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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01885299
Registration number
NCT01885299
Ethics application status
Date submitted
20/06/2013
Date registered
24/06/2013
Date last updated
3/05/2024
Titles & IDs
Public title
RSSearch Patient Registry-Long Term Study of Use of SRS/SBRT
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Scientific title
Multi-Institution Registry of SRS/SBRT Procedures
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Secondary ID [1]
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RSSearch Patient Registry
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasms
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Arteriovenous Malformation of Central Nervous System
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Trigeminal Neuralgia
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Condition category
Condition code
Neurological
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Other neurological disorders
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Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Other - SRS/SBRT
Patients being treated by SRS/SBRT - Patients with a condition being considered for treatment by SRS/SBRT
Treatment: Other: SRS/SBRT
Intervention varies by condition being treated.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall survival
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Assessment method [1]
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Survival from time of treatment to death
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Timepoint [1]
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Up to 5 years
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Secondary outcome [1]
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Local and distant recurrence
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Assessment method [1]
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Calculated from time of treatment to recurrence
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Timepoint [1]
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One to Five years
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Eligibility
Key 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 or verbally agree to participation
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* There are no specific exclusion criteria, but patients who are unwilling to sign the ICD or who decline participation will not be included
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2030
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Actual
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Sample size
Target
50000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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- Nedlands
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Recruitment outside Australia
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United States of America
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State/province [1]
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Michigan
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Pennsylvania
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Country [8]
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United States of America
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State/province [8]
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Tennessee
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Country [9]
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United States of America
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State/province [9]
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West Virginia
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Radiosurgery Society
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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VisionTree
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Address [1]
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Ethics approval
Ethics application status
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Summary
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.)
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Trial website
https://clinicaltrials.gov/study/NCT01885299
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Trial related presentations / 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. Report No.: 10(11)-EHC058-EF. 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;43:181-194. doi: 10.1159/000322423. Epub 2011 May 20. 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. 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((R)) 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. doi: 10.1007/s13566-014-0177-0. 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(R) 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. Mahadevan A, Blanck O, Lanciano R, Peddada A, Sundararaman S, D'Ambrosio D, Sharma S, Perry D, Kolker J, Davis J. Stereotactic Body Radiotherapy (SBRT) for liver metastasis - clinical outcomes from the international multi-institutional RSSearch(R) Patient Registry. Radiat Oncol. 2018 Feb 13;13(1):26. doi: 10.1186/s13014-018-0969-2.
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Public notes
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Contacts
Principal investigator
Name
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Anand Mahadevan, MD
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Address
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The Radiosurgery Society
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jan Jenkins, RN
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Address
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Phone
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Informed Consent Form
https://cdn.clinicaltrials.gov/large-docs/99/NCT01885299/Prot_ICF_000.pdf
Informed consent form
Study Protocol and Informed Consent Form
https://cdn.clinicaltrials.gov/large-docs/99/NCT01885299/Prot_ICF_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01885299
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