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

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ClinicalTrials.gov Identifier: NCT01885299
Recruitment Status : Enrolling by invitation
First Posted : June 24, 2013
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Neoplasms Arteriovenous Malformation of Central Nervous System Trigeminal Neuralgia Radiation: 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.


Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 25000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 20 Years
Official Title: Multi-Institution Registry of SRS/SBRT Procedures
Study Start Date : March 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Patients being treated by SRS/SBRT
Patients with a condition being considered for treatment by SRS/SBRT
Radiation: SRS/SBRT
Intervention varies by condition being treated.


Outcome Measures

Primary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Local recurrence [ Time Frame: One to Five years ]

Other Outcome Measures:
  1. Treatment toxicity [ Time Frame: Immediate -5 years ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885299


  Show 28 Study Locations
Sponsors and Collaborators
The Radiosurgery Society
Advertek
VisionTree
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
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

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:
Neuralgia
Congenital Abnormalities
Arteriovenous Malformations
Hemangioma
Trigeminal Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases