Brain and Central Nervous System TumorsNCT00255671
Acute Side Effects in Patients Who Are Undergoing Stereotactic Radiosurgery for Brain Tumors or Other Brain Disorders
An observational study of Brain and Central Nervous System Tumors and Metastatic Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Metastatic Cancer, Radiation Toxicity
- What is being tested?
- Questionnaire
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Prospective Study on the Short-Term Adverse Effects From Gamma Knife Radiosurgery
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.
- Being tested
- Questionnaire
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Neoplasm Metastasis, Radiation Injuries, Brain Neoplasms, Astrocytoma, Ependymoma, Meningioma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 1 week, 1 month, and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startMay 2005
- Primary completionApr 2008
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Suh, MD, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255671
- Sponsor's protocol ID
- CASE4Z05
- Status last verified
- Jul 2020
- First submitted
- 18 Nov 2005
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Short-Term Adverse Effects From Gamma Knife Radiosurgery
- ClinicalTrials.gov ID
- NCT00255671
- Acronym / sponsor ID
- CASE4Z05
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePatients 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. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Suh, MD principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Central Nervous System Tumors and Metastatic Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term adverse effects as assessed by a questionnaire (time frame: at 1 week, 1 month, and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.