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

NCT00255671 | Completed DMC

• 1 other identifier: CASE4Z05
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

  at 1 week, 1 month, and 2 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: NONE RETAINED

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

MeSH Terms

Conditions

Central Nervous System Neoplasms; Neoplasm Metastasis; Radiation Injuries; Brain Neoplasms; Astrocytoma; Ependymoma; Meningioma; Oligodendroglioma; Choroid Plexus Neoplasms; Craniopharyngioma; Neuroectodermal Tumors, Primitive; Glioblastoma; Gliosarcoma; Medulloblastoma; Pinealoma; Glioma, Subependymal; Glioma; Growth Hormone-Secreting Pituitary Adenoma; Pituitary Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Cerebral Ventricle Neoplasms; Adenoma; Endocrine Gland Neoplasms; Pituitary Diseases; Hypothalamic Diseases; Endocrine System Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• John Suh, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2005
• First Posted: November 21, 2005
• Study Start: May 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2012
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

US (1)