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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00255671
First received: November 18, 2005
Last updated: June 14, 2012
Last verified: June 2012
  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
Metastatic Cancer
Radiation Toxicity
Other: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Study on the Short-Term Adverse Effects From Gamma Knife Radiosurgery

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Short-term adverse effects as assessed by a questionnaire [ Time Frame: at 1 week, 1 month, and 2 months ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   None Retained

Determine the incidence and types of acute complications in patients undergoing stereotactic radiosurgery for brain tumors or other brain disorders.


Enrollment: 76
Study Start Date: May 2005
Study Completion Date: May 2012
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: John Suh, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00255671     History of Changes
Other Study ID Numbers: CASE4Z05, P30CA043703, CASE4Z05, CCF-8078
Study First Received: November 18, 2005
Last Updated: June 14, 2012
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Neoplasm Metastasis
Nervous System Neoplasms
Radiation Injuries
Neoplasms
Neoplasms by Site
Neoplastic Processes
Nervous System Diseases
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014