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CompletedNCT00255671Updated Jul 27, 2020

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

An observational study in Brain and Central Nervous System Tumors, Metastatic Cancer and Radiation Toxicity, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-27.

Sponsored by Case Comprehensive Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
76
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Nervous System Neoplasms

538 studies on the registry are indexed under Nervous System Neoplasms; 14 are open to participants now.

This study's enrollment of 76 is below the median of 87 across 50 observational studies indexed under Nervous System Neoplasms.

Browse Nervous System Neoplasms studies →

Lead sponsor

Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinic

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
76 participants (actual)
Biospecimen retention
None retained

Interventions

  • OtherQuestionnaire

    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.

06

What researchers measure

Primary outcomes

  1. Short-term adverse effects as assessed by a questionnaire

    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.

    Time frame: at 1 week, 1 month, and 2 months

07

Study locations

1 site
  • Cleveland Clinic Taussig Cancer Center
    Cleveland, Ohio 44195, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00255671
Lead sponsor
Case Comprehensive Cancer Center
Responsible party
Sponsor
First posted
Nov 21, 2005
Start date
May 2005
Primary completion
Apr 2008
Completion
May 2012
Last update
Jul 27, 2020

Study contacts

John Suh, MD
principal investigator · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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