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

Sponsor

Case Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00255671

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors Metastatic Cancer Radiation Toxicity	Other: Questionnaire

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

76 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Prospective Study on the Short-Term Adverse Effects From Gamma Knife Radiosurgery

Study Start Date :

May 1, 2005

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

May 1, 2012

Outcome Measures

Primary Outcome Measures

Short-term adverse effects as assessed by a questionnaire [at 1 week, 1 month, and 2 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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