S-Frame CT Immobilization Masks For Patients Undergoing Radiation Therapy For Head and Neck Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

November 9, 2005

Last Updated Date

February 10, 2006

Start Date ^ICMJE

January 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Measurement of the accuracy of MedTec S-frame head and neck immobilization system (isocentre set-up accuracy, patient movement margins and movement of the normal tissue critical structures and planning target volumes)

Original Primary Outcome Measures ^ICMJE

Measurement of the accuracy of MedTec S-frame head and neck immobilization system.(Isocentre setup accuracy, patient movement margins and movement of the normal tissue critical structures and planning target volumes)

Change History

Complete list of historical versions of study NCT00252473 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

S-Frame CT Immobilization Masks For Patients Undergoing Radiation Therapy For Head and Neck Cancer

Official Title ^ICMJE

Evaluation of Setup Accuracy in Med Tec S-Frame Immobilization Masks For Patients Undergoing Radiation Therapy For Head and Neck Cancer

Brief Summary

Immobilization devices such as thermoplastic masks are used routinely in the radiation treatment of head and neck cancer patients. It is important to assess how well they function at preventing patient motion while the radiation treatment is being delivered. (i.e. isocentre set-up margins, patient motion with the mask). If these new thermoplastic masks such as MedTec S-frame allow less movement, then smaller margins are needed during radiation therapy which, in turn, would decrease side effects from the treatment.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Head and Neck Neoplasms

Intervention ^ICMJE

Device: MedTec S-frame Immobilization Masks

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histological confirmation of mucosal malignancy in the head and neck (H&N) region
Undergoing radiotherapy (RT) with curative intent using a lateral parallel pair treatment with an anterior or anterior/posterior low neck filed technique using a MedTec S-frame mask

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Andrew Bayley, MD

416-946-2919

andrew.bayley@rmp.uhn.on.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00252473

Responsible Party

Study ID Numbers ^ICMJE

UHN REB 02-0832-C

Study Sponsor ^ICMJE

University Health Network, Toronto

Collaborators ^ICMJE

Princess Margaret Hospital, Canada

Investigators ^ICMJE

Principal Investigator:

Andrew Bayley, MD

Princess Margaret Hospital, Canada

Information Provided By

University Health Network, Toronto

Verification Date

October 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP