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Radiation Therapy
Stereotactic Radiosurgery for Brain Tumors
Phase 1
Waitlist Available
Led By Samuel Chao, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Any patient undergoing SRS for brain metastases
Lesions to be treated under this protocol must be > 2 cm, but =< 4.0 cm in diameter
Must not have
Conformality index 2.0 or less cannot be achieved, or homogeneity index is > 2.0
Brainstem location is excluded from this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study the side effects and determine the optimal dose of a type of radiation therapy called stereotactic radiosurgery for treating patients with large brain metastases. Radiosurgery targets the tumor
Who is the study for?
This trial is for patients with large brain metastases from solid tumors, excluding small cell lung cancer, lymphoma, and germ cell cancers. Participants must have lesions 2-4 cm in diameter suitable for stereotactic radiosurgery (SRS), may have had previous SRS or whole brain radiation therapy over 3 months ago, and be able to consent.
What is being tested?
The study is testing the safety and optimal dose of stereotactic radiosurgery—a precise form of radiation therapy—for treating large brain metastases. It also examines how well it works by assessing quality-of-life and cognitive functions before and after treatment.
What are the potential side effects?
Potential side effects include localized hair loss, headaches, nausea, fatigue, short-term memory issues or other cognitive changes due to targeted high-dose radiation affecting both tumor tissue and surrounding normal brain areas.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am receiving SRS treatment for brain cancer spread.
Select...
My tumor is between 2 and 4 cm in size.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My radiation treatment plan doesn't meet specific uniformity criteria.
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My cancer is not located in the brainstem.
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I am getting focused radiation therapy after tumor removal.
Select...
My cancer has spread to the lining of my brain and spinal cord.
Select...
I am scheduled for whole brain radiation therapy.
Select...
I can commit to attending all required follow-up visits.
Select...
Radiation to my optic nerve/chiasm cannot be limited to 10 Gy or less.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Incidence of adverse events as assessed by CTCAE version 4.0 (Phase II)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (SRS)Experimental Treatment3 Interventions
Patients undergo SRS guided by CT and MRI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
stereotactic radiosurgery
2011
Completed Phase 3
~1010
quality-of-life assessment
2012
Completed Phase 3
~2780
cognitive assessment
2005
Completed Phase 3
~1210
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
468 Previous Clinical Trials
33,403 Total Patients Enrolled
Samuel Chao, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
2 Previous Clinical Trials
170 Total Patients Enrolled