Clinical trial NCT01885299: RSSearch Patient Registry-Long Term Study of Use of SRS/SBRT
Official title: Multi-Institution Registry of SRS/SBRT Procedures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasms
Arteriovenous Malformation of Central Nervous System
Trigeminal Neuralgia
Keywords: Radiosurgery
CyberKnife
Benign tumors
Malignant tumors
Cranial tumors
Extracranial tumors
Lung
Liver
Pancreas
Prostate
Stereotactic radiosurgery
Stereotactic body radiotherapy
Lead sponsor: The Radiosurgery Society
Sponsor class: OTHER
Collaborators: name: VisionTree
First posted: 2013-06-24
Enrollment: 50000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients who have a SRS/SBRT procedure

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.)

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 Vision Tree, 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 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 or verbally agree to participation

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

Primary outcomes:
measure: Overall survival
timeFrame: Up to 5 years
Secondary outcomes:
measure: Local and distant recurrence
timeFrame: One to Five years
Other outcomes:
measure: Treatment toxicity
timeFrame: Immediate -5 years
Locations:
city: Colorado Springs
country: United States
facility: Penrose Cancer Center
state: Colorado
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center, University of Miami
state: Florida
city: Brunswick
country: United States
facility: Southeast Georgia Health System
state: Georgia
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Egg Harbor Township
country: United States
facility: AtlantiCare Regional Medical Center and AtlantiCare Cancer Care Institute
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center
state: New Jersey
city: Toms River
country: United States
facility: NJ Cyberknife at Community Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia CyberKnife
state: Pennsylvania
city: Pottstown
country: United States
facility: Pottstown Memorial Medical Center
state: Pennsylvania
city: Chattanooga
country: United States
facility: Cyberknife at Erlanger
state: Tennessee
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
Study officials:
affiliation: The Radiosurgery Society
name: Anand Mahadevan, MD
role: STUDY_DIRECTOR
References:
citation: 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/
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.