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

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
Target Follow-Up Duration:	20 Years
Official Title:	Multi-Institution Registry of SRS/SBRT Procedures

Resource links provided by NLM:

Genetics Home Reference related topics: Parkes Weber syndrome capillary malformation-arteriovenous malformation syndrome

MedlinePlus related topics: Trigeminal Neuralgia

Genetic and Rare Diseases Information Center resources: Trigeminal Neuralgia

U.S. FDA Resources

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: 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


Ages Eligible for Study:	Child, Adult, Senior
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 25 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.


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:	June 1, 2016
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 Vascular Malformations Cardiovascular Abnormalities Neuralgia Hemangioma Trigeminal Neuralgia Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases	Signs and Symptoms 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

ClinicalTrials.gov processed this record on September 23, 2016