Completed

NCT Number: NCT00255671

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

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.

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Key information

Conditions

Brain and Central Nervous System Tumors Adenoma Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cerebral Ventricle Neoplasms Choroid Plexus Neoplasms Craniopharyngioma Endocrine Gland Neoplasms Endocrine System Diseases Ependymoma Glioblastoma Glioma Glioma, Subependymal Gliosarcoma Growth Hormone-Secreting Pituitary Adenoma Hypothalamic Diseases Hypothalamic Neoplasms Medulloblastoma Meningeal Neoplasms Meningioma Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Oligodendroglioma Pathologic Processes Pathological Conditions, Signs and Symptoms Pinealoma Pituitary Diseases Pituitary Neoplasms Radiation Injuries Radiation Toxicity Supratentorial Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

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.

Primary outcomes

Short-term adverse effects as assessed by a questionnaire

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

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.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2012
First posted: Nov 21, 2005
Registry last updated: Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed