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

February 29, 2024 updated by: The Radiosurgery Society

Multi-Institution Registry of SRS/SBRT Procedures

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.)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Nedlands, Australia
        • Enrolling by invitation
        • Sir Charles Gairdner Hospital
  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Acibadem University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Enis Ozyar, M.D.
        • Sub-Investigator:
          • Gamze Ugurluer, M.D.
        • Sub-Investigator:
          • Gokhan Aydin, M.D.
  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Enrolling by invitation
        • Penrose Cancer Center
    • Florida
      • Miami, Florida, United States, 33146
        • Not yet recruiting
        • Sylvester Comprehensive Cancer Center, University of Miami
        • Contact:
        • Principal Investigator:
          • Gregory A Azzam, MD
      • Miami, Florida, United States, 33176
        • Recruiting
        • Baptist Health/Miami Cancer Institute
        • Contact:
        • Principal Investigator:
          • Michael Chuong, M.D., FACRO
      • Miami, Florida, United States
        • Recruiting
        • Sylvester Comprehensive Cancer Center at University of Miami
        • Contact:
        • Principal Investigator:
          • Lorraine Portelance, M.D.
        • Sub-Investigator:
          • Gregory A Azzam, M.D.
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Enrolling by invitation
        • Doctors Hospital of Augusta
      • Brunswick, Georgia, United States, 31520
        • Enrolling by invitation
        • Southeast Georgia Health System
      • Savannah, Georgia, United States, 31405
        • Enrolling by invitation
        • St. Joseph's Candler
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Contact:
        • Principal Investigator:
          • Parag Parikh, M.D.
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Enrolling by invitation
        • AtlantiCare Regional Medical Center and AtlantiCare Cancer Care Institute
      • Red Bank, New Jersey, United States, 07701
        • Enrolling by invitation
        • Riverview Medical Center
      • Toms River, New Jersey, United States, 08755
        • Enrolling by invitation
        • NJ Cyberknife at Community Medical Center
    • New York
      • Bronx, New York, United States, 10502
        • Enrolling by invitation
        • Montefiore Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Enrolling by invitation
        • St. Anthony Hospital
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Enrolling by invitation
        • Geisinger Health System
      • Philadelphia, Pennsylvania, United States, 19083
        • Enrolling by invitation
        • Philadelphia CyberKnife
      • Pottstown, Pennsylvania, United States, 19464
        • Enrolling by invitation
        • Pottstown Memorial Medical Center
      • West Reading, Pennsylvania, United States, 19611
        • Enrolling by invitation
        • McGlinn Cancer Institute, Reading Hospital
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Enrolling by invitation
        • Cyberknife at Erlanger
      • Memphis, Tennessee, United States, 38119
        • Enrolling by invitation
        • St. Francis Hospital
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Enrolling by invitation
        • St. Mary's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any patients who have a SRS/SBRT procedure

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to 5 years
Survival from time of treatment to death
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local and distant recurrence
Time Frame: One to Five years
Calculated from time of treatment to recurrence
One to Five years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment toxicity
Time Frame: 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.
Immediate -5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Radiosurgery Society

Collaborators

VisionTree

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimated)

June 24, 2013

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSSearch Patient Registry

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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