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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01885299
First Posted: June 24, 2013
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Advertek
VisionTree
Information provided by (Responsible Party):
The Radiosurgery Society
  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: SRS/SBRT

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Other
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 ]

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

Other Outcome Measures:
  • 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.


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: SRS/SBRT
Intervention varies by condition being treated.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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:
Tipton KN, Sullivan N, Bruening W, Inamdar R, Launders J, Uhl S, Schoelles KM. Stereotactic Body Radiation Therapy [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 May. Available from http://www.ncbi.nlm.nih.gov/books/NBK55723/
Dieterich S, Gibbs IC. The CyberKnife in clinical use: current roles, future expectations. Front Radiat Ther Oncol. 2011;43:181-94. doi: 10.1159/000322423. Epub 2011 May 20. Review.
Wowra B, Muacevic A, Tonn JC. CyberKnife radiosurgery for brain metastases. Prog Neurol Surg. 2012;25:201-9. doi: 10.1159/000331193. Epub 2012 Jan 6. Review.
Sarwate D, Sarkar S, Krimsky WS, Burgan CM, Patel K, Evans R, Harley DP. Optimization of mediastinal staging in potential candidates for stereotactic radiosurgery of the chest. J Thorac Cardiovasc Surg. 2012 Jul;144(1):81-6. doi: 10.1016/j.jtcvs.2012.03.004. Epub 2012 Apr 11.
Sohn S, Chung CK. The role of stereotactic radiosurgery in metastasis to the spine. J Korean Neurosurg Soc. 2012 Jan;51(1):1-7. doi: 10.3340/jkns.2012.51.1.1. Epub 2012 Jan 31.
Davis JN, Medbery C, Sharma S, Pablo J, Kimsey F, Perry D, Muacevic A, Mahadevan A. Stereotactic body radiotherapy for centrally located early-stage non-small cell lung cancer or lung metastases from the RSSearch(®) patient registry. Radiat Oncol. 2015 May 15;10:113. doi: 10.1186/s13014-015-0417-5.
Davis JN, Medbery C 3rd, Sharma S, Perry D, Pablo J, D'Ambrosio DJ, McKellar H, Kimsey FC, Chomiak PN, Mahadevan A. Stereotactic body radiotherapy for early-stage non-small cell lung cancer: clinical outcomes from a National Patient Registry. J Radiat Oncol. 2015;4(1):55-63. Epub 2015 Jan 31.
Davis JN, Medbery C 3rd, Sharma S, Danish A, Mahadevan A. The RSSearch™ Registry: patterns of care and outcomes research on patients treated with stereotactic radiosurgery and stereotactic body radiotherapy. Radiat Oncol. 2013 Nov 25;8:275. doi: 10.1186/1748-717X-8-275.
Ricco A, Davis J, Rate W, Yang J, Perry D, Pablo J, D'Ambrosio D, Sharma S, Sundararaman S, Kolker J, Creach KM, Lanciano R. Lung metastases treated with stereotactic body radiotherapy: the RSSearch® patient Registry's experience. Radiat Oncol. 2017 Feb 1;12(1):35. doi: 10.1186/s13014-017-0773-4.
Davis J, Sharma S, Shumway R, Perry D, Bydder S, Simpson CK, D'Ambrosio D. Stereotactic Body Radiotherapy for Clinically Localized Prostate Cancer: Toxicity and Biochemical Disease-Free Outcomes from a Multi-Institutional Patient Registry. Cureus. 2015 Dec 4;7(12):e395. doi: 10.7759/cureus.395.
Singh R, Davis J, Sharma S. Stereotactic Radiosurgery for Trigeminal Neuralgia: A Retrospective Multi-Institutional Examination of Treatment Outcomes. Cureus. 2016 Apr 3;8(4):e554. doi: 10.7759/cureus.554.

Responsible Party: The Radiosurgery Society
ClinicalTrials.gov Identifier: NCT01885299     History of Changes
Obsolete Identifiers: NCT01563549
Other Study ID Numbers: RSSearch Patient Registry
First Submitted: June 20, 2013
First Posted: June 24, 2013
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
Trigeminal Neuralgia
Trigeminal Nerve Diseases
Facial Neuralgia
Congenital Abnormalities
Arteriovenous Malformations
Hemangioma
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
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases


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