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Completed

NCT Number: NCT00415025

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

adjuvant therapy

Procedure

management of therapy complications

Procedure

quality-of-life assessment

Procedure

Intensity-Modulated Radiation Therapy

Radiation

Primary outcomes

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

  2. Comparison of salivary function of patients in current study to salivary function of historical controls

Secondary outcomes

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

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

  3. Toxicities as measured by NCI CTCAE v3.0

  4. Improvement in IMRT/tomotherapy field design

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Evaluation of Normal Tissue Toxicities in Head and Neck Cancer Patients Receiving Intensity Modulated Radiotherapy (IMRT)

Important dates

Study start
2004
Study completion
2007
First posted
Dec 22, 2006
Registry last updated
Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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