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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255671
• Other study ID #: CASE4Z05
• Status: Completed
• Start date: May 2005
• Est. completion date: May 2012

Study information

• Verified date: July 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 2012
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Metastatic Cancer
• Nervous System Neoplasms
• Radiation Toxicity

Intervention

Other:
• Questionnaire
Patients 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term adverse effects as assessed by a questionnaire	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.	at 1 week, 1 month, and 2 months