This clinical trial compares stereotactic radiosurgery (SRS) using a 0mm margin treatment approach to SRS using a 2mm margin treatment approach for treating solid tumors that have spread to the brain (brain metastases). SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SRS using a 0mm margin treatment approach targets only the tumor while SRS using a 2mm margin treatment approach targets the tumor and also includes a small area surrounding the tumor. In the United States, there is no established standard margin for SRS. This trial may help determine whether one of these SRS treatment approaches is safer and/or more effective in treating patients with brain metastases than the other.
Additional locations may be listed on ClinicalTrials.gov for NCT06857006.
Locations matching your search criteria
United States
Alabama
Birmingham
University of Alabama at Birmingham Cancer CenterStatus: Active
Contact: John B. Fiveash
Phone: 205-975-0224
PRIMARY OBJECTIVE:
I. To determine if a 0 mm or a 2 mm margin for brain metastases radiosurgery has a higher rate of uncomplicated tumor control (per patient).
SECONDARY OBJECTIVES:
I. To determine if a 2 mm margin for brain metastases radiosurgery has a higher rate of local tumor control (TCP) compared to 0 mm margin using Response Assessment in Neuro-Oncology (RANO) assessments of individual tumors.
II. To determine if a 2 mm margin for brain metastases radiosurgery has a higher rate of severe complications (per patient and per tumor) compared to 0 mm margin.
III. To determine if a 0 mm or a 2 mm margin for brain metastases radiosurgery has a higher rate of uncomplicated tumor control (per tumor).
IV. To compare the rate of adverse events (per patient) for patients receiving radiosurgery with 0 mm versus 2 mm margin.
V. To compare the rate of re-biopsy post radiosurgery (per patient) for patients receiving radiosurgery with 0 mm versus 2 mm margin.
VI. To assess potential differences in quality of life for patients receiving radiosurgery with 0 mm versus 2 mm margin.
VII. To quantify the extent of worse normal brain radiation exposure with a 2 mm margin compared to a 0 mm margin.
VIII. To define the extent of worse normal brain radiation exposure with a 2 mm margin compared to a 0 mm margin.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo SRS with a 0mm margin over 1-3 fractions. Patients also undergo MRI throughout the trial.
ARM II: Patients undergo SRS with a 2mm margin over 1-3 fractions. Patients also undergo MRI throughout the trial.
After completion of study treatment, patients are followed up at days 30, 90, 180, 270, and 365.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Alabama at Birmingham Cancer Center
Principal InvestigatorJohn B. Fiveash
