Deescalated Stereotactic Body Radiotherapy for Lung Cancer
Phase IB/II Trial Of Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
This study is testing a new way of giving radiation therapy to see if it safely helps people with centrally located lung tumors feel better and live longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Drugs / interventions | radiation |
| Locations | 6 sites (Greenwich, Connecticut and 5 other locations) |
| Trial ID | NCT04210492 on ClinicalTrials.gov |
What this trial studies
This trial tests a deescalated regimen of stereotactic body radiotherapy (SBRT) delivering 45 Gray (Gy) in 3 fractions for centrally located lung tumors. It aims to gather data on the safety and efficacy of this approach for patients with non-small cell lung cancer (NSCLC) and lung metastases. The study will compare outcomes such as local control and survival rates to historical controls while also assessing quality of life and radiation side effects. A total of 36 NSCLC patients will be enrolled to evaluate these parameters.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with centrally located lung tumors measuring 5 cm or less and an ECOG performance status of 0-2.
Not a fit: Patients with tumors larger than 5 cm or those with poor performance status (ECOG > 2) may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and less burdensome treatment option for patients with centrally located lung cancer.
How similar studies have performed: Other studies have shown promising results with similar SBRT approaches, but this specific deescalated regimen is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Greenwich, Connecticut and 5 other locations
- Smilow Cancer Hospital Care Center at Greenwich — Greenwich, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital Care Center - Guilford — Guilford, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital - Hamden Care Center — Hamden, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital — New Haven, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital Care Center - Trumbull — Trumbull, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Henry S. Park, MD, MPH — Yale University
- Study coordinator: Henry S. Park, MD, MPH
- Email: henry.park@yale.edu
- Phone: 203-200-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.