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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Undergo FDG PET/CT
Undergo Tc-99m MAA or Tc-99m DTPA
Undergo FDG PET/CT
Correlative studies
Undergo FDG PET/CT
Undergo functional avoidance radiation therapy
Undergo Tc-99m MAA or Tc-99m Undergo Tc-99m sulfur colloid SPECT/CT
Undergo Tc-99m MAA SPECT/CT
Undergo Tc-99m sulfur colloid
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
SCCA Proton Therapy Center
Seattle, Washington, United States
Overall Survival (OS) Rate
Final statistical analyses of OS will consist of Kaplan-Meier estimation.
Time frame: At 2 years
Radiation Pneumonitis Defined as Common Terminology Criteria for Adverse Events Version 4 Grade 2 or Higher Pneumonitis
Common Terminology Criteria for Adverse Events version 4, grade 2 or higher pneumonitis is defined as breathing problems after radiation treatment requiring medications for treatment (grade 2), oxygen use (grade 3), hospitalization (grade 4), or leading to death (grade 5). Clinical studies commonly report how many patients that develop pneumonitis as a result of radiation treatment, which is usually within the first 3 months after radiation.
Time frame: Up to 3 months
Local-Regional Progression as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria
Intrathoracic progression of lung tumors assessed by post-radiotherapy computed tomography. Progression will be defined by RECIST criteria. Final statistical analyses of local-regional progression cumulative incidence will consist of Fine-Gray estimation with death and distant metastasis as competing risks.
Time frame: At 1 year
Progression-free Survival (PFS)
Progression-free survival will be assessed by post-radiotherapy computed tomography. Progression will be defined by RECIST criteria. Final statistical analyses of PFS will consist of Kaplan-Meier estimation.
Time frame: 1 year
Change in Pulmonary Function-forced Expiratory Volume in 1 Second (FEV1)
Pulmonary function tests (FEV1, liters) will be performed and change over time will be evaluated.
Time frame: Baseline to 3 months post-radiation therapy
Change in Pulmonary Function (Diffusing Capacity of the Lungs for Carbon Monoxide [DLCO])
Pulmonary function tests (DLCO, % predicted) will be performed and change over time will be evaluated.
Time frame: Baseline to 3 months post-radiation therapy
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