Side Effects of High-Dose Intensity-Modulated Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Wisconsin, Madison
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00415025
First received: December 21, 2006
Last updated: May 9, 2009
Last verified: October 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 National Cancer Institute (NCI):
Primary Outcome Measures:
- Stimulated saliva production at 6 months after completion of intensity-modulated radiotherapy (IMRT) [ Designated as safety issue: No ]
- Comparison of salivary function of patients in current study to salivary function of historical controls [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Auditory, swallow, and voice function at 6 months after completion of IMRT [ Designated as safety issue: No ]
- Quality of Life (QOL) as assessed at baseline and at 1, 6, and 12 months after completion of IMRT [ Designated as safety issue: No ]
- Toxicities as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Improvement in IMRT/tomotherapy field design [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2004 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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 More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00415025 History of Changes |
| Obsolete Identifiers: | NCT00214188 |
| Other Study ID Numbers: | CDR0000515323, WCCC-RO-03313, WCCC-2004-0168 |
| Study First Received: | December 21, 2006 |
| Last Updated: | May 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
ClinicalTrials.gov processed this record on May 19, 2013