Complexity Level: 2
Eligibility: This study will recruit patients 18 years or older with Karnofsky PS => 60 who have one non-CNS primary brain metastasis completely resected <= 30 days prior to registration measuring 2 cm or larger with resection cavity < 5.0 cm. At the time of screening, patients must have 3 or fewer unresected brain metastases (<4.0 cm). Patients must be able to complete an MRI of the head with contrast, have no evidence of leptomeningeal metastasis, may not have a primary germ cell tumor, small cell carcinoma, or lymphoma, and no prior whole brain radiation therapy. Past radiosurgery to other lesions is allowed, with exceptions. Brain metastasis must be located => 5 mm of the optic chiasm and outside the brainstem. No resection of more than one brain metastasis.
Objectives: The primary objective is to ascertain if time to surgical bed failure is increased with FSRS compared to SSRS in patients with resected brain metastasis. Secondary objectives include: emotional well-being at 9 months, overall survival, overall quality of life (QOL), functional independence, descriptively compare the post-treatment adverse events associated with the interventions, rates of radiation necrosis at 12 months, CNS failure patterns (local, distant brain failure, local leptomeningeal disease, widespread leptomeningeal disease), time to WBRT, emotional well-being and overall QOL in long-term survivors, time to surgical bed failure, and cognitive progression between FSRS and SSRS groups.
NCT Registration ID (from clinicaltrials.gov): NCT04114981
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: May 22, 2020 Closing Date: October 14, 2022
Chair: (Canada) Dr. Jeffrey Greenspoon, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495
