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

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06712745
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

  • Cancer, Lung
  • Metastasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 19, 2025
Status verified
May 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Feasibility
    Patients treated with PULSAR will undergo treatment over a total duration of 2-5 months with 3-4 weeks between each fraction. PULSAR treatments completed within 6 months will be acceptable if treatment breaks are required. In the event of a complete response between fractions, remaining fractions will be withheld at the discretion of the treating physician. Treatment may also be terminated for selected grade 3 or higher AEs. Treatment may also be terminated for regional or systemic progression detected during the PULSAR treatment interval.

Primary Outcome Measure

Efficacy- Survivability and response [ Time Frame: 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
SARAH NEUFELD SUPERVISOR OF CLINICAL RESEARCH, MS, MBA
214 648 1836
KENNETH WESTOVER, MD, PhD (PRINCIPAL_INVESTIGATOR)

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