Prospective Study on the Short-Term Adverse Effects From Gamma Knife Radiosurgery
18 Years
N/A
Both
Brain and Central Nervous System Tumors, Metastatic Cancer, Radiation Toxicity
Trial Information
Prospective Study on the Short-Term Adverse Effects From Gamma Knife Radiosurgery
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.
Inclusion 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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Short-term adverse effects as assessed by a questionnaire
Outcome Description:
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.
Outcome Time Frame:
at 1 week, 1 month, and 2 months
Safety Issue:
No
Principal Investigator
John Suh, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CASE4Z05
NCT ID:
NCT00255671
Start Date:
May 2005
Completion Date:
May 2012
Related Keywords:
- Brain and Central Nervous System Tumors
- Metastatic Cancer
- Radiation Toxicity
- 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
- Brain Neoplasms
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Radiation Injuries
Name | Location |
|---|---|
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
