Status:
ACTIVE_NOT_RECRUITING
Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Tumors Metastatic to Brain
Unspecified Adult Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I/II trial studies the side effects and the best dose of stereotactic radiosurgery and to see how well it works in treating patients with large brain metastases. Radiosurgery can send x-ray...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the incidence of acute and long-term toxicities with increasing dose of stereotactic radiosurgery (SRS). (Phase I) II. To determine if local control may be improve...
Eligibility Criteria
Inclusion
- Any patient undergoing SRS for brain metastases
- Lesions to be treated under this protocol must be \> 2 cm, but =\< 4.0 cm in diameter
- Patients may have had prior therapy including:
- Whole brain radiation therapy (WBRT) \> 3 months ago
- SRS to other brain metastases
- Patients with newly diagnosed brain metastases are eligible as long as they are not planned for WBRT upfront
- Any primary is eligible with exception of small cell lung cancer, lymphoma, and germ cell histologies
- Patient must be able to provide written informed consent
Exclusion
- Patients receiving SRS to resection bed
- Planned concurrent WBRT
- Leptomeningeal metastases
- Small cell lung cancer, lymphoma, and germ cell histologies
- Inability to participate in study activities due to physical or mental limitations
- Inability or unwillingness to return for all the required follow-up visits
- Conformality index 2.0 or less cannot be achieved, or homogeneity index is \> 2.0
- Unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm
- Brainstem location is excluded from this study
Key Trial Info
Start Date :
July 2 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01843413
Start Date
July 2 2013
End Date
August 1 2025
Last Update
July 20 2025
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195