Stereotactic Radiation for Growing/Changing Brain Metastases With Same-Day Radiation Planning and Treatment With Margin Reduction
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Ayal A. Aizer, MD
- Study ID
- NCT07132190
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Brain Metastases From Extra-cranial Solid Tumors
- Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
- Brain Metastases, Adult
- Brain Tumor - Metastatic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV — RADIATIONLinear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV
Study Details
The goal of this study is to evaluate the feasibility and effectiveness of same-day radiation planning and treatment. The study will shorten the time interval between radiation planning (radiation mapping) and radiation treatment. The intent of this shorter time interval is to increase the likelihood that the brain metastases being treated remain fully within the high-dose radiation fields. Participants will be randomized to receive brain-directed stereotactic radiation with a 1mm margin or 0mm margin, have their simulation/radiation planning imaging on the same day that brain-directed stereotactic radiation is delivered, and have repeat simulation/radiation planning scans during the course of treatment if more than 2-3 days have elapsed since the most recent scans.
Key Dates
- Start date
- Dec 30, 2025
- Status verified
- Mar 2026
- Primary completion
- Sep 30, 2028
- Completion
- Sep 30, 2029
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 0mm PTV0mm uncertainty margin
- Active Comparator: 1mm PTV1mm uncertainty margin
Primary Outcome Measure
To assess the percentage of patients that demonstrate tumor beyond the standard planning margin (1.0mm PTV) at the time of stereotactic treatment. [ Time Frame: Diagnostic MRI to MRI on first day of treatment ]
Central Contacts
- Ayal A Aizer, MD, MHS(617) 732-7560
- Ivy B Ricca, BA(617) 582-8927
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brigham and Women's Hospital / Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 |
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