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Acute Side Effects in Patients Who Are Undergoing Stereotactic Radiosurgery for Brain Tumors or Other Brain Disorders

Study Purpose

RATIONALE: Learning about the side effects of stereotactic radiosurgery in patients with brain tumors or other brain disorders may help doctors plan treatment and help patients live more comfortably. PURPOSE: This clinical trial is studying the acute side effects in patients who are undergoing stereotactic radiosurgery for brain tumors or other brain disorders.

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.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Diagnosis of brain tumor or other brain disorder, including, but not limited to, 1 of the following: - Primary brain tumors.
  • - Brain metastases.
  • - Acoustic neuromas.
  • - Pituitary adenomas.
  • - Parkinson's disease.
  • - Cluster headaches.
  • - Glomus jugulare.
  • - Epilepsy.
  • - Obsessive compulsive disorder.
  • - Arteriovenous malformations.
  • - Trigeminal neuralgia.
  • - Eligible for and scheduled to undergo stereotactic radiosurgery.
PATIENT CHARACTERISTICS: Performance status.
  • - Not specified.
Life expectancy.
  • - Not specified.
Hematopoietic.
  • - Not specified.
Hepatic.
  • - Not specified.
Renal.
  • - Not specified.
Other.
  • - No physical or mental limitation that would preclude study compliance.
PRIOR CONCURRENT THERAPY: Endocrine therapy.
  • - Concurrent steroids allowed.
Radiotherapy. - No prior stereotactic radiosurgery

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.

NCT00255671
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.

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.

John Suh, 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 Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors, Metastatic Cancer, Radiation Toxicity
Additional Details

OBJECTIVES:

  • - Determine the incidence and types of acute complications in patients undergoing stereotactic radiosurgery for brain tumors or other brain disorders.
  • - Determine the time frame for development and resolution of these complications in these patients.
  • - Determine the severity of these complications in these patients.
OUTLINE: Patients undergo stereotactic radiosurgery. Patients also complete questionnaires about the side effects they experience from radiosurgery. The questionnaires are completed at baseline and at 1 week, 1 month, and 2 months after radiosurgery. PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study.

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 Clinic Taussig Cancer Center, Cleveland, Ohio

Status

Address

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195