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

Description

The purpose of this trial is to test a deescalated 3-fraction stereotactic body radiotherapy (SBRT) regimen to 45 Gray (Gy) in 3 fractions for centrally located thoracic tumors.

Conditions

Non-small Cell Lung Cancer

Study Overview

Study Details

Study overview

The purpose of this trial is to test a deescalated 3-fraction stereotactic body radiotherapy (SBRT) regimen to 45 Gray (Gy) in 3 fractions for centrally located thoracic tumors.

Phase IB/II Trial Of Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer

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

Condition
Non-small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

New Haven

Smilow Cancer Hospital, New Haven, Connecticut, United States, 06511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Henry S. Park, MD, MPH, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2030-01