Status:
RECRUITING
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Tumors Metastatic to Brain
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 co...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the safety (risk of acute and long-term toxicities) of neoadjuvant radiosurgery at escalating doses followed by surgical resection of brain metastases. (Phase I) ...
Eligibility Criteria
Inclusion
- Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
- Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion \> 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS
- Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection
- Patient must have a Karnofsky performance score of ≥ 70
Exclusion
- Patient deemed medically unfit to undergo surgical resection of brain metastasis
- Prior whole brain radiotherapy
- Patient with contraindication for imaging with MRI
- Inability to participate in study activities due to physical or mental limitations
- Inability or unwillingness to return for all the required follow-up visits
- At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm
- Tumor located in the brainstem
- Imaging or cytologic evidence of leptomeningeal disease
Key Trial Info
Start Date :
July 3 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01891318
Start Date
July 3 2013
End Date
December 1 2025
Last Update
July 2 2025
Active Locations (2)
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1
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
2
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195