Phase IB/II Trial Of Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
Yale University
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.
Description
The purpose of this trial is to test a deescalated 3-fraction SBRT regimen to 45 Gy in 3 fractions for centrally located thoracic tumors in a phase II trial. This will provide prospectively collected data on the safety and efficacy of a three-fraction regimen in the previously defined "No Fly Zone" for both primary non-small cell lung cancer (NSCLC) and for lung metastases of any histology. This registration describes the design and eligibility criteria for the 36 NSCLC subjects the investigators plan to enroll. Local control, cancer-specific survival, and overall survival results from the NSC…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 cr…
Interventions
- Radiation45 Gray (Gy) regimen
Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.
Locations (6)
- Smilow Cancer Hospital Care Center at GreenwichGreenwich, Connecticut
- Smilow Cancer Hospital Care Center - GuilfordGuilford, Connecticut
- Smilow Cancer Hospital - Hamden Care CenterHamden, Connecticut
- Smilow Cancer HospitalNew Haven, Connecticut
- Smilow Cancer Hospital Care Center - TrumbullTrumbull, Connecticut
- Smilow Cancer Hospital Care Center - WaterfordWaterford, Connecticut