NCT01353573

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

May 13, 2011

Status Verified

May 1, 2011

Enrollment Period

1 year

First QC Date

May 10, 2011

Last Update Submit

May 12, 2011

Conditions

Metastatic Malignant Neoplasm to the Adult Brain

Keywords

Brain NeoplasmsNeoplasm MetastasisNeoplasms

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Local Control

    One Year

  • Scattered Radiation Dose

    14 Days

  • Quality of Life

    One Year

  • Dosimetry

    7 Days

  • Acute Toxicity

    3 months

  • +1 more secondary outcomes

Study Arms (2)

Fixed Gantry Radiosurgery

ACTIVE COMPARATOR

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

Radiation: Fixed Gantry Radiosurgery

Robotic Radiosurgery

EXPERIMENTAL

Single fraction radiosurgery will be prescribed using a robotic linear accelerator

Radiation: Robotic Radiosurgery

Interventions

Fixed Gantry RadiosurgeryRADIATION

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

Also known as: Linear Accelerator Radiosurgery
Fixed Gantry Radiosurgery
Robotic RadiosurgeryRADIATION

Single fraction radiosurgery will be prescribed using a robotic radiosurgery system

Also known as: CyberKnife Radiosurgery
Robotic Radiosurgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • brain metastases from a confirmed primary extra-cranial site

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Related Publications (7)

  • 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.

    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.

    PMID: 19960231BACKGROUND

  • 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.

    PMID: 19190462RESULT

  • 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.

    PMID: 19184641RESULT

  • 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.

    PMID: 19783374RESULT

  • 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.

    PMID: 19516944RESULT

  • 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.

    PMID: 12925241RESULT

Related Links

MeSH Terms

Conditions

Brain NeoplasmsNeoplasm MetastasisNeoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Timothy Whelan, MD FRCPC

    Hamilton Health Sciences Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey N Greenspoon, MD FRCPC

CONTACT

(905) 387-9495jeffrey.greenspoon@jcc.hhsc.ca

Timothy Whelan, MD FRCPC

CONTACT

(905) 387-9495tim.whelan@jcc.hhsc.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2011

First Posted

May 13, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2013

Last Updated

May 13, 2011

Record last verified: 2011-05

Locations

CA(1)