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

Who is this study for? Patients with centrally located lung cancer
What treatments are being studied? 45 Gray regimen
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Connecticut
Smilow Cancer Hospital Care Center at Greenwich
RECRUITING
Greenwich
Smilow Cancer Hospital Care Center - Guilford
RECRUITING
Guilford
Smilow Cancer Hospital - Hamden Care Center
RECRUITING
Hamden
Smilow Cancer Hospital
RECRUITING
New Haven
Smilow Cancer Hospital Care Center - Trumbull
RECRUITING
Trumbull
Smilow Cancer Hospital Care Center - Waterford
RECRUITING
Waterford
Contact Information
Primary
Henry S. Park, MD, MPH
henry.park@yale.edu
203-200-2100
Time Frame
Start Date: 2020-08-26
Estimated Completion Date: 2030-01
Participants
Target number of participants: 36
Treatments
Experimental: 45 Gy
Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.
Sponsors
Leads: Yale University

This content was sourced from clinicaltrials.gov