NeoplasmsNCT01885299
RSSearch Patient Registry-Long Term Study of Use of SRS/SBRT
An observational study of Neoplasms and Arteriovenous Malformation of Central Nervous System, run by The Radiosurgery Society at 13 sites in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasms, Arteriovenous Malformation of Central Nervous System, Trigeminal Neuralgia
- What is being tested?
- SRS/SBRT
- Type of treatment
- Surgery or procedure
- How many people
- 50,000 participants
- Where
- 13 sitesUnited States
- Study dates
- Mar 2012to Dec 2030
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patients who have a SRS/SBRT procedure
Who may be able to join
- 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
Who cannot join
- There are no specific exclusion criteria, but patients who are unwilling to sign the ICD or who decline participation will not be included
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jan Jenkins, RN contact
Joanne Davis, PHD contact
13 sites in 1 country
United States13 sites, 13 recruiting
- Enrolling by invitation
Southeast Georgia Health System
Brunswick, Georgia, 31520
- Enrolling by invitation
Cyberknife at Erlanger
Chattanooga, Tennessee, 37403
- Enrolling by invitation
Penrose Cancer Center
Colorado Springs, Colorado, 80907
- Enrolling by invitation
Geisinger Health System
Danville, Pennsylvania, 17822
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Celina Kirsch, P.A., 313-640-2345, CKirsch2@hfhs.org
Parag Parikh, M.D.
- Enrolling by invitation
AtlantiCare Regional Medical Center and AtlantiCare Cancer Care Institute
Egg Harbor, New Jersey, 08234
- Enrolling by invitation
St. Mary's Medical Center
Huntington, West Virginia, 25701
- Recruiting
Sylvester Comprehensive Cancer Center, University of Miami
Miami, Florida, 33146
Gregory A Azzam, MD, gxa338@med.miami.edu
Gregory A Azzam, MD
- Enrolling by invitation
Philadelphia CyberKnife
Philadelphia, Pennsylvania, 19083
- Enrolling by invitation
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, 19464
- Enrolling by invitation
Riverview Medical Center
Red Bank, New Jersey, 07701
- Enrolling by invitation
Montefiore Medical Center
The Bronx, New York, 10502
- Enrolling by invitation
NJ Cyberknife at Community Medical Center
Toms River, New Jersey, 08755
About this study
Official title: 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.)
Read the 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.
- Being tested
- SRS/SBRT
- Keywords
- Radiosurgery, CyberKnife, Benign tumors, Malignant tumors, Cranial tumors, Extracranial tumors, Lung, Liver, Pancreas, Prostate, Stereotactic radiosurgery, Stereotactic body radiotherapy
- Medical subject headings
- Neoplasms, Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRS/SBRTRadiation
Intervention varies by condition being treated.
| Study group | Role | What they receive |
|---|---|---|
| Patients being treated by SRS/SBRT | Patients with a condition being considered for treatment by SRS/SBRT Receives: Radiation: SRS/SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Survival from time of treatment to death
Measured: Up to 5 years
Secondary outcomes (1)
Local and distant recurrence
Calculated from time of treatment to recurrence
Measured: One to Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- The Radiosurgery Society
- Sponsor type
- University, hospital or other
- Collaborators
- VisionTree
- Responsible party
- Sponsor
- Investigators
- Anand Mahadevan, MD, Study director, The Radiosurgery Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885299
- Sponsor's protocol ID
- RSSearch Patient Registry
- Status last verified
- May 2024
- First submitted
- 20 Jun 2013
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
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/
PubMed 21735562Dieterich 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.
PubMed 21625154Wowra 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.
PubMed 22236681Sarwate 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.
PubMed 22498085Sohn 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.
PubMed 22396835Davis 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.
PubMed 25975848Davis 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.
PubMed 25774243Davis 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.
PubMed 24274599Ricco 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.
PubMed 28143558Davis 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.
PubMed 26798571Singh 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.
PubMed 27182468Mahadevan 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.
PubMed 29439707
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Institution Registry of SRS/SBRT Procedures
- ClinicalTrials.gov ID
- NCT01885299
- Acronym / sponsor ID
- RSSearch Patient Registry
- Keywords
- Radiosurgery, CyberKnife, Benign tumors, Malignant tumors, Cranial tumors, Extracranial tumors, Lung, Liver
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- The Radiosurgery SocietyUniversity, hospital or other
- Collaborators
- VisionTree
- Study start
- Mar 2012
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients being treated by SRS/SBRT | – | Radiation: SRS/SBRTPatients with a condition being considered for treatment by SRS/SBRT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patients who have a SRS/SBRT procedure
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria, but patients who are unwilling to sign the ICD or who decline participation will not be included
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRS/SBRTIntervention varies by condition being treated. | Radiation | Patients being treated by SRS/SBRT |
Primary outcome
Overall survival
Time frame: Up to 5 years
Survival from time of treatment to death
1 secondary outcome
Local and distant recurrence
Time frame: One to Five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 21735562Tipton 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/
- Background: PubMed 21625154Dieterich 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.
- Background: PubMed 22236681Wowra 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.
- Background: PubMed 22498085Sarwate 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.
- Background: PubMed 22396835Sohn 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.
- Background: PubMed 25975848Davis 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.
- Background: PubMed 25774243Davis 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.
- Background: PubMed 24274599Davis 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.
- Background: PubMed 28143558Ricco 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.
- Background: PubMed 26798571Davis 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.
- Background: PubMed 27182468Singh 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.
- Derived from this study: PubMed 29439707Mahadevan 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Jenkins, RN contact
Joanne Davis, PHD contact
Anand Mahadevan, MD study director
The Radiosurgery Society
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Arteriovenous Malformation of Central Nervous System, run by The Radiosurgery Society at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Jenkins, RN (jjenkins@therss.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01885299, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.