This phase II trial studies how well positron emission tomography (PET)/computed tomography (CT) and single positron emission computed tomography (SPECT)/CT imaging works in improving radiation therapy treatment in patients with stage IIB-IIIB non-small cell lung cancer. PET/CT imaging mid-way through treatment may be able to accurately show how well radiation therapy and chemotherapy are working. SPECT/CT imaging may be able to tell which parts of the lung tissue are healthier than others. Based on the result of the imaging, treatment adjustments may be made to the radiation therapy to improve survival and decrease toxicity.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02773238.
PRIMARY OBJECTIVE:
I. To test the superiority of 2 year (yr) overall survival (OS) in the functional lung avoidance and response-adaptive dose escalation (FLARE) radiation therapy (RT) patient cohort over the 60 gray (Gy) cohort of Radiation Therapy Oncology Group (RTOG) 0617 (57% 2yr OS) for historical control.
SECONDARY OBJECTIVE:
I. Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4 grade 2 or higher pneumonitis incidence from FLARE RT compared to historical controls (non-inferiority test).
II. 1 yr local control, progression-free survival, and pulmonary function test decline.
III. Identification of baseline fludeoxyglucose (FDG) PET/CT and mid-treatment FDG PET/CT imaging biomarkers for predicting patient survival.
IV. Identification of baseline perfusion SPECT/CT imaging biomarkers for predicting grade (G)2+ pneumonitis and pulmonary function tests (PFT) decline.
V. Collection of plasma and urine samples for future correlative studies between imaging biomarkers and cytokine biomarkers of radiation response in both tumor and normal tissue.
OUTLINE: This is a dose-escalation study of radiation therapy.
Patients undergo functional avoidance radiation therapy during weeks 1-3. Patients undergo fludeoxyglucose F-18 FDG PET/CT at baseline, 3 weeks, and 3 months post-radiation therapy and undergo technetium Tc-99m albumin aggregated (99mTc-MAA) and technetium Tc-99m sulfur colloid SPECT/CT radiation therapy at baseline and 3 months post-radiation therapy. Baseline PET/CT must be performed at University of Washington Medical Center/Seattle Cancer Care Alliance and be within one month of treatment start, therefore some patients may need to repeat a baseline PET/CT if their PET/CT is from an outside institution or > 1 month old. Patients not responding to treatment at 3 weeks, will receive an increased daily radiation therapy dosage.
After completion of study treatment, patients are followed up for 2 years.
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorJing Zeng
