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

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00252473
First received: November 9, 2005
Last updated: August 12, 2010
Last verified: August 2010
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 25, 2014