NCT00973947

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 31, 2014

Status Verified

January 1, 2013

Enrollment Period

2.6 years

First QC Date

September 5, 2009

Last Update Submit

December 30, 2014

Conditions

Head and Neck Cancer

Keywords

stage I squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the larynxstage I verrucous carcinoma of the larynxstage II squamous cell carcinoma of the larynxstage II verrucous carcinoma of the larynxstage III squamous cell carcinoma of the larynxstage III verrucous carcinoma of the larynxstage IV squamous cell carcinoma of the larynxstage IV verrucous carcinoma of the larynxstage I adenoid cystic carcinoma of the oral cavitystage I mucoepidermoid carcinoma of the oral cavitystage I verrucous carcinoma of the oral cavitystage II adenoid cystic carcinoma of the oral cavitystage II mucoepidermoid carcinoma of the oral cavitystage II verrucous carcinoma of the oral cavitystage III adenoid cystic carcinoma of the oral cavitystage III mucoepidermoid carcinoma of the oral cavitystage III verrucous carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavitystage IV verrucous carcinoma of the oral cavitystage I squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage I basal cell carcinoma of the lipstage II basal cell carcinoma of the lipstage III basal cell carcinoma of the lipstage IV basal cell carcinoma of the lipmetastatic squamous neck cancer with occult primary squamous cell carcinomauntreated metastatic squamous neck cancer with occult primarystage I lymphoepithelioma of the nasopharynxstage I squamous cell carcinoma of the nasopharynxstage II lymphoepithelioma of the nasopharynxstage II squamous cell carcinoma of the nasopharynxstage III lymphoepithelioma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxstage I lymphoepithelioma of the oropharynxstage I squamous cell carcinoma of the oropharynxstage II lymphoepithelioma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage III lymphoepithelioma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the oropharynxstage I esthesioneuroblastoma of the paranasal sinus and nasal cavitystage I inverted papilloma of the paranasal sinus and nasal cavitystage I midline lethal granuloma of the paranasal sinus and nasal cavitystage I squamous cell carcinoma of the paranasal sinus and nasal cavitystage II esthesioneuroblastoma of the paranasal sinus and nasal cavitystage II inverted papilloma of the paranasal sinus and nasal cavitystage II midline lethal granuloma of the paranasal sinus and nasal cavitystage II squamous cell carcinoma of the paranasal sinus and nasal cavitystage III esthesioneuroblastoma of the paranasal sinus and nasal cavitystage III inverted papilloma of the paranasal sinus and nasal cavitystage III midline lethal granuloma of the paranasal sinus and nasal cavitystage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV esthesioneuroblastoma of the paranasal sinus and nasal cavitystage IV inverted papilloma of the paranasal sinus and nasal cavitystage IV midline lethal granuloma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavitystage I salivary gland cancerstage II salivary gland cancerstage III salivary gland cancerstage IV salivary gland cancerrecurrent lymphoepithelioma of the nasopharynxrecurrent lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent basal cell carcinoma of the liprecurrent adenoid cystic carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent verrucous carcinoma of the oral cavityrecurrent metastatic squamous neck cancer with occult primaryrecurrent esthesioneuroblastoma of the paranasal sinus and nasal cavityrecurrent inverted papilloma of the paranasal sinus and nasal cavityrecurrent midline lethal granuloma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent salivary gland cancer

Outcome Measures

Primary Outcomes (2)

  • Treatment set-up accuracy

    2010

  • Patient comfort with the two immobilization techniques as assessed by a patient-scored Visual Analogue Scale

    2010

Secondary Outcomes (2)

  • Radiation therapists' satisfaction as assessed by a questionnaire

    2010

  • Cost-effectiveness as assessed by resource implications of the two immobilization techniques

    2010

Study Arms (2)

Control

OTHER

Immobilisation: Standard headrest plus individual customised mask (orfit)

Other: questionnaire administrationRadiation: 3-dimensional conformal radiation therapyRadiation: radiation therapy treatment planning/simulation

TRial Arm

OTHER

Immobilisation: Customised headrest plus individual customised mask (orfit)

Other: questionnaire administrationRadiation: 3-dimensional conformal radiation therapyRadiation: radiation therapy treatment planning/simulation

Interventions

questionnaire administrationOTHER
ControlTRial Arm
3-dimensional conformal radiation therapyRADIATION
ControlTRial Arm
radiation therapy treatment planning/simulationRADIATION
ControlTRial Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Saint Luke's Hospital

Dublin, 6, Ireland

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, OlfactorySalivary Gland Neoplasms

Interventions

Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Pierre Thirion, MD

    Saint Luke's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2009

First Posted

September 9, 2009

Study Start

January 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

December 31, 2014

Record last verified: 2013-01

Locations

IE(1)