Recruiting

Radiosurgery

Sponsor:

University of Alabama at Birmingham

Code:

NCT06857006

Conditions

Brain Metastases

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

brain metastases radiosurgery

Study Details

Brief summary:

Radiosurgery is the use of a focal high dose of radiation therapy to ablate or kill a tumor. This trial will enroll patients with brain metastases 4 cm or less in greatest diameter and will compare 0mm margin to a 2mm margin for treatment.

Conditions

Brain Metastases

Study ID

NCT06857006

Start date

Apr 8, 2025

Status verified date

Jul, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 0mm margin

For each patient two radiation treatment plans will be created. One will have 0 mm margin for the planning target volume.

Tumors will be prescribed based upon the maximum diameter of the largest tumor and location at the discretion of the treating radiation oncologist with the following guidance:

< 2.0 cm diameter 16-20 Gy 2.0-4.0 cm diameter 3 fractions of 9 Gy for total 27 Gy.

active comparator: 2mm margin

For each patient two radiation treatment plans will be created. One will be 2 mm margin for the planning target volume.

Tumors will be prescribed based upon the maximum diameter of the largest tumor and location at the discretion of the treating radiation oncologist with the following guidance:

< 2.0 cm diameter 16-20 Gy 2.0-4.0 cm diameter 3 fractions of 9 Gy for total 27 Gy.

Interventions

brain metastases radiosurgery

Radiosurgery is the use of a focal high dose of radiation therapy to ablate or kill a tumor. This trial will enroll patients with brain metastases 4 cm or less in greatest diameter and will compare 0mm margin to a 2mm margin for treatment.

Primary outcome measure

  • Difference between 0mm and 2mm [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center

Recruiting

Birmingham, Alabama, United States, 35249

Principal Investigator:

John Fiveash, MD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • Brain Metastases
  • stereotactic radiosurgery (SRS)
  • radiosurgery (RS)
  • edge linear accelerator
  • single isocenter radiosurgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-07-30.