Actively Recruiting
Feasibility Study of Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung
Led by University of Texas Southwestern Medical Center · Updated on 2025-11-10
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
E
Elekta Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a personalized ultra-fractionated stereotactic ablative radiotherapy (PULSAR) approach to improve the safety of treating ultra-central lung tumors, which may be primary or metastatic cancers. The study explores whether better tumor visualization, smaller treatment margins, and improved normal tissue healing between radiation doses can enhance safety without reducing treatment effectiveness. This early phase feasibility study uses advanced MRI-guided radiation therapy techniques to precisely target tumors. Participants will receive PULSAR radiation therapy using a 1.5T MR-guided linear accelerator system with real-time motion monitoring. Treatment involves delivering a total of five radiation fractions, with one fraction given every three weeks over 2 to 5 months. The radiation dose prescribed is 40-50 Gy to the planned target volume. Treatment breaks of up to six months are allowed if needed. If a complete tumor response occurs between fractions, remaining treatments may be stopped based on the physician's decision. Treatment may also end early due to severe side effects or disease progression. During the study, participants will undergo adaptive radiation planning guided by MRI scans to monitor tumor changes and normal tissue response. Researchers will assess survival and tumor response over 4 years as primary outcomes, with tumor volume changes measured at 1 year. Safety and treatment effectiveness will be closely monitored throughout. The study is sponsored by the University of Texas Southwestern Medical Center and will follow patients from treatment through extended follow-up periods.
CONDITIONS
Brief Title
Feasibility Study of Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed diagnosis of cancer with lung tumor related to biopsied site
- Tumor size between 1.5 cm and 5 cm in maximum diameter
- Tumor fully within 2 cm central lung zone or within 1 cm of mediastinum, esophagus, or proximal bronchial tree
- Zubrod/ECOG performance status 0 to 2 within 30 days prior to registration
- Ability to tolerate MRI
- All men and women of child-bearing potential must agree to use effective contraception during and for 90 days after study participation
You will not qualify if you...
- Prior radiotherapy to the study cancer region that would overlap with study treatment fields
- Planned other local lung therapy during study, except if disease progresses
- Females of reproductive potential not using birth control, pregnant or breastfeeding, or positive pregnancy test before study entry
- Use of anti-VEGF therapy within the past year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 5 months, with possible extension up to 6 months if treatment breaks occur
Participants receive personalized ultra-fractionated stereotactic ablative radiotherapy (PULSAR) over multiple sessions with 3 to 4 weeks between each radiation fraction.
5 treatment sessions spaced approximately 3 to 4 weeks apart
Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
S
SARAH NEUFELD, MS, MBA
K
KENNETH WESTOVER, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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