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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00415025
First Posted: December 22, 2006
Last Update Posted: October 16, 2015
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose

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.


Condition Intervention
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 Type: Observational
Official Title: Evaluation of Normal Tissue Toxicities in Head and Neck Cancer Patients Receiving Intensity Modulated Radiotherapy (IMRT)

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 20
Study Start Date: June 2004
Study Completion Date: July 2007
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00415025


Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Investigators
Study Chair: Paul M. Harari, MD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00415025     History of Changes
Obsolete Identifiers: NCT00214188
Other Study ID Numbers: H-2004-0168
P30CA014520 ( U.S. NIH Grant/Contract )
WCCC-RO-03313
CDR0000515323
First Submitted: December 21, 2006
First Posted: December 22, 2006
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by University of Wisconsin, Madison:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Radiation Injuries
Neoplasms by Site
Neoplasms
Wounds and Injuries