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


N/A
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Metastatic Cancer, Radiation Toxicity

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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 CenterCleveland, Ohio  44195