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Customized Headrest or Standard Headrest in Holding Patients Still While Undergoing Radiation Therapy for Head and Neck Cancer

NCT ID: NCT00973947

Last Updated: 2014-12-31

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

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-08-31

Brief Summary

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RATIONALE: Using a customized headrest to hold patients in one position may help doctors plan treatment for patients with head and neck cancer. It is not yet known whether a customized headrest is more effective than a standard headrest in holding patients still during radiation therapy.

PURPOSE: This randomized clinical trial is studying a customized headrest to see how well it works compared with a standard headrest in holding patients still while undergoing radiation therapy for head and neck cancer.

Detailed Description

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OBJECTIVES:

Primary

* To evaluate and compare the treatment set-up accuracy of customized vs standard headrest in immobilizing patients undergoing radiotherapy for head and neck cancer.
* To determine and compare patient comfort with the two immobilization techniques.

Secondary

* To evaluate radiation therapists' satisfaction with the two immobilization techniques.
* To examine and compare the cost effectiveness of the two immobilization techniques.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.

* Arm I: Patients are immobilized using the standard thermoplastic four-point fixation mask and the standard headrest system. Patients undergo 3-dimensional conformal radiotherapy as per standard of care.
* Arm II: Patients are immobilized using the standard thermoplastic four-point fixation mask and the customized headrest system. Patients undergo 3-dimensional conformal radiotherapy as per standard of care.

Patients score their comfort using the Visual Analogue Scale during the course of radiotherapy. Radiation therapists complete an evaluation questionnaire for each treatment planning and procedure.

Conditions

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Head and Neck Cancer

Keywords

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stage I squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage I squamous cell carcinoma of the larynx stage I verrucous carcinoma of the larynx stage II squamous cell carcinoma of the larynx stage II verrucous carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage III verrucous carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage IV verrucous carcinoma of the larynx stage I adenoid cystic carcinoma of the oral cavity stage I mucoepidermoid carcinoma of the oral cavity stage I verrucous carcinoma of the oral cavity stage II adenoid cystic carcinoma of the oral cavity stage II mucoepidermoid carcinoma of the oral cavity stage II verrucous carcinoma of the oral cavity stage III adenoid cystic carcinoma of the oral cavity stage III mucoepidermoid carcinoma of the oral cavity stage III verrucous carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity stage IV mucoepidermoid carcinoma of the oral cavity stage IV verrucous carcinoma of the oral cavity stage I squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage I basal cell carcinoma of the lip stage II basal cell carcinoma of the lip stage III basal cell carcinoma of the lip stage IV basal cell carcinoma of the lip metastatic squamous neck cancer with occult primary squamous cell carcinoma untreated metastatic squamous neck cancer with occult primary stage I lymphoepithelioma of the nasopharynx stage I squamous cell carcinoma of the nasopharynx stage II lymphoepithelioma of the nasopharynx stage II squamous cell carcinoma of the nasopharynx stage III lymphoepithelioma of the nasopharynx stage III squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx stage I lymphoepithelioma of the oropharynx stage I squamous cell carcinoma of the oropharynx stage II lymphoepithelioma of the oropharynx stage II squamous cell carcinoma of the oropharynx stage III lymphoepithelioma of the oropharynx stage III squamous cell carcinoma of the oropharynx stage IV lymphoepithelioma of the oropharynx stage IV squamous cell carcinoma of the oropharynx stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity stage I inverted papilloma of the paranasal sinus and nasal cavity stage I midline lethal granuloma of the paranasal sinus and nasal cavity stage I squamous cell carcinoma of the paranasal sinus and nasal cavity stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity stage II inverted papilloma of the paranasal sinus and nasal cavity stage II midline lethal granuloma of the paranasal sinus and nasal cavity stage II squamous cell carcinoma of the paranasal sinus and nasal cavity stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity stage III inverted papilloma of the paranasal sinus and nasal cavity stage III midline lethal granuloma of the paranasal sinus and nasal cavity stage III squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity stage IV inverted papilloma of the paranasal sinus and nasal cavity stage IV midline lethal granuloma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity stage I salivary gland cancer stage II salivary gland cancer stage III salivary gland cancer stage IV salivary gland cancer recurrent lymphoepithelioma of the nasopharynx recurrent lymphoepithelioma of the oropharynx recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity recurrent basal cell carcinoma of the lip recurrent adenoid cystic carcinoma of the oral cavity recurrent mucoepidermoid carcinoma of the oral cavity recurrent verrucous carcinoma of the oral cavity recurrent metastatic squamous neck cancer with occult primary recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity recurrent inverted papilloma of the paranasal sinus and nasal cavity recurrent midline lethal granuloma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent salivary gland cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Immobilisation: Standard headrest plus individual customised mask (orfit)

Group Type OTHER

questionnaire administration

Intervention Type OTHER

3-dimensional conformal radiation therapy

Intervention Type RADIATION

radiation therapy treatment planning/simulation

Intervention Type RADIATION

TRial Arm

Immobilisation: Customised headrest plus individual customised mask (orfit)

Group Type OTHER

questionnaire administration

Intervention Type OTHER

3-dimensional conformal radiation therapy

Intervention Type RADIATION

radiation therapy treatment planning/simulation

Intervention Type RADIATION

Interventions

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questionnaire administration

Intervention Type OTHER

3-dimensional conformal radiation therapy

Intervention Type RADIATION

radiation therapy treatment planning/simulation

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed head and neck malignancy
* Planning to undergo radical 3-dimensional conformal radiotherapy (using the Oncentra MasterPlan treatment planning system) at St Luke's Hospital

PATIENT CHARACTERISTICS:

* No evidence of any other significant clinical disorder or laboratory finding that would make it undesirable for the patient to participate in the study
* Able to comply with the study, in the opinion of the researcher and/or medical team

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Trials Ireland

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Thirion, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Luke's Hospital

Locations

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Saint Luke's Hospital

Dublin, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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ICORG-08-09

Identifier Type: -

Identifier Source: secondary_id

EU-20954

Identifier Type: -

Identifier Source: secondary_id

08-09 ICORG

Identifier Type: -

Identifier Source: org_study_id