Robotic Compared to Fixed Gantry Radiosurgery for Brain Metastases

Metastatic Malignant Neoplasm to the Adult Brain Clinical Trial

— TRICK  

Official title:

A Randomized Trial of Robotic Compared to Fixed Gantry Radiosurgery for Brain Metastases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01353573
• Other study ID #: JNG-001
• Status: Not yet recruiting
• Phase: Phase 3
• First received: May 10, 2011
• Last updated: May 12, 2011
• Start date: July 2011
• Est. completion date: July 2013

Study information

• Verified date: May 2011
• Source: Hamilton Health Sciences Corporation
• Contact: Jeffrey N Greenspoon, MD FRCPC
• Phone: (905) 387-9495
• Email: jeffrey.greenspoon[@]jcc.hhsc.ca
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Metastatic Malignant Neoplasm to the Adult Brain
• Neoplasms
• Neoplasms, Second Primary

Intervention

Radiation:
• Fixed Gantry Radiosurgery
Single fraction radiosurgery will be prescribed using a fixed gantry radiosurgery delivery system
• Robotic Radiosurgery
Single fraction radiosurgery will be prescribed using a robotic radiosurgery system

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Juravinski Cancer Centre Foundation, Ontario Clinical Oncology Group (OCOG)

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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.ijr — View Citation

Canadian Agency for Drugs and Technologies in Health (CADTH). TomoTherapy, Gamma Knife, 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. CADTH Technol Overv. 2010;1(3):e0119. Epub 2010 Sep 1. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Régis 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 Gam — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	14 days	No
Secondary	Local Control	Local Control will be assesed using contrast enhanced MRI at 3,6 and 12 months after radiosurgery	One Year	No
Secondary	Scattered Radiation Dose	Thermo-luminescent dosimeters will be placed on the patient during treatment delivery to measure scatter radiation dose	14 Days	Yes
Secondary	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	One Year	No
Secondary	Dosimetry	Once the plan is approved all dosimetric measures will be recorded.	7 Days	No
Secondary	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	3 months	Yes
Secondary	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.	One Year	Yes

External Links

•   Fixed Gantry Radiosurgery System
•   Robotic Radiosurgery System