Clinical trial NCT00255671: Acute Side Effects in Patients Who Are Undergoing Stereotactic Radiosurgery for Brain Tumors or Other Brain Disorders
Official title: Prospective Study on the Short-Term Adverse Effects From Gamma Knife Radiosurgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain and Central Nervous System Tumors
Metastatic Cancer
Radiation Toxicity
Keywords: radiation toxicity
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
adult mixed glioma
recurrent adult brain tumor
adult pilocytic astrocytoma
adult glioblastoma
ACTH-producing pituitary tumor
growth hormone-producing pituitary tumor
nonfunctioning pituitary tumor
prolactin-producing pituitary tumor
recurrent pituitary tumor
TSH producing pituitary tumor
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2005-11-21
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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.

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 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

Primary outcomes:
measure: Short-term adverse effects as assessed by a questionnaire
timeFrame: at 1 week, 1 month, and 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: John Suh, MD
role: PRINCIPAL_INVESTIGATOR
References: