NCT06712745

Feasibility Study of Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to enhance the safety profile of SAbR in ultra-central tumors of the lung (primary or metastatic) without compromising its effectiveness.

Detailed description

This will be achieved by demonstrating the feasibility of applying adaptive radiation therapy given in PULSAR fractionation and using a 1.5T MR-guided linac system with real-time motion monitoring (Unity, Elekta). The hypothesis is that safety can be improved through: (1) better visualization of tumors, leading to less uncertainty when delineating GTVs; (2) reduced margins for setup, motion, or other sources of uncertainty; and (3) improved normal tissue healing between radiation fractions. To achieve this, we propose a personalized ultrafractionated stereotactic adaptive radiotherapy (PULSAR) delivery schedule, administering 5 fractions total, given as one fraction every 3 weeks (Fig. 3) and using MRI-guided adaptive treatment planning. This study is single arm in nature and in the feasibility phase

Conditions

• Cancer, Lung
• Metastasis

Interventions

Type	Name	Description
RADIATION	Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR)	Radiation Therapy Prescription Dose: A dose of 40-50 Gy in 5 fractions prescribed to the PTV will be used for all cases

Timeline

• Start date: 2025-09-19
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2024-12-02
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States