RSSearch Registry-Long Term Study of Use of SRS/SBRT to Treat Tumors and Other Functional Diseases
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Purpose
The RSSearch® Registry is an international multi-year database designed to track SRS/SBRT (stereotactic radiosurgery/stereotactic body radiotherapy) utilization, treatment practices and outcomes to help determine, over time, the most effective use of these systems in management of patients with life threatening tumors and other diseases. (This study was formally called ReCKord and included the Cyberknife only; The ReCKord study continues as a CyberKnife subset of RSSearch.)
| Condition | Intervention |
|---|---|
|
Neoplasms Arteriovenous Malformations Trigeminal Neuralgia |
Radiation: Stereotactic Radiosurgery/Stereotactice body radiotherapy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Multi-Institution Registry of SRS/SBRT Procedures |
- Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Local recurrence [ Time Frame: One to Five years ] [ Designated as safety issue: No ]
- Treatment toxicity [ Time Frame: Immediate -5 years ] [ Designated as safety issue: Yes ]Complications of treatment. These complications are organ specific depending on which organ is being treated. For example, if the prostate is being treated,there may be rectal and urinary complications. If the brain is being treated, there may be headaches or nausea. The Radiation Therapy Oncology Group (RTOG) scale used for defining and measuring complications of radiotherapy is incorporated into the Registry database.
| Estimated Enrollment: | 12000 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patients being treated by SRS/SBRT
Patients with a condition being considered for treatment by SRS/SBRT
|
Radiation: Stereotactic Radiosurgery/Stereotactice body radiotherapy
Intervention varies by condition being treated.
Other Names:
|
Detailed Description:
The Registry is designed to help SRS/SBRT users to understand utilization of and key treatment outcomes for these treatment approaches. Some of the objectives include:
- Allow participants to record information about usage of SRS/SBRT in everyday practice, including patient characteristics and disease information, treatment plans and outcomes
- Provide participants with ready access to data for publication of their own experience and as a tool for establishing collaborations with other participating sites
- Facilitate quality improvement efforts for individual treatment providers
- Understand the effectiveness of different treatment plans for different types of lesions, diseases and treatments
The Registry tracks select outcomes for each condition treated by SRS/SBRT (for example, PSA for prostate cancer); the Registry also provides individual participants the ability to add additional outcomes for each and any condition of specific interest to their institutions.
The Registry is hosted by Advertek, Inc who is an independent vendor of electronic registries; they are responsible for HIPAA compliance, including all security mechanisms.
Patients will be enrolled prospectively. Some retrospective patient data is likely to be included in order to capture both short and longer term outcomes data.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Any patients who have a SRS/SBRT procedure
Inclusion Criteria:
- Diagnosis of benign or malignant tumors or other conditions deemed treatable by stereotactic radiosurgery or stereotactic body radiotherapy
- Willingness to sign an Informed Consent Document
Exclusion Criteria:
- There are no specific exclusion criteria, but patients who are unwilling to sign the ICD will not be included
Contacts and Locations
Show 23 Study Locations| Study Director: | Clinton A Medbery, MD | Radiosurgery Society |
More Information
Publications:
| Responsible Party: | The Radiosurgery Society |
| ClinicalTrials.gov Identifier: | NCT01563549 History of Changes |
| Other Study ID Numbers: | RSS 2012 |
| Study First Received: | March 23, 2012 |
| Last Updated: | August 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Radiosurgery Society:
|
Radiosurgery CyberKnife Benign tumors Malignant tumors Cranial tumors Extracranial tumors |
Lung Liver Pancreas Prostate Stereotactic radiosurgery Stereotactic body radiotherapy |
Additional relevant MeSH terms:
|
Congenital Abnormalities Arteriovenous Malformations Aneurysm Hemangioma Neoplasms Neuralgia Trigeminal Neuralgia Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Vascular Diseases |
Neoplasms, Vascular Tissue Neoplasms by Histologic Type Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Trigeminal Nerve Diseases Cranial Nerve Diseases |
ClinicalTrials.gov processed this record on May 19, 2013