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S-Frame CT Immobilization Masks For Patients Undergoing Radiation Therapy For Head and Neck Cancer
This study is currently recruiting participants.
Verified by University Health Network, Toronto, October 2005
First Received: November 9, 2005   Last Updated: February 10, 2006   History of Changes
Sponsors and Collaborators: University Health Network, Toronto
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: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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:


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
  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

Contacts
Contact: Andrew Bayley, MD 416-946-2919 andrew.bayley@rmp.uhn.on.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Andrew Bayley, MD     416-946-2919     andrew.bayley@rmp.uhn.on.ca    
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

Study ID Numbers: UHN REB 02-0832-C
Study First Received: November 9, 2005
Last Updated: February 10, 2006
ClinicalTrials.gov Identifier: NCT00252473     History of Changes
Health Authority: Canada: Ethics Review Committee

Study placed in the following topic categories:
Head and Neck Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on July 06, 2009