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Alliance A071801


Clinical Trial Title

Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS for Resected Metastatic Brain Disease

Trial Status

Open to Enrollment

Start Date

October 11, 2019

Trial Type

Cancer - Adult Oncology

Specific Condition

Metastatic Brain Disease


This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.

Eligibility Criteria

Eligibility Criteria

  • Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site. Patients with or without active disease outside the nervous system are eligible (including patients with unknown primaries), as long as the pathology from the brain is consistent with a non-central nervous system primary site.
  • Three or fewer (i.e. 0 to 3) unresected brain metastases (as defined on the post-operative MRI) at the time of screening.
  • One brain metastasis must be completely (gross total resection) resected ≤30 days prior to pre-registration.
  • The resected brain metastasis must measure 2 cm or larger on the pre-operative MRI.
  • Karnofsky Performance Status of ≥60
  • Ability to complete an MRI of the head with contrast
  • The brain metastasis must be located >5mm of the optic chiasm and outside the brainstem
  • Must not have any prior whole brain radiation therapy.
  • Past radiosurgery to other lesions is allowed

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Andrew Kee, MD

Contact Name

Oncology Clinical Research



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Last Updated: Wednesday, January 27, 2021 12:56:56 PM