Evaluation of Normal Tissue Toxicities in Head and Neck Cancer Patients Receiving Intensity Modulated Radiotherapy (IMRT)
18 Years
N/A
Both
Head and Neck Cancer, Long-Term Effects Secondary to Cancer Therapy in Adults, Oral Complications of Radiation Therapy, Radiation Toxicity
Trial Information
Evaluation of Normal Tissue Toxicities in Head and Neck Cancer Patients Receiving Intensity Modulated Radiotherapy (IMRT)
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.
Inclusion 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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Stimulated saliva production at 6 months after completion of intensity-modulated radiotherapy (IMRT)
Safety Issue:
No
Principal Investigator
Paul M. Harari, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Federal Government
Study ID:
CDR0000515323
NCT ID:
NCT00415025
Start Date:
June 2004
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Long-term Effects Secondary to Cancer Therapy in Adults
- Oral Complications of Radiation Therapy
- Radiation Toxicity
- 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
- 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 III salivary gland cancer
- stage IV salivary gland cancer
- recurrent 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 larynx
- recurrent squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the oropharynx
- recurrent verrucous carcinoma of the larynx
- recurrent adenoid cystic carcinoma of the oral cavity
- recurrent mucoepidermoid carcinoma of the oral cavity
- recurrent verrucous carcinoma of the oral cavity
- 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 basal cell carcinoma of the lip
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent metastatic squamous neck cancer with occult primary
- untreated metastatic squamous neck cancer with occult primary
- Head and Neck Neoplasms
- Radiation Injuries
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