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

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.

Condition	Intervention
Brain and Central Nervous System Tumors Cancer-Related Problem/Condition	Procedure: management of therapy complications Procedure: stereotactic radiosurgery

MedlinePlus related topics:

Brain Cancer Brain Diseases Cancer

Drug Information available for:

Somatotropin Somatropin Prolactin

U.S. FDA Resources

Study Type:	Observational

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Estimated Enrollment:	94
Study Start Date:	November 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255671

Locations


United States, Ohio
	Cleveland Clinic Taussig Cancer Center
	Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators


Study Chair:	Samuel T. Chao, MD	The Cleveland Clinic

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000447067, CASE-CCF-4Z05, CASE-CCF-8078
First Received:	November 18, 2005
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00255671
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

radiation toxicity

adult tumors metastatic to brain

adult anaplastic astrocytoma

adult anaplastic ependymoma

adult anaplastic meningioma

adult anaplastic oligodendroglioma

adult brain stem glioma

adult central nervous system germ cell tumor

adult choroid plexus tumor

adult craniopharyngioma

adult diffuse astrocytoma

adult ependymoblastoma

adult ependymoma

adult giant cell glioblastoma

adult gliosarcoma

adult medulloblastoma

adult melanocytic lesion

adult meningeal hemangiopericytoma

adult meningioma

adult myxopapillary ependymoma

adult oligodendroglioma

adult papillary meningioma

adult pineoblastoma

adult pineocytoma

adult subependymoma

adult supratentorial primitive neuroectodermal tumor (PNET)

adult grade I meningioma

adult grade II meningioma

adult grade III meningioma

mixed gliomas

Study placed in the following topic categories:

Choroid Plexus Neoplasms

Glioblastoma

Neuroectodermal Tumors, Primitive

Astrocytoma

Central Nervous System Neoplasms

Pituitary Neoplasms

Brain Diseases

Hemangiopericytoma

Recurrence

Ependymoma

Brain Neoplasms

Neuroectodermal Tumors

Craniopharyngioma

Medulloblastoma

Neuroepithelioma

Meningioma

Oligodendroglioma

Glioma

Choroid Plexus neoplasms

Gliosarcoma

Pinealoma

Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Nervous System Diseases

ClinicalTrials.gov processed this record on November 06, 2008

Sponsors and Collaborators:	Case Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00255671