Trial of Differential Margins in Single Isocenter Radiosurgery of Brain Metastases

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06857006
Status
Recruiting
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Conditions

  • Brain Metastases

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 8, 2025
Status verified
Oct 2025
Primary completion
Jun 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology CenterBirminghamAlabama35249
John Fiveash, MD (PRINCIPAL_INVESTIGATOR)
Richard Popple, MD (SUB_INVESTIGATOR)
Christopher Willey, MD (SUB_INVESTIGATOR)
Samual Marcrom, MD (SUB_INVESTIGATOR)
Hunter Boggs, MD (SUB_INVESTIGATOR)
Christopher Dobbelbower, MD (SUB_INVESTIGATOR)
James Markert, MD (SUB_INVESTIGATOR)
Kristen Riley, MD (SUB_INVESTIGATOR)
Phillip Schmalz, MD (SUB_INVESTIGATOR)
Winfield Fisher, MD (SUB_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center· Birmingham, AL

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