Clinical trial NCT00415025: Side Effects of High-Dose Intensity-Modulated Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
Official title: Evaluation of Normal Tissue Toxicities in Head and Neck Cancer Patients Receiving Intensity Modulated Radiotherapy (IMRT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Long-term Effects Secondary to Cancer Therapy in Adults
Oral Complications of Radiation Therapy
Radiation Toxicity
Keywords: 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
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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 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

Primary outcomes:
measure: Stimulated saliva production at 6 months after completion of intensity-modulated radiotherapy (IMRT)
measure: Comparison of salivary function of patients in current study to salivary function of historical controls
Secondary outcomes:
measure: Auditory, swallow, and voice function at 6 months after completion of IMRT
measure: Quality of Life (QOL) as assessed at baseline and at 1, 6, and 12 months after completion of IMRT
measure: Toxicities as measured by NCI CTCAE v3.0
measure: Improvement in IMRT/tomotherapy field design
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Paul M. Harari, MD
role: STUDY_CHAIR
References: