Trial of Differential Margins in Single Isocenter Radiosurgery of Brain Metastases

NCT06857006 | Recruiting

• 2 other identifiers: IRB-300014291 (UAB2507)Robert Award
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Difference between 0mm and 2mm

  Fisher's Exact Test to determine if (per patient) uncomplicated control is improved or worsened with the addition of a 2mm PTV margin in the treatment of brain metastases with single isocenter radiosurgery.

  12 months

Secondary Outcomes (3)

• Maximum margin size of the tumor

  12 months

• Percentage of toxicity

  12 months

• Change in normal brain dosimetry

  12 months

Study Arms (2)

0mm margin

ACTIVE COMPARATOR

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.

Procedure: brain metastases radiosurgery

2mm margin

ACTIVE COMPARATOR

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.

Procedure: brain metastases radiosurgery

Interventions

brain metastases radiosurgery PROCEDURE

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.

0mm margin; 2mm margin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 19 and older
• Brain metastases diagnosis not requiring retreatment to the same tumor
• For females of reproductive potential should undergo pregnancy testing as per UAB Radiation Oncology standard policies
• Ability of subject or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• 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.
• Inability to have MRI imaging
• Pregnancy
• Treatment with another investigational drug 14 days of enrollment
• 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.
• 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.
• Tumor maximal diameter \> 4 cm.
• Prior SBRT or SRS to a lesion planned for retreatment. Note that patients with prior whole brain radiation alone are eligible.
• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

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

Birmingham, Alabama, 35249, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• John A Fiveash, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Fiveash, MD

CONTACT

205-975-0224; jfiveash@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will be blinded but the treating team will not be blinded after both plans are generated and clinically reviewed.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: April 8, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

US (1)