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NCT04210492RecruitingPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 17 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
36 (estimated)
First submitted
10 Dec 2019
Start date
26 Aug 2020
Primary completion date
Jan 2030
Lead sponsor
Yale University
Diseases
Lung cancer
NCT number
NCT04210492

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 36
  • From 26 Aug 2020 to the primary completion date, Jan 2030
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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%

Other illness

  • Active systemic, pulmonary, or pericardial infection
  • Any other medical condition or reason that, in the opinion of the investigator, would preclude study participation

Other

  • Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • Pregnant or lactating

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Smilow Cancer Hospital Care Center at Greenwich
Coordinator of this site? Confirm its status
GreenwichUnited StatesRecruiting
Smilow Cancer Hospital Care Center - Guilford
Coordinator of this site? Confirm its status
GuilfordUnited StatesRecruiting
Smilow Cancer Hospital-Hamden Care Center
Coordinator of this site? Confirm its status
HamdenUnited StatesRecruiting
Smilow Cancer Hospital
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting
Smilow Cancer Hospital Care Center-Trumbull
Coordinator of this site? Confirm its status
TrumbullUnited StatesRecruiting
Smilow Cancer Hospital Care Center - Waterford
Coordinator of this site? Confirm its status
WaterfordUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.