NCT00415025

Brief Summary

RATIONALE: Tests that measure how much saliva is made, hearing, swallowing, voice function, and quality of life may improve the ability to plan treatment for patients with advanced head and neck cancer and may help doctors find better ways to treat the cancer. PURPOSE: This clinical trial is studying the side effects of high-dose intensity-modulated radiation therapy in treating patients with advanced head and neck cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2004

Typical duration for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

First QC Date

December 21, 2006

Last Update Submit

October 15, 2015

Conditions

Head and Neck CancerLong-term Effects Secondary to Cancer Therapy in AdultsOral Complications of Radiation TherapyRadiation Toxicity

Keywords

long-term effects secondary to cancer therapy in adultsoral complications of radiation therapyradiation toxicitystage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxstage 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 III lymphoepithelioma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the oropharynxstage III basal cell carcinoma of the lipstage III squamous cell carcinoma of the lip and oral cavitystage IV basal cell carcinoma of the lipstage IV squamous cell carcinoma of the lip and 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 cavitymetastatic squamous neck cancer with occult primarystage III lymphoepithelioma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxstage 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 III salivary gland cancerstage IV salivary gland cancerrecurrent salivary gland cancerrecurrent lymphoepithelioma of the nasopharynxrecurrent lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the oropharynxrecurrent verrucous carcinoma of the larynxrecurrent adenoid cystic carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent verrucous carcinoma of the oral cavityrecurrent 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 basal cell carcinoma of the liprecurrent squamous cell carcinoma of the lip and oral cavityrecurrent metastatic squamous neck cancer with occult primaryuntreated metastatic squamous neck cancer with occult primary

Outcome Measures

Primary Outcomes (2)

  • Stimulated saliva production at 6 months after completion of intensity-modulated radiotherapy (IMRT)

  • Comparison of salivary function of patients in current study to salivary function of historical controls

Secondary Outcomes (4)

  • Auditory, swallow, and voice function at 6 months after completion of IMRT

  • Quality of Life (QOL) as assessed at baseline and at 1, 6, and 12 months after completion of IMRT

  • Toxicities as measured by NCI CTCAE v3.0

  • Improvement in IMRT/tomotherapy field design

Interventions

adjuvant therapyPROCEDURE
management of therapy complicationsPROCEDURE
quality-of-life assessmentPROCEDURE
intensity-modulated radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed advanced head and neck cancer * Indication for radiotherapy or chemoradiotherapy as primary or postoperative therapy AND meets 1 of the following criteria: * More than 75% of bilateral parotid glands expected to receive ≥ 45 cGy of radiation using conventional treatment field design * Either or both central auditory apparatus predicted to receive \> 45 cGy of radiation PATIENT CHARACTERISTICS: * No comorbid medical condition that would preclude radiotherapy * No serious concurrent psychosocial, familial, sociological, geographical, or other condition that would preclude study compliance 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

MeSH Terms

Conditions

Head and Neck NeoplasmsRadiation InjuriesSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, OlfactorySalivary Gland Neoplasms

Interventions

Chemotherapy, AdjuvantRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsWounds and InjuriesCarcinoma, 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)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapy

Study Officials

  • Paul M. Harari, MD

    University of Wisconsin, Madison

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 22, 2006

Study Start

June 1, 2004

Study Completion

July 1, 2007

Last Updated

October 16, 2015

Record last verified: 2015-10