At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 36 target
Drug / intervention
radiosurgery +2 moreradiation
Likely dose
Not stated in record
Key inclusion· 5
- ✓Prior histologic diagnosis of cancer excluding small cell lung cancer, lymphoma, and germ cell histologies
- ✓MRI evidence of 1-4 brain metastases with at least one lesion >20mm and ≤50mm suitable for SRS and gross total resection
- ✓All other brain metastases appropriate for SRS
- ✓Prior SRS to lesions other than the one planned for neoadjuvant SRS and resection allowed
Key exclusion· 8
- ✕Medically unfit to undergo surgical resection of brain metastasis
- ✕Prior whole brain radiotherapy
- ✕Contraindication for MRI imaging
- ✕Inability to participate in study activities due to physical or mental limitations
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
In Brief
A Phase 2 clinical trial evaluating radiosurgery, therapeutic conventional surgery, and 1 other intervention for Tumors Metastatic to Brain. Currently recruiting, targeting 36 participants across 2 sites.
Detailed Summary
This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTumors Metastatic to Brain
CountriesUnited States
Collaborators--
Timeline
Phase 2Recruiting
20142015201620172018201920202021202220232024202520262027
First PostedJul 2013
Enrollment StartJul 2013
TodayJul 2026
Primary CompletionSep 2026
First PostedJul 3, 2013
Enrollment StartJul 3, 2013
Primary CompletionSep 1, 2026
TodayJul 2, 2026
Enrollment to primary: 13.2 yearsPosted 13.0 years agoPrimary completion in 2 months
Interventions
radiosurgeryradiation
Undergo radiosurgery
therapeutic conventional surgeryprocedure
Undergo surgical resection
quality-of-life assessmentprocedure
Ancillary studies