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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00415025
Other study ID # H-2004-0168
Secondary ID P30CA014520WCCC-
Status Completed
Phase N/A
First received December 21, 2006
Last updated October 15, 2015
Start date June 2004
Est. completion date July 2007

Study information

Verified date October 2015
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT00214188

Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 120 Years
Eligibility 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

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Procedure:
adjuvant therapy

management of therapy complications

quality-of-life assessment

Radiation:
intensity-modulated radiation therapy


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison National Cancer Institute (NCI)

Outcome

Type Measure Description Time frame Safety issue
Primary Stimulated saliva production at 6 months after completion of intensity-modulated radiotherapy (IMRT) No
Primary Comparison of salivary function of patients in current study to salivary function of historical controls No
Secondary Auditory, swallow, and voice function at 6 months after completion of IMRT No
Secondary Quality of Life (QOL) as assessed at baseline and at 1, 6, and 12 months after completion of IMRT No
Secondary Toxicities as measured by NCI CTCAE v3.0 Yes
Secondary Improvement in IMRT/tomotherapy field design No
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