Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases

Get Involved

Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases

Study Purpose

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-rays directly to the tumor and cause less damage to normal tissue.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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 Criteria:

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01843413
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Case Comprehensive Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Samuel Chao, MD
Principal Investigator Affiliation	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Tumors Metastatic to Brain, Unspecified Adult Solid Tumor

Additional Details

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 improved with increasing doses of SRS.

(Phase II) SECONDARY OBJECTIVES:

I. To determine the risk of acute and long-term toxicity with increasing dose of SRS.

(Phase II)

II. To determine if there is increased neurocognitive toxicity with increased dose of SRS.

III. To determine the rate of radiation necrosis/steroid dependency.

IV. To determine if quality of life is affected more by tumor recurrence versus radiation necrosis.

This includes assessment of progression free survival, overall survival, local failure, and number of patients who receive bevacizumab, laser interstitial thermal therapy, or surgery for presumed radiation necrosis. OUTLINE: This is a phase I dose-escalation study followed by a phase II study. Patients undergo SRS guided by computer tomography (CT) and magnetic resonance imaging (MRI). After completion of treatment, patients are followed up at 1-2, 3, 6, 9, and 12 months, every 3 months for 2 years, and then every 4 months thereafter.

Arms & Interventions

Arms

Experimental: Treatment (SRS)

Patients undergo SRS guided by CT and MRI.

Interventions

Radiation: - stereotactic radiosurgery

Undergo SRS

Procedure: - quality-of-life assessment

Ancillary studies

Procedure: - cognitive assessment

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland, Ohio

Status

Address

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195