NCT00328510

Brief Summary

Fractionated stereotactic radiotherapy (SRT) requires extremely precise and reproducible immobilization of the patient's head. This randomized study compares the efficacy of two commonly used forms of immobilization used for SRT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
4 years until next milestone

Results Posted

Study results publicly available

August 19, 2013

Completed
Last Updated

November 29, 2016

Status Verified

October 1, 2016

Enrollment Period

2.9 years

First QC Date

May 19, 2006

Results QC Date

April 30, 2013

Last Update Submit

October 19, 2016

Conditions

Patients Receiving Fractionated Stereotactic Radiotherapyfor Brain Tumors

Keywords

Stereotactic radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability

    This study uses the ExacTRAC imaging system to assess positioning of frame or mask during SRT. Images yield lateral, longitudinal, and vertical deviations of the isocenter as well as head rotations about respective axes.

    Measurements taken during SRT

Study Arms (2)

GTC Frame

EXPERIMENTAL

Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy

Device: GTC frameRadiation: Stereotactic radiation therapy

BrainLab thermoplastic mask

EXPERIMENTAL

Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy

Device: Thermoplastic facemaskRadiation: Stereotactic radiation therapy

Interventions

GTC frameDEVICE
GTC Frame
Thermoplastic facemaskDEVICE
BrainLab thermoplastic mask
Stereotactic radiation therapyRADIATION
Also known as: SRT
BrainLab thermoplastic maskGTC Frame

Eligibility Criteria

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

You may qualify if:

  • Patients who are eligible for fractionated stereotactic radiotherapy

You may not qualify if:

  • Severe claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (3)

  • Shiu A, Parker B, Ye JS, Lii J. An integrated treatment delivery system for CSRS and CSRT and clinical applications. J Appl Clin Med Phys. 2003 Autumn;4(4):261-73. doi: 10.1120/jacmp.v4i4.2496.

    PMID: 14604415BACKGROUND

  • Burton KE, Thomas SJ, Whitney D, Routsis DS, Benson RJ, Burnet NG. Accuracy of a relocatable stereotactic radiotherapy head frame evaluated by use of a depth helmet. Clin Oncol (R Coll Radiol). 2002 Feb;14(1):31-9. doi: 10.1053/clon.2001.0001.

    PMID: 11898783BACKGROUND

  • Lopatta E, Liesenfeld SM, Bank P, Wurm R, Gunther R, Wiezorek T, Wendt TG. [Improved patient repositioning accuracy by integrating an additional jaw fixation into a high precision face mask system in stereotactic radiotherapy of the head]. Strahlenther Onkol. 2003 Aug;179(8):571-5. doi: 10.1007/s00066-003-0941-3. German.

    PMID: 14509957BACKGROUND

Related Links

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Results Point of Contact

Title
Maria Werner-Wasik, MD
Organization
Thomas Jefferson University
Maria.Werner-Wasik@jeffersonhospital.org
215-955-7679

Study Officials

  • Maria Werner-Wasik, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2006

First Posted

May 22, 2006

Study Start

February 1, 2005

Primary Completion

January 1, 2008

Study Completion

September 1, 2009

Last Updated

November 29, 2016

Results First Posted

August 19, 2013

Record last verified: 2016-10

Locations

US(1)