival, progression-free survival, local control) with interim PET-CT responses using Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) criteria.
OUTLINE:
Patients receive standard of care chemotherapy and undergo radiation therapy for 6 fractions per week for 5-6 weeks. During weeks that have holidays, the number of fractions delivered will be at the discretion of the treating radiation oncologist.
After completion of study treatment, patients are followed up to 24 months.
Lead OrganizationDuke University Medical Center
Principal InvestigatorChristopher Kelsey
