Robotic Compared to Fixed Gantry Radiosurgery for Brain Metastases

NCT ID: NCT01353573

Last Updated: 2011-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-07-31

Brief 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. 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.

Conditions

Metastatic Malignant Neoplasm to the Adult Brain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Fixed Gantry Radiosurgery

Single fraction radiosurgery will be prescribed using a Fixed Gantry Linear Accelerator

Group Type: ACTIVE_COMPARATOR

Fixed Gantry Radiosurgery

Intervention Type: RADIATION

Single fraction radiosurgery will be prescribed using a fixed gantry radiosurgery delivery system

Robotic Radiosurgery

Single fraction radiosurgery will be prescribed using a robotic linear accelerator

Group Type: EXPERIMENTAL

Robotic Radiosurgery

Intervention Type: RADIATION

Single fraction radiosurgery will be prescribed using a robotic radiosurgery system

Interventions

Fixed Gantry Radiosurgery

Single fraction radiosurgery will be prescribed using a fixed gantry radiosurgery delivery system

Intervention Type: RADIATION

Robotic Radiosurgery

Single fraction radiosurgery will be prescribed using a robotic radiosurgery system

Intervention Type: RADIATION

Other Intervention Names

Linear Accelerator Radiosurgery; CyberKnife Radiosurgery

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role: collaborator

Juravinski Cancer Centre Foundation

OTHER

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

McMaster University

Principal Investigators

Timothy Whelan, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Locations

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Countries

Canada

Central Contacts

Jeffrey N Greenspoon, MD FRCPC

Role: CONTACT

jeffrey.greenspoon@jcc.hhsc.ca

(905) 387-9495 ext. 64706

Timothy Whelan, MD FRCPC

Role: CONTACT

tim.whelan@jcc.hhsc.ca

(905) 387-9495 ext. 64701

Facility Contacts

Jeffrey N Greenspoon, MD FRCPC

Role: primary

jeffrey.greenspoon@jcc.hhsc.ca

(905) 387-9495 ext. 64706

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 19960231 (View on PubMed)

Regis 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.

Reference Type: RESULT

PMID: 19190462 (View on PubMed)

Wowra 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.

Reference Type: RESULT

PMID: 19184641 (View on PubMed)

Blonigen 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.

Reference Type: RESULT

PMID: 19783374 (View on PubMed)

Gwak 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.

Reference Type: RESULT

PMID: 19516944 (View on PubMed)

Chang 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.

Reference Type: RESULT

PMID: 12925241 (View on PubMed)

Related Links

http://www.cyberknife.com

Robotic Radiosurgery System

http://www.varian.com

Fixed Gantry Radiosurgery System

Other Identifiers

JNG-001

Identifier Type: -

Identifier Source: org_study_id