Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer

Recruitment & Eligibility

Inclusion Criteria

Lung tumors will be ≤ 5 cm and centrally located, meaning any portion of gross tumor volume located within 2 cm of (but not abutting) the proximal bronchial tree (trachea, carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi), or within 2 cm of (whether abutting or not) major vessels, esophagus, or heart (based on RTOG and MD Anderson Cancer Center definitions 33,34). Multiple concurrent isocenters are allowed if at least one tumor meets the above criteria, and if all dose constraints for the plan summation can be met. These concurrent tumors other than study target lesion can be treated as per SOC and does not necessarily have to meet the above size limit. The PI will review and prospectively approve any lesions abutting these organs
ECOG Performance Status of 0-2
Age > 18
Patients must sign a study-specific consent form.

Exclusion Criteria

prior history of radiotherapy near target lesion resulting in overlapping treatment fields. Previously irradiated will be defined as organ at risk (OAR) structures in the receiving the following doses ( in <3 Gray (Gy) per fraction): Spinal cord previously irradiated to > 40 Gy, Brachial plexus previously irradiated to > 50 Gy, Small intestine, large intestine, or stomach previously irradiated to > 45 Gy, Brainstem previously irradiated to > 50 Gy, Lung previously irradiated with prior V20Gy > 35%.
No active systemic, pulmonary, or pericardial infection
No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment
May not be pregnant or lactating
No other medical condition or reason that, in the opinion of the investigator, would preclude study participation

Study & Design

Arm && Interventions

Group	Intervention	Description
45 Gy	45 Gray (Gy) regimen	Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.

Primary Outcome Measures

Name	Time	Method
Safety of the stereotactic body radiotherapy regimen (SBRT)	From administration of SBRT up to 2 years post-SBRT	Safety will be assessed by acute (defined as within 90 days of stereotactic body radiotherapy (SBRT)) and late (from 91 days through 2 years post-SBRT) toxicities. Toxicities are based on (Common Terminology Criteria for adverse events) CTCAE v. 5 criteria
local control (LC) of 3-fraction stereotactic body radiotherapy	Up to 10 years post-enrollment.	The absence of primary tumor failure. Primary tumor failure is defined as Increase in tumor dimension of 20%.

Secondary Outcome Measures

Name	Time	Method
lobar control	Up to 10 years post-enrollment.	Absence of primary tumor failure or involved lobe failure or both.
overall survival	Up to 10 years post-enrollment.
progression-free survival	Up to 10 years post-enrollment.
regional control	Up to 10 years post-enrollment.	Absence of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably computer tomography scans) within the lung, bronchial hilum, or the mediastinum.
distant control	Up to 10 years post-enrollment.

Recruitment & Eligibility