NCT07132190RecruitingPhase 2
Stereotactic Radiation for Growing/Changing Brain Metastases With Same-Day Radiation Planning and Treatment With Margin Reduction
A Double-Blind Phase II Randomized Study of Adaptively Delivered LINAC-Based Stereotactic Radiation for Volatile Brain Metastases With Same-Day Planning and Margin Reduction
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 4 Aug 2025
- Start date
- 30 Dec 2025
- Primary completion date
- Sept 2028
- Lead sponsor
- Ayal A. Aizer, MD
- Diseases
- Lung cancer
- NCT number
- NCT07132190
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 30 Dec 2025 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants with end stage renal disease
- Participants with widespread, definitive leptomeningeal disease
Other
- Participants who cannot tolerate a brain MRI
- Patients who cannot receive gadolinium
- Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study as well
Who the study is looking for
- Participants must have a biopsy proven solid malignancy with at least one intact, residual or recurrent, intracranial lesion radiographically consistent with or pathologically proven to be a brain metastasis meeting one of the following criteria:
- Growth of 1.0mm per week or more, on average, based on the two most recent brain MRIs preceding study enrollment
- Abutment, to within 1.0cm, of a region of intracranial edema
- Proximity (within 5.0cm) to a surgical cavity created within 30 days of enrollment
- Proximity (within 5.0cm) to another source of physical displacement
- Age of at least 18 years
- Karnofsky performance status of at least 60
- Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and/or study PI
- Ability to understand and the willingness to sign a written informed consent document by either ink on paper or a DF/HCC approved eConsent medium
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital / Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.