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

Neoplasms Clinical Trial

Official title:

Multi-Institution Registry of SRS/SBRT Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01885299
• Other study ID #: RSSearch Patient Registry
• Status: Recruiting
• Start date: March 2012
• Est. completion date: December 2030

Study information

• Verified date: June 2023
• Source: The Radiosurgery Society
• Contact: Jan Jenkins, RN
• Email: jjenkins[@]therss.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.)

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.

Other known NCT identifiers

• NCT01563549

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Malformation of Central Nervous System
• Arteriovenous Malformations
• Neoplasms
• Neuralgia
• Trigeminal Neuralgia

Intervention

Radiation:
• SRS/SBRT
Intervention varies by condition being treated.

Locations

Country	Name	City	State
Australia	Sir Charles Gairdner Hospital	Nedlands
United States	Montefiore Medical Center	Bronx	New York
United States	Southeast Georgia Health System	Brunswick	Georgia
United States	Cyberknife at Erlanger	Chattanooga	Tennessee
United States	Penrose Cancer Center	Colorado Springs	Colorado
United States	Geisinger Health System	Danville	Pennsylvania
United States	Henry Ford Health System	Detroit	Michigan
United States	AtlantiCare Regional Medical Center and AtlantiCare Cancer Care Institute	Egg Harbor Township	New Jersey
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	Sylvester Comprehensive Cancer Center, University of Miami	Miami	Florida
United States	Philadelphia CyberKnife	Philadelphia	Pennsylvania
United States	Pottstown Memorial Medical Center	Pottstown	Pennsylvania
United States	Riverview Medical Center	Red Bank	New Jersey
United States	NJ Cyberknife at Community Medical Center	Toms River	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
The Radiosurgery Society	VisionTree

Countries where clinical trial is conducted

United States,  Australia, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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/ — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment toxicity	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.	Immediate -5 years
Primary	Overall survival	Survival from time of treatment to death	Up to 5 years
Secondary	Local and distant recurrence	Calculated from time of treatment to recurrence	One to Five years