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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415025
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : October 16, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date December 21, 2006
First Posted Date December 22, 2006
Last Update Posted Date October 16, 2015
Study Start Date June 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: October 13, 2007)
  • Stimulated saliva production at 6 months after completion of intensity-modulated radiotherapy (IMRT)
  • Comparison of salivary function of patients in current study to salivary function of historical controls
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00415025 on Archive Site
Current Secondary Outcome Measures
 (submitted: October 13, 2007)
  • Auditory, swallow, and voice function at 6 months after completion of IMRT
  • Quality of Life (QOL) as assessed at baseline and at 1, 6, and 12 months after completion of IMRT
  • Toxicities as measured by NCI CTCAE v3.0
  • Improvement in IMRT/tomotherapy field design
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title 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)
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



  • 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.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
  • Head and Neck Cancer
  • Long-term Effects Secondary to Cancer Therapy in Adults
  • Oral Complications of Radiation Therapy
  • Radiation Toxicity
  • Procedure: adjuvant therapy
  • Procedure: management of therapy complications
  • Procedure: quality-of-life assessment
  • Radiation: intensity-modulated radiation therapy
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: December 21, 2006)
Original Enrollment Same as current
Actual Study Completion Date July 2007
Primary Completion Date Not Provided
Eligibility Criteria


  • 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


  • No comorbid medical condition that would preclude radiotherapy
  • No serious concurrent psychosocial, familial, sociological, geographical, or other condition that would preclude study compliance


  • See Disease Characteristics
Sexes Eligible for Study: All
Ages 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
Administrative Information
NCT Number NCT00415025
Other Study ID Numbers H-2004-0168
P30CA014520 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor University of Wisconsin, Madison
Collaborators National Cancer Institute (NCI)
Study Chair: Paul M. Harari, MD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date October 2015