This clinical trial tests the effect of planning and starting stereotactic radiation on the same day and compares the effect of smaller or no setup margins in treating patients with a tumor that has spread to the brain (metastases) from where it first started (primary site) and has been left behind after treatment (residual) or that has come back after a period of improvement (recurrent). Stereotactic radiosurgery (SRS) or stereotactic radiotherapy (SRT) 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. It is used to treat brain tumors and other brain disorders that cannot be treated by regular surgery. Currently, standard of care treatment with SRS/SRT usually starts within 14 days of planning or radiation mapping. Shortening the time interval from planning to starting treatment may increase the likelihood that the brain metastasis being treated remain fully within the high-dose radiation treatment fields, allowing treatment without the use of large margins. Margins, small buffers added beyond the border of the tumor, are often used in radiation planning, in part, to account for uncertainty that may have resulted in changes in the location or the size of the tumor between planning and starting treatment. Larger margins expose healthy tissue to radiation which may increase injury to the underlying brain tissue (radiation necrosis). Same day planning and starting SRS/SRT may be safe, tolerable and/or effective in treating patients with residual or recurrent brain metastases. In addition, using no margin (0mm) compared to a small margin (1mm) may be an effective strategy to prevent radiation necrosis while effectively treating the brain metastases.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07132190.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's HospitalStatus: Active
Contact: Ayal Aaron Aizer
Dana-Farber Cancer InstituteStatus: Active
Contact: Ayal Aaron Aizer
PRIMARY OBJECTIVE:
I. To assess the percentage of patients that demonstrate tumor beyond the standard planning margin (1.0mm planning target volume [PTV]) at the time of stereotactic treatment.
SECONDARY OBJECTIVES:
I. To quantify local recurrence and radiation necrosis rates in patients treated with same day simulation and treatment, based on randomization to a PTV of 0mm or 1.0mm.
II. Overall survival.
III. Death due to neurologic disease progression.
IV. Performance status, assessed longitudinally.
V. Incidence and time to detection of new brain metastases.
VI. Incidence and time to development of radiation necrosis.
VII. Incidence and time to development of leptomeningeal disease.
VIII. Incidence and time to local recurrence.
IX. Incidence and time to salvage craniotomy.
X. Incidence and time to additional radiotherapeutic treatments after the initial course.
XI. Progression free survival.
XII. Incidence and time to the development of seizures.
XIII. Quality of life/symptom burden and interference.
XIV. Neurocognitive function.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo SRS/SRT with 0mm margin on 1, 5, or 6 days as per standard of care. Patients also undergo magnetic resonance imaging (MRI) throughout the study. Additionally, patients may undergo computed tomography (CT) simulation throughout the study.
ARM II: Patients undergo SRS/SRT with 1.0mm margin on 1, 5, or 6 days as per standard of care. Patients also undergo MRI throughout the study. Additionally, patients may undergo CT simulation throughout the study.
After completion of study treatment, patients are followed at 1.5, 3, 5, 7, and 9 months then every 3 months until death or withdrawal from the protocol.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorAyal Aaron Aizer
