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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
  Purpose

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.)


Condition Intervention
Neoplasms
Arteriovenous Malformation of Central Nervous System
Trigeminal Neuralgia
Radiation: Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Target Follow-Up Duration: 20 Years
Official Title: Multi-Institution Registry of SRS/SBRT Procedures

Resource links provided by NLM:


Further study details as provided by The Radiosurgery Society:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local recurrence [ Time Frame: One to Five years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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: 25000
Study Start Date: March 2012
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2020 (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/Stereotactic Body Radiation Therapy
Intervention varies by condition being treated.
Other Name: SRS, SBRT

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any patients who have a SRS/SBRT procedure

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885299

  Show 21 Study Locations
Sponsors and Collaborators
The Radiosurgery Society
Advertek
Investigators
Study Director: Clinton Medbery, MD The Radiosurgery Society
  More Information

Publications:
Responsible Party: The Radiosurgery Society
ClinicalTrials.gov Identifier: NCT01885299     History of Changes
Obsolete Identifiers: NCT01563549
Other Study ID Numbers: RSSearch Patient Registry
Study First Received: June 20, 2013
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board (USA)

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:
Trigeminal Neuralgia
Trigeminal Nerve Diseases
Arteriovenous Malformations
Congenital Abnormalities
Hemangioma
Cardiovascular Abnormalities
Cardiovascular Diseases
Cranial Nerve Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Nervous System Diseases
Vascular Diseases
Vascular Malformations

ClinicalTrials.gov processed this record on November 25, 2014