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

NCT ID: NCT00252473

Last Updated: 2010-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-06-30

Brief Summary

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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

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Conditions

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Head and Neck Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MedTec S-frame Immobilization Masks

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Princess Margaret Hospital, Canada

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Principal Investigators

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Andrew Bayley, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UHN REB 02-0832-C

Identifier Type: -

Identifier Source: org_study_id

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