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

This study has been completed.

First Received on November 9, 2005. Last Updated on August 12, 2010 History of Changes

Sponsor:	University Health Network, Toronto
Collaborator:	Princess Margaret Hospital, Canada
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00252473

Purpose

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.

Condition	Intervention	Phase
Head and Neck Neoplasms	Device: MedTec S-frame Immobilization Masks	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of Setup Accuracy in Med Tec S-Frame Immobilization Masks For Patients Undergoing Radiation Therapy For Head and Neck Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

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)

Estimated Enrollment:	30
Study Start Date:	January 2005
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252473

Locations

Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto

Princess Margaret Hospital, Canada

Investigators

Principal Investigator:

Andrew Bayley, MD

Princess Margaret Hospital, Canada

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00252473 History of Changes
Other Study ID Numbers:	UHN REB 02-0832-C
Study First Received:	November 9, 2005
Last Updated:	August 12, 2010
Health Authority:	Canada: Ethics Review Committee

Additional relevant MeSH terms:

Neoplasms
Head and Neck Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on February 13, 2012