RSSearch Patient Registry-Long Term Study of Use of SRS/SBRT

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Advertek
Information provided by (Responsible Party):
The Radiosurgery Society
ClinicalTrials.gov Identifier:
NCT01885299
First received: June 20, 2013
Last updated: September 4, 2014
Last verified: September 2014

June 20, 2013
September 4, 2014
March 2012
December 2020   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01885299 on ClinicalTrials.gov Archive Site
Local recurrence [ Time Frame: One to Five years ] [ Designated as safety issue: No ]
Same as current
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.
Treatment toxicity [ Time Frame: Immediate -5 years ] [ Designated as safety issue: Yes ]
 
RSSearch Patient Registry-Long Term Study of Use of SRS/SBRT
Multi-Institution Registry of SRS/SBRT Procedures

The RSSearch® Registry is an international multi-year database designed to track SRS/SBRT (Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy) 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.)

The Registry is designed to help SRS/SBRT (Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy) 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.

Observational [Patient Registry]
Observational Model: Cohort
20 Years
Not Provided
Non-Probability Sample

Any patients who have a SRS/SBRT procedure

  • Neoplasms
  • Arteriovenous Malformation of Central Nervous System
  • Trigeminal Neuralgia
Radiation: Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy
Intervention varies by condition being treated.
Other Name: SRS, SBRT
Patients being treated by SRS/SBRT
Patients with a condition being considered for treatment by SRS/SBRT
Intervention: Radiation: Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
25000
December 2025
December 2020   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Australia
 
NCT01885299
RSSearch Patient Registry
No
The Radiosurgery Society
The Radiosurgery Society
Advertek
Study Director: Clinton Medbery, MD The Radiosurgery Society
The Radiosurgery Society
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP