Metastatic Malignant Neoplasm to the Adult BrainPhase 3TRICKNCT01353573
Robotic Compared to Fixed Gantry Radiosurgery for Brain Metastases
A Phase 3 study testing Fixed Gantry Radiosurgery and Robotic Radiosurgery in people with Metastatic Malignant Neoplasm to the Adult Brain, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Radiosurgery is precisely delivered high dose radiation. It can be performed using multiple cobalt sources, a modified traditional gantry-based linear accelerator or a robotic linear accelerator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm to the Adult Brain
- What is being tested?
- Fixed Gantry Radiosurgery and Robotic Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Jul 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1-3 brain metastases from a confirmed primary extra-cranial site
Who cannot join
- Any brain metastasis >3cm in maximal diameter
- Easter Cooperative Oncology Group (ECOG) performance status >2
- Prior surgical resection or radiosurgery of a brain metastasis
- Lesion causing significant mass effect (>1cm midline shift)
- Lesion located <5mm from optic chiasm or within the brainstem
- Requires more than one fraction of radiosurgery
- Primary disease histology unknown, lymphoma or germ cell tumor
Trial locations and contacts
1 site in 1 country.
Canada1 site
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Jeffrey N Greenspoon, MD FRCPC, (905) 387-9495 ext. 64706, jeffrey.greenspoon@jcc.hhsc.ca
Jeffrey N Greenspoon, MD FRCPC
About this study
Official title: A Randomized Trial of Robotic Compared to Fixed Gantry Radiosurgery for Brain Metastases
Radiosurgery is precisely delivered high dose radiation. It can be performed using multiple cobalt sources, a modified traditional gantry-based linear accelerator or a robotic linear accelerator. The treatment of brain metastases represents the most common indication for radiosurgery while new indications for this technology are continually being discovered. With the increasing importance of radiosurgery and the resource implications for radiotherapy programs the investigators have proposed the first direct technological comparison of robotic to linear accelerator radiosurgery for brain metastases.
Read the detailed description
Radiosurgery can be performed using multiple Co-60 sources, a modified traditional gantry-based linear accelerator, or a robotic linear accelerator. Each technique has its own advantages and disadvantages. Co-60 radiosurgery has very precise target localization by using a rigid immobilization device. The requirement for rigid immobilization limits its treatments to the head and neck. Robotic radiosurgery permits precise radiation to be delivered without the requirement for rigid immobilization. Robotic radiosurgery uses real-time imagining, allowing it to track the cancer or internal structures as they move during treatment. Another advantage is that it can deliver many small beams of radiation (as many as 200) in a limited time period and can treat lesions anywhere in the body. A traditional gantry-based linear accelerator normally requires some form of immobilization and requires more time for multiple isocentre set up but can provide both radiosurgery and conventional treatments.
Brain metastases occur in up to 50% of patients with cancer. It has been reported up to 65% of patients with brain metastases will present with one to three lesions. This represents 18,000 patients in Ontario each year who would be eligible for radiosurgery as part of their management. Randomized trials have demonstrated improved palliation and overall survival when radiosurgery is added to conventional whole brain radiation therapy (WBRT). As a result the treatment of brain metastases currently represents the largest resource use for radiosurgery. During the commissioning and initial use of the first robotic radiosurgery device in Ontario (CyberKnife) the investigators became aware of its potential advantages for the treatment of brain metastases. Treatment planning time and on treatment time with robotic radiosurgery appeared to be better than with a traditional linear accelerator and patients appeared to be more comfortable with the minimal/ non-invasive immobilization required. Surprisingly, there were very little direct comparisons of robotic radiosurgery with other techniques in the literature and only one prospective randomized trial comparing two different approaches to delivering Co-60 radiosurgery was identified. Given the increasing importance of radiosurgery and the resource implications for radiation treatment programs in Ontario, this study is proposed to conduct a direct comparison of robotic to traditional linear accelerator radiosurgery for brain metastases. The primary outcome will be treatment planning and delivery time and an important secondary outcome is patient comfort. Treatment planning time will include immobilization preparation, CT simulation, image fusion, radiation planning and treatment plan quality assurance. Treatment delivery time will include patient set up, target localization and treatment delivery. The Juravinski Cancer Centre (JCC) and McMaster University are uniquely posed to perform this comparison with access to both robotic and linear accelerator radiosurgery techniques as well as research methodology expertise in clinical trials technology assessment, and health services research.
- Being tested
- Fixed Gantry Radiosurgery, Robotic Radiosurgery
- Keywords
- Brain Neoplasms, Neoplasm Metastasis, Neoplasms
- Medical subject headings
- Brain Neoplasms, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed Gantry RadiosurgeryRadiation
Also called Linear Accelerator Radiosurgery
Single fraction radiosurgery will be prescribed using a fixed gantry radiosurgery delivery system
Robotic RadiosurgeryRadiation
Also called CyberKnife Radiosurgery
Single fraction radiosurgery will be prescribed using a robotic radiosurgery system
| Study group | Role | What they receive |
|---|---|---|
| Fixed Gantry Radiosurgery | Active comparator | Single fraction radiosurgery will be prescribed using a Fixed Gantry Linear Accelerator Receives: Radiation: Fixed Gantry Radiosurgery |
| Robotic Radiosurgery | Experimental | Single fraction radiosurgery will be prescribed using a robotic linear accelerator Receives: Radiation: Robotic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiosurgery planning and delivery time
Radiosurgery Planning Time: 1) Immobilization Device Fitting 2) CT Simulation and Data Aquisition 3) Treatment Planning 4) Quality Assurance
Treatment Delivery Time: 1) Patient Setup 2) Target Localization 3) Plan Delivery
Measured: 14 days
Secondary outcomes (6)
Local Control
Local Control will be assesed using contrast enhanced MRI at 3,6 and 12 months after radiosurgery
Measured: One Year
Scattered Radiation Dose
Thermo-luminescent dosimeters will be placed on the patient during treatment delivery to measure scatter radiation dose
Measured: 14 Days
Quality of Life
EQ-5D testing will be done prior to radiosurgery and at 4 weeks and at 3,6 and 12 months after radiosurgery
Measured: One Year
Dosimetry
Once the plan is approved all dosimetric measures will be recorded.
Measured: 7 Days
Acute Toxicity
NCI Common Terminology Criteria for Adverse Events Version 4 will be used to assess acute toxicity up to and including the 3 month post radiosurgery visit
Measured: 3 months
Late Toxicity
NCI Common Terminology Criteria for Adverse Events version 4 will be used to assess late toxicity from the 3 month visit to the 12 month visit.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Metastatic Malignant Neoplasm to the Adult BrainStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Clinical Oncology Group (OCOG), Juravinski Cancer Centre Foundation
- Investigators
- Timothy Whelan, MD FRCPC, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353573
- Sponsor's protocol ID
- JNG-001
- Acronym
- TRICK
- Status last verified
- May 2011
- First submitted
- 10 May 2011
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Boudreau R, Clark M, Nkansah E. TomoTherapy, GammaKnife and CyberKnife Therapies for Patients with Tumours of the Lung, Central Nervous System, or Intra-abdomen: A Systematic Review of Clinical Effectiveness and Cost Effectiveness. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2009.
Gaspar LE, Mehta MP, Patchell RA, Burri SH, Robinson PD, Morris RE, Ammirati M, Andrews DW, Asher AL, Cobbs CS, Kondziolka D, Linskey ME, Loeffler JS, McDermott M, Mikkelsen T, Olson JJ, Paleologos NA, Ryken TC, Kalkanis SN. The role of whole brain radiation therapy in the management of newly diagnosed brain metastases: a systematic review and evidence-based clinical practice guideline. J Neurooncol. 2010 Jan;96(1):17-32. doi: 10.1007/s11060-009-0060-9. Epub 2009 Dec 4.
PubMed 19960231Regis J, Tamura M, Guillot C, Yomo S, Muraciolle X, Nagaje M, Arka Y, Porcheron D. Radiosurgery with the world's first fully robotized Leksell Gamma Knife PerfeXion in clinical use: a 200-patient prospective, randomized, controlled comparison with the Gamma Knife 4C. Neurosurgery. 2009 Feb;64(2):346-55; discussion 355-6. doi: 10.1227/01.NEU.0000337578.00814.75.
PubMed 19190462Wowra B, Muacevic A, Tonn JC. Quality of radiosurgery for single brain metastases with respect to treatment technology: a matched-pair analysis. J Neurooncol. 2009 Aug;94(1):69-77. doi: 10.1007/s11060-009-9802-y. Epub 2009 Feb 1.
PubMed 19184641Blonigen BJ, Steinmetz RD, Levin L, Lamba MA, Warnick RE, Breneman JC. Irradiated volume as a predictor of brain radionecrosis after linear accelerator stereotactic radiosurgery. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):996-1001. doi: 10.1016/j.ijrobp.2009.06.006. Epub 2009 Sep 23.
PubMed 19783374Gwak HS, Yoo HJ, Youn SM, Lee DH, Kim MS, Rhee CH. Radiosurgery for recurrent brain metastases after whole-brain radiotherapy : factors affecting radiation-induced neurological dysfunction. J Korean Neurosurg Soc. 2009 May;45(5):275-83. doi: 10.3340/jkns.2009.45.5.275. Epub 2009 May 31.
PubMed 19516944Chang EL, Hassenbusch SJ 3rd, Shiu AS, Lang FF, Allen PK, Sawaya R, Maor MH. The role of tumor size in the radiosurgical management of patients with ambiguous brain metastases. Neurosurgery. 2003 Aug;53(2):272-80; discussion 280-1. doi: 10.1227/01.neu.0000073546.61154.9a.
PubMed 12925241
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Robotic Compared to Fixed Gantry Radiosurgery for Brain Metastases
- ClinicalTrials.gov ID
- NCT01353573
- Acronym / sponsor ID
- TRICK / JNG-001
- Keywords
- Brain Neoplasms, Neoplasm Metastasis, Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Ontario Clinical Oncology Group (OCOG), Juravinski Cancer Centre Foundation
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 13 May 2011 (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.
Radiosurgery is precisely delivered high dose radiation. It can be performed using multiple cobalt sources, a modified traditional gantry-based linear accelerator or a robotic linear accelerator. The treatment of brain metastases represents the most common indication for radiosurgery while new indications for this technology are continually being discovered. With the increasing importance of radiosurgery and the resource implications for radiotherapy programs the investigators have proposed the first direct technological comparison of robotic to linear accelerator radiosurgery for brain metastases.
Detailed description
Radiosurgery can be performed using multiple Co-60 sources, a modified traditional gantry-based linear accelerator, or a robotic linear accelerator. Each technique has its own advantages and disadvantages. Co-60 radiosurgery has very precise target localization by using a rigid immobilization device. The requirement for rigid immobilization limits its treatments to the head and neck. Robotic radiosurgery permits precise radiation to be delivered without the requirement for rigid immobilization. Robotic radiosurgery uses real-time imagining, allowing it to track the cancer or internal structures as they move during treatment. Another advantage is that it can deliver many small beams of radiation (as many as 200) in a limited time period and can treat lesions anywhere in the body. A traditional gantry-based linear accelerator normally requires some form of immobilization and requires more time for multiple isocentre set up but can provide both radiosurgery and conventional treatments.
Brain metastases occur in up to 50% of patients with cancer. It has been reported up to 65% of patients with brain metastases will present with one to three lesions. This represents 18,000 patients in Ontario each year who would be eligible for radiosurgery as part of their management. Randomized trials have demonstrated improved palliation and overall survival when radiosurgery is added to conventional whole brain radiation therapy (WBRT). As a result the treatment of brain metastases currently represents the largest resource use for radiosurgery. During the commissioning and initial use of the first robotic radiosurgery device in Ontario (CyberKnife) the investigators became aware of its potential advantages for the treatment of brain metastases. Treatment planning time and on treatment time with robotic radiosurgery appeared to be better than with a traditional linear accelerator and patients appeared to be more comfortable with the minimal/ non-invasive immobilization required. Surprisingly, there were very little direct comparisons of robotic radiosurgery with other techniques in the literature and only one prospective randomized trial comparing two different approaches to delivering Co-60 radiosurgery was identified. Given the increasing importance of radiosurgery and the resource implications for radiation treatment programs in Ontario, this study is proposed to conduct a direct comparison of robotic to traditional linear accelerator radiosurgery for brain metastases. The primary outcome will be treatment planning and delivery time and an important secondary outcome is patient comfort. Treatment planning time will include immobilization preparation, CT simulation, image fusion, radiation planning and treatment plan quality assurance. Treatment delivery time will include patient set up, target localization and treatment delivery. The Juravinski Cancer Centre (JCC) and McMaster University are uniquely posed to perform this comparison with access to both robotic and linear accelerator radiosurgery techniques as well as research methodology expertise in clinical trials technology assessment, and health services research.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed Gantry Radiosurgery | Active comparator | Radiation: Fixed Gantry RadiosurgerySingle fraction radiosurgery will be prescribed using a Fixed Gantry Linear Accelerator |
| Robotic Radiosurgery | Experimental | Radiation: Robotic RadiosurgerySingle fraction radiosurgery will be prescribed using a robotic linear accelerator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1-3 brain metastases from a confirmed primary extra-cranial site
Key exclusion criteria (7 listed)
- Any brain metastasis >3cm in maximal diameter
- Easter Cooperative Oncology Group (ECOG) performance status >2
- Prior surgical resection or radiosurgery of a brain metastasis
- Lesion causing significant mass effect (>1cm midline shift)
- Lesion located <5mm from optic chiasm or within the brainstem
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 |
|---|---|---|
| Fixed Gantry RadiosurgeryAlso: Linear Accelerator RadiosurgerySingle fraction radiosurgery will be prescribed using a fixed gantry radiosurgery delivery system | Radiation | Fixed Gantry Radiosurgery |
| Robotic RadiosurgeryAlso: CyberKnife RadiosurgerySingle fraction radiosurgery will be prescribed using a robotic radiosurgery system | Radiation | Robotic Radiosurgery |
Primary outcome
Radiosurgery planning and delivery time
Time frame: 14 days
Radiosurgery Planning Time: 1) Immobilization Device Fitting 2) CT Simulation and Data Aquisition 3) Treatment Planning 4) Quality Assurance Treatment Delivery Time: 1) Patient Setup 2) Target Localization 3) Plan Delivery
6 secondary outcomes
Local Control
Time frame: One Year
Scattered Radiation Dose
Time frame: 14 Days
Quality of Life
Time frame: One Year
Dosimetry
Time frame: 7 Days
Acute Toxicity
Time frame: 3 months
Late Toxicity
Time frame: One Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2011.
- BackgroundBoudreau R, Clark M, Nkansah E. TomoTherapy, GammaKnife and CyberKnife Therapies for Patients with Tumours of the Lung, Central Nervous System, or Intra-abdomen: A Systematic Review of Clinical Effectiveness and Cost Effectiveness. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2009.
- Background: PubMed 19960231Gaspar LE, Mehta MP, Patchell RA, Burri SH, Robinson PD, Morris RE, Ammirati M, Andrews DW, Asher AL, Cobbs CS, Kondziolka D, Linskey ME, Loeffler JS, McDermott M, Mikkelsen T, Olson JJ, Paleologos NA, Ryken TC, Kalkanis SN. The role of whole brain radiation therapy in the management of newly diagnosed brain metastases: a systematic review and evidence-based clinical practice guideline. J Neurooncol. 2010 Jan;96(1):17-32. doi: 10.1007/s11060-009-0060-9. Epub 2009 Dec 4.
- Results publication: PubMed 19190462Regis J, Tamura M, Guillot C, Yomo S, Muraciolle X, Nagaje M, Arka Y, Porcheron D. Radiosurgery with the world's first fully robotized Leksell Gamma Knife PerfeXion in clinical use: a 200-patient prospective, randomized, controlled comparison with the Gamma Knife 4C. Neurosurgery. 2009 Feb;64(2):346-55; discussion 355-6. doi: 10.1227/01.NEU.0000337578.00814.75.
- Results publication: PubMed 19184641Wowra B, Muacevic A, Tonn JC. Quality of radiosurgery for single brain metastases with respect to treatment technology: a matched-pair analysis. J Neurooncol. 2009 Aug;94(1):69-77. doi: 10.1007/s11060-009-9802-y. Epub 2009 Feb 1.
- Results publication: PubMed 19783374Blonigen BJ, Steinmetz RD, Levin L, Lamba MA, Warnick RE, Breneman JC. Irradiated volume as a predictor of brain radionecrosis after linear accelerator stereotactic radiosurgery. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):996-1001. doi: 10.1016/j.ijrobp.2009.06.006. Epub 2009 Sep 23.
- Results publication: PubMed 19516944Gwak HS, Yoo HJ, Youn SM, Lee DH, Kim MS, Rhee CH. Radiosurgery for recurrent brain metastases after whole-brain radiotherapy : factors affecting radiation-induced neurological dysfunction. J Korean Neurosurg Soc. 2009 May;45(5):275-83. doi: 10.3340/jkns.2009.45.5.275. Epub 2009 May 31.
- Results publication: PubMed 12925241Chang EL, Hassenbusch SJ 3rd, Shiu AS, Lang FF, Allen PK, Sawaya R, Maor MH. The role of tumor size in the radiosurgical management of patients with ambiguous brain metastases. Neurosurgery. 2003 Aug;53(2):272-80; discussion 280-1. doi: 10.1227/01.neu.0000073546.61154.9a.
- Robotic Radiosurgery SystemLink provided by the sponsor.
- Fixed Gantry Radiosurgery SystemLink provided by the sponsor.
Related trials for Metastatic Malignant Neoplasm to the Adult Brain
RecruitingPhase 1
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
ER+, HER 2- Breast Cancer, Non-small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain
Lung Cancer, Lung Cancer Metastatic
Active, not recruitingPhase 1
Brain Tumor-Specific Immune Cells (IL13Ralpha2-CAR T Cells) for the Treatment of Leptomeningeal Glioblastoma, Ependymoma, or Medulloblastoma
Ependymoma, Glioblastoma
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. This study is not recruiting at the moment.
Timothy Whelan, MD FRCPC principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fixed Gantry Radiosurgery and Robotic Radiosurgery in people with Metastatic Malignant Neoplasm to the Adult Brain, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey N Greenspoon, MD FRCPC ((905) 387-9495 ext. 64706, jeffrey.greenspoon@jcc.hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiosurgery planning and delivery time (time frame: 14 days). 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 NCT01353573, which also lists 7 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 13 May 2011.