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
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Smilow Cancer Hospital Care Center at Greenwich Coordinator of this site? Confirm its status | Greenwich | United States | Recruiting |
| Smilow Cancer Hospital Care Center - Guilford Coordinator of this site? Confirm its status | Guilford | United States | Recruiting |
| Smilow Cancer Hospital-Hamden Care Center Coordinator of this site? Confirm its status | Hamden | United States | Recruiting |
| Smilow Cancer Hospital Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Smilow Cancer Hospital Care Center-Trumbull Coordinator of this site? Confirm its status | Trumbull | United States | Recruiting |
| Smilow Cancer Hospital Care Center - Waterford Coordinator of this site? Confirm its status | Waterford | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.