This phase II trial studies the effect of adaptive radiation planning in reducing side effects associated with radiation treatment and immunotherapy in patients with stage II-IV non-small cell lung cancer. Prior to radiation, patients undergo simulation, where they are positioned on the treatment table in a manner that can be reproduced each time they receive treatment in order to reach the tumor exactly at the same spot each time. However, a patient's tumor may shrink as they receive radiation, exposing healthy tissue to radiation as well. Adaptive radiation planning involves re-designing a treatment plan at set intervals. The purpose of this study is to see whether establishing set time points through adaptive radiation planning, regardless of whether the doctor notices a significant decrease in tumor size, will reduce some of the side effects associated with radiation treatment and immunotherapy.
PRIMARY OBJECTIVE: I. To evaluate whether implementing set intervals for radiation replanning reduces cardiopulmonary toxicity and preserves healthy lung and heart tissue, with the intention of establishing a new standard treatment modality. OUTLINE: Patients undergo computed tomography (CT) stimulation with or without intravenous (IV) contrast over 1.5 hours on days -15 to -1, then undergo standard of care (SOC) chemoradiation on days 1-40. Patients also undergo additional CT scan simulations without IV contrast over 20 minutes each on days 15 and 29. After completion of study, patients are followed up at 3-12 weeks, and then every 6 months for approximately 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
34
Undergo CT simulation
Given IV
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RECRUITINGRWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
RECRUITINGDetermine if adaptive radiation therapy reduces radiation induced pneumonitis rates
Will be analyzed using a one-sided z-test to determine if reduction in radiation doses to organs at risk compared will result in a lower rate of pneumonitis compared to historical controls.
Time frame: At 6 months post chemoradiation
Determine if adaptive radiation therapy reduces radiation doses to heart and lung
Will be compared to computed tomography simulation without adaptation of lung tumor volumes. The dosimetric parameters collected over the treatment period will be analyzed using linear mixed models with appropriate intra-correlation structures.
Time frame: Baseline up to day 29 of treatment
Dosimetric changes in lung, heart, and esophageal dosimetry parameters in patients treated with adaptive radiation planning
Will be compared to computed tomography simulation without adaptation of tumor volumes. The dosimetric parameters collected over the treatment period will be analyzed using linear mixed models with appropriate intra-correlation structures.
Time frame: Baseline up to day 29 of treatment
Change in toxicities, including cardiac and esophageal toxicities
Will be compared to historical controls who have not undergo adaptive re-planning at specified time points using Common Terminology Criteria for Adverse Events version 5.0.
Time frame: Baseline up to 25 months after chemoradiation
Toxicity correlation to disease-free survival (DFS)/progression-free survival (PFS)/overall survival (OS)
Will determine if toxicity correlates to DFS/PFS/OS using historical controls for comparison, estimated via Kaplan-Meier product limit and compared among different toxicity levels using a log-rank test.
Time frame: Up to 25 months after chemoradiation
Tumor volume reduction
Will determine if tumor volume reduction correlates to immunotherapy response.
Time frame: Up to 25 months after chemoradiation
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