Comparing radiation margins in treating brain metastases with radiosurgery
UAB 2507 - Randomized Phase II Study of Differential Margins in Single Isocenter Radiosurgery of Brain Metastases
NA · University of Alabama at Birmingham · NCT06857006
This study is testing whether using different amounts of space around brain tumors during radiation treatment can help control the tumors better and reduce side effects for patients with brain metastases.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham (other) |
| Drugs / interventions | chemotherapy, immunotherapy, Radiation |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06857006 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of two different planning target volume (PTV) margins (0 mm vs 2 mm) in the radiosurgical treatment of brain metastases measuring 4 cm or less. It aims to determine how these margins affect tumor control probability and the risk of radiation toxicity. The study will enroll patients who meet specific eligibility criteria and will utilize a composite endpoint to assess outcomes. The findings are expected to inform best practices for margin use in single isocenter radiosurgery for multiple brain metastases.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with a diagnosis of brain metastases that do not require retreatment to the same tumor.
Not a fit: Patients currently undergoing cytotoxic chemotherapy or those with pregnancy or inability to undergo MRI imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols that minimize radiation toxicity while effectively controlling brain metastases.
How similar studies have performed: While the approach of using different margins in radiosurgery is common, this specific comparison of 0 mm versus 2 mm margins in a single isocenter setting is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Male or female, aged 19 and older 3. Brain metastases diagnosis not requiring retreatment to the same tumor 4. For females of reproductive potential should undergo pregnancy testing as per UAB Radiation Oncology standard policies 5. Ability of subject or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Current use of cytotoxic chemotherapy within 3 days of treatment. There are no restrictions on the use of immunotherapy during treatment. TKIs known to be radiation sensitizers such as BRAF should be held at least 24 hours prior to treatment. 2. Inability to have MRI imaging 3. Pregnancy 4. Treatment with another investigational drug 14 days of enrollment 5. Radiosurgery planned for post-operative adjuvant cavity only. Patients with any gross residual after surgery are eligible. Patients with at least one intact metastasis may enroll but adjuvant cavity will not be evaluable. 6. At the time of Radiation Oncology consultation more than twenty targets are identified. Note that it is common that a few additional metastases may be identified during the treatment planning or peer review processes. More than twenty targets may be included if this number is found after the initial clinical review of the treatment planning MRI. 7. Tumor maximal diameter \> 4 cm. 8. Prior SBRT or SRS to a lesion planned for retreatment. Note that patients with prior whole brain radiation alone are eligible. 9. Patients with diffuse leptomeningeal tumor are not eligible. Patients with a focal dural or pachymeningeal tumor are eligible if other intra-axial tumors are planned to be treated. Similar to postoperative cavities, the pachymeningeal tumor deposit will be treated but not evaluable for the assessment of local control or toxicity. INCLUSION OF VULNERABLE PARTICIPANTS Vulnerable populations as defined by the NIH including children, prisoners, and adult subjects who lack capacity to consent to research participation are not eligible.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Principal investigator: John A Fiveash, MD — The University of Alabama at Birmingham
- Study coordinator: John Fiveash, MD
- Email: jfiveash@uabmc.edu
- Phone: 205-975-0224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Metastases, stereotactic radiosurgery, radiosurgery, edge linear accelerator, single isocenter radiosurgery