Recruiting
Phase 1
Phase 2

Stereotactic Body Radiotherapy

Sponsor:

Yale University

Code:

NCT04210492

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

45 Gray (Gy) regimen

Study Details

Brief summary:

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 ID

NCT04210492

Start date

Aug 26, 2020

Status verified date

Jun, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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.
2. ECOG Performance Status of 0-2
3. Age > 18
4. Patients must sign a study-specific consent form.

Exclusion Criteria:

1. Prior history of radiotherapy near target lesion resulting in overlapping treatment fields. Previously irradiated will be defined as OAR structures receiving the following doses (in <3Gy 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 > 45Gy
  • Brainstem previously irradiated to > 50 Gy
  • Lung previously irradiated with prior V20Gy > 35%
2. Active systemic, pulmonary, or pericardial infection
3. Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
4. Pregnant or lactating
5. Any other medical condition or reason that, in the opinion of the investigator, would preclude study participation

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 45 Gy

Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.

Interventions

45 Gray (Gy) regimen

Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.

Primary outcome measure

  • Safety of the stereotactic body radiotherapy regimen (SBRT) [ Time Frame: From administration of SBRT up to 2 years post-SBRT ]
  • local control (LC) of 3-fraction stereotactic body radiotherapy [ Time Frame: Up to 10 years post-enrollment. ]

Central Contacts and Locations

Central contacts

Henry S. Park, MD, MPH

203-200-2100henry.park@yale.edu

Locations

Smilow Cancer Hospital Care Center at Greenwich

Recruiting

Greenwich, Connecticut, United States, 06830

Contacts

Smilow Cancer Hospital Care Center - Guilford

Recruiting

Guilford, Connecticut, United States, 06437

Contacts

Smilow Cancer Hospital - Hamden Care Center

Recruiting

Hamden, Connecticut, United States, 06518

Contacts

Smilow Cancer Hospital

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Smilow Cancer Hospital Care Center - Trumbull

Recruiting

Trumbull, Connecticut, United States, 06611

Contacts

Smilow Cancer Hospital Care Center - Waterford

Recruiting

Waterford, Connecticut, United States, 06385

Contacts

More Information

Sponsor

Yale University

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-17.