Side Effects of High-Dose Intensity-Modulated Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
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.
Head and Neck Cancer
Long-term Effects Secondary to Cancer Therapy in Adults
Oral Complications of Radiation Therapy
Procedure: adjuvant therapy
Procedure: management of therapy complications
Procedure: quality-of-life assessment
Radiation: intensity-modulated radiation therapy
|Official Title:||Evaluation of Normal Tissue Toxicities in Head and Neck Cancer Patients Receiving Intensity Modulated Radiotherapy (IMRT)|
- 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 ]
- 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 ]
|Study Start Date:||June 2004|
|Study Completion Date:||July 2007|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415025
|Study Chair:||Paul M. Harari, MD||University of Wisconsin, Madison|