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

May 12, 2011 updated by: Hamilton Health Sciences Corporation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • CyberKnife Radiosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Control
Time Frame: One Year
Local Control will be assesed using contrast enhanced MRI at 3,6 and 12 months after radiosurgery
One Year
Scattered Radiation Dose
Time Frame: 14 Days
Thermo-luminescent dosimeters will be placed on the patient during treatment delivery to measure scatter radiation dose
14 Days
Quality of Life
Time Frame: One Year
EQ-5D testing will be done prior to radiosurgery and at 4 weeks and at 3,6 and 12 months after radiosurgery
One Year
Dosimetry
Time Frame: 7 Days
Once the plan is approved all dosimetric measures will be recorded.
7 Days
Acute Toxicity
Time Frame: 3 months
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
3 months
Late Toxicity
Time Frame: One Year
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.
One Year

Collaborators and Investigators

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

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Ontario Clinical Oncology Group (OCOG)
Juravinski Cancer Centre Foundation

Investigators

  • Principal Investigator: Timothy Whelan, MD FRCPC, Hamilton Health Sciences Corporation

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

Helpful Links

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

July 1, 2011

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

May 12, 2011

First Posted (Estimate)

May 13, 2011

Study Record Updates

Last Update Posted (Estimate)

May 13, 2011

Last Update Submitted That Met QC Criteria

May 12, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JNG-001

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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