To determine if the time to local failure is improved with FSRS compared to SRS in patients with intact (i.e., unresected) brain metastases
This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. 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. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.
Pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration: Non-small cell lung cancer Melanoma Breast cancer Renal cell carcinoma Gastrointestinal cancer If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest/abdomen/pelvis, positron emission tomography [PET]/CT, etc.) is required Patients must have at least 1 and up to 8 total intact brain metastases detected on a contrast-enhanced MRI performed = 21 days prior to registration At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion with a maximum diameter as measured on any orthogonal plane (axial, sagittal, coronal) of >/= 1.0 cm and = 3.0 cm All brain metastases must be located outside of the brainstem and >/= 5 mm from the optic nerves or optic chiasm and & =3.0 cm in maximum dimension
Protocol Number: 24-2477
More information available at ClinicalTrials.gov: NCT06500455
Principal Investigator