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

Head and Neck Cancer Clinical Trial

Official title:

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

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
• 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

• Head and Neck Cancer
• Head and Neck Neoplasms
• Long-term Effects Secondary to Cancer Therapy in Adults
• Oral Complications of Radiation Therapy
• Radiation Injuries
• Radiation Toxicity

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