Robotic Compared to Fixed Gantry Radiosurgery for Brain Metastases (TRICK)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Hamilton Health Sciences Corporation.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Ontario Clinical Oncology Group (OCOG)
Juravinski Cancer Centre Foundation
Information provided by:
Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01353573
First received: May 10, 2011
Last updated: May 12, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Metastatic Malignant Neoplasm to the Adult Brain
Radiation: Fixed Gantry Radiosurgery
Radiation: Robotic Radiosurgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Randomized Trial of Robotic Compared to Fixed Gantry Radiosurgery for Brain Metastases

Resource links provided by NLM:


Further study details as provided by Hamilton Health Sciences Corporation:

Primary Outcome Measures:
  • Radiosurgery planning and delivery time [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Local Control [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Local Control will be assesed using contrast enhanced MRI at 3,6 and 12 months after radiosurgery

  • Scattered Radiation Dose [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Thermo-luminescent dosimeters will be placed on the patient during treatment delivery to measure scatter radiation dose

  • Quality of Life [ Time Frame: One Year ] [ Designated as safety issue: No ]
    EQ-5D testing will be done prior to radiosurgery and at 4 weeks and at 3,6 and 12 months after radiosurgery

  • Dosimetry [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    Once the plan is approved all dosimetric measures will be recorded.

  • Acute Toxicity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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

  • Late Toxicity [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fixed Gantry Radiosurgery
Single fraction radiosurgery will be prescribed using a Fixed Gantry Linear Accelerator
Radiation: Fixed Gantry Radiosurgery
Single fraction radiosurgery will be prescribed using a fixed gantry radiosurgery delivery system
Other Name: Linear Accelerator Radiosurgery
Experimental: Robotic Radiosurgery
Single fraction radiosurgery will be prescribed using a robotic linear accelerator
Radiation: Robotic Radiosurgery
Single fraction radiosurgery will be prescribed using a robotic radiosurgery system
Other Name: CyberKnife Radiosurgery

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1-3 brain metastases from a confirmed primary extra-cranial site

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353573

Contacts
Contact: Jeffrey N Greenspoon, MD FRCPC (905) 387-9495 ext 64706 jeffrey.greenspoon@jcc.hhsc.ca
Contact: Timothy Whelan, MD FRCPC (905) 387-9495 ext 64701 tim.whelan@jcc.hhsc.ca

Locations
Canada, Ontario
Juravinski Cancer Centre Not yet recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Jeffrey N Greenspoon, MD FRCPC    (905) 387-9495 ext 64706    jeffrey.greenspoon@jcc.hhsc.ca   
Principal Investigator: Jeffrey N Greenspoon, MD FRCPC         
Principal Investigator: Anthony C Whitton, MD FRCPC         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Ontario Clinical Oncology Group (OCOG)
Juravinski Cancer Centre Foundation
Investigators
Principal Investigator: Timothy Whelan, MD FRCPC Hamilton Health Sciences Corporation
  More Information

Additional Information:
Publications:

Responsible Party: Dr. Jeffrey Noah Greenspoon Radiation Oncology Research Fellow, McMaster University
ClinicalTrials.gov Identifier: NCT01353573     History of Changes
Other Study ID Numbers: JNG-001
Study First Received: May 10, 2011
Last Updated: May 12, 2011
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by Hamilton Health Sciences Corporation:
Brain Neoplasms
Neoplasm Metastasis
Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014