Side Effects of High-Dose Intensity-Modulated Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer - Full Text View

Sponsors and Collaborators:	University of Wisconsin, Madison National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00415025

Purpose

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.

Condition	Intervention
Cancer-Related Problem/Condition Head and Neck Cancer	Procedure: adjuvant therapy Procedure: intensity-modulated radiation therapy Procedure: management of therapy complications Procedure: quality-of-life assessment

MedlinePlus related topics: Cancer Head and Neck Cancer Salivary Gland Disorders Tonsils and Adenoids

U.S. FDA Resources

Study Type:	Observational
Official Title:	Evaluation of Normal Tissue Toxicities in Head and Neck Cancer Patients Receiving Intensity Modulated Radiotherapy (IMRT)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Stimulated saliva production at 6 months after completion of intensity-modulated radiotherapy (IMRT) [ Designated as safety issue: No ]
Comparison of salivary function of patients in current study to salivary function of historical controls [ Designated as safety issue: No ]

Secondary Outcome Measures:

Auditory, swallow, and voice function at 6 months after completion of IMRT [ Designated as safety issue: No ]
Quality of Life (QOL) as assessed at baseline and at 1, 6, and 12 months after completion of IMRT [ Designated as safety issue: No ]
Toxicities as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Improvement in IMRT/tomotherapy field design [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	June 2004

Detailed Description:

OBJECTIVES:

Primary

Assess salivary function in patients with advanced head and neck cancer treated with intensity-modulated radiotherapy (IMRT) by measuring stimulated saliva production at 6 and 12 months after completion of therapy.
Compare salivary function in these patients to salivary function in historical controls.

Secondary

Assess auditory, swallow, and voice function and quality of life of these patients before and after IMRT or chemoradiotherapy.
Advance experience with IMRT/tomotherapy and improve field design for irradiating head and neck cancer in an effort to reduce radiation dose and minimize effects on surrounding normal tissue.

OUTLINE: This is a prospective study.

Patients undergo standard of care high-dose intensity-modulated radiotherapy (IMRT) to the head and neck.

Patients undergo baseline and post-treatment testing of auditory, salivary, swallow, and voice function as well as quality of life evaluation.

Patients are evaluated for radiation-induced toxicities at 1, 6, and 12 months after completion of IMRT.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415025

Sponsors and Collaborators

University of Wisconsin, Madison

National Cancer Institute (NCI)

Investigators

Study Chair:

Paul M. Harari, MD

University of Wisconsin, Madison

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000515323, WCCC-RO-03313, WCCC-2004-0168
Study First Received:	December 21, 2006
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00415025
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

long-term effects secondary to cancer therapy in adults
oral complications of radiation therapy
radiation toxicity
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
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 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 III basal cell carcinoma of the lip
stage III squamous cell carcinoma of the lip and oral cavity

stage IV basal cell carcinoma of the lip
stage IV squamous cell carcinoma of the lip and 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
metastatic squamous neck cancer with occult primary
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 III esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage III inverted papilloma of the paranasal sinus and nasal cavity

Study placed in the following topic categories:

Squamous cell carcinoma
Carcinoma, Basal Cell
Granuloma
Adenoid cystic carcinoma
Recurrence
Carcinoma
Epidermoid carcinoma
Nasopharyngeal carcinoma
Carcinoma, Adenoid Cystic

Metastatic squamous neck cancer with occult primary
Head and Neck Neoplasms
Neoplasm Metastasis
Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Carcinoma, Squamous Cell
Papilloma
Salivary Gland Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009