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

• Sponsor: The Radiosurgery Society (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01885299
• Collaborator: VisionTree (Other)
• Enrollment: 50,000
• Locations: 25
• Duration (Months): 165
• Patients Per Site: 2000
• Patients Per Site Per Month: 12.1

Study Details

Study Description

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.)

Condition or Disease	Intervention/Treatment	Phase
Neoplasms; Arteriovenous Malformation of Central Nervous System; Trigeminal Neuralgia	Radiation: SRS/SBRT

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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50000 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Multi-Institution Registry of SRS/SBRT Procedures
• Study Start Date: Mar 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Overall survival [Up to 5 years]

   Survival from time of treatment to death

Secondary Outcome Measures

1. Local and distant recurrence [One to Five years]

   Calculated from time of treatment to recurrence

Other Outcome Measures

1. Treatment toxicity [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penrose Cancer Center	Colorado Springs	Colorado	United States	80907
2	Memorial Regional Hospital	Hollywood	Florida	United States	33021
3	Baptist Health/Miami Cancer Institute	Miami	Florida	United States	33176
4	Doctors Hospital of Augusta	Augusta	Georgia	United States	30909
5	Southeast Georgia Health System	Brunswick	Georgia	United States	31520
6	St. Joseph's Candler	Savannah	Georgia	United States	31405
7	Franklin Square Hospital	Baltimore	Maryland	United States	21237
8	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
9	Henry Ford Health System	Detroit	Michigan	United States	48202
10	AtlantiCare Regional Medical Center and AtlantiCare Cancer Care Institute	Egg Harbor Township	New Jersey	United States	08234
11	St. Peter's University Hospital	New Brunswick	New Jersey	United States	08901
12	Riverview Medical Center	Red Bank	New Jersey	United States	07701
13	NJ Cyberknife at Community Medical Center	Toms River	New Jersey	United States	08755
14	Montefiore Medical Center	Bronx	New York	United States	10502
15	St. Anthony Hospital	Oklahoma City	Oklahoma	United States	73102
16	Geisinger Health System	Danville	Pennsylvania	United States	17822
17	Allegheny Health Network	Monroeville	Pennsylvania	United States	15146
18	Philadelphia CyberKnife	Philadelphia	Pennsylvania	United States	19083
19	Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19104
20	Pottstown Memorial Medical Center	Pottstown	Pennsylvania	United States	19464
21	Cyberknife at Erlanger	Chattanooga	Tennessee	United States	37403
22	St. Francis Hospital	Memphis	Tennessee	United States	38119
23	St. Mary's Medical Center	Huntington	West Virginia	United States	25701
24	Sir Charles Gairdner Hospital	Nedlands		Australia
25	Acibadem University	Istanbul		Turkey

Sponsors and Collaborators

• The Radiosurgery Society
• VisionTree

Investigators

• Study Director: Anand Mahadevan, MD, The Radiosurgery Society

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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, 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.
• 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. Review.
• 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.
• 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.
• 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.
• 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.
• 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/
• 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.

• Responsible Party: The Radiosurgery Society
• ClinicalTrials.gov Identifier: NCT01885299
• Other Study ID Numbers: RSSearch Patient Registry; NCT01563549
• First Posted: Jun 24, 2013
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

• 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: Trigeminal Neuralgia; Neuralgia; Arteriovenous Malformations

Study Results

No Results Posted as of Jul 21, 2021