Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415025
Status:
COMPLETED
Last Update Posted:
2015-10-16
First Post:
2006-12-21
Brief Title:
Side Effects of High-Dose Intensity-Modulated Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Evaluation of Normal Tissue Toxicities in Head and Neck Cancer Patients Receiving Intensity Modulated Radiotherapy IMRT
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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 IMRTtomotherapy 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
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 IMRTtomotherapy 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000515323 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA014520 |
| P30CA014520 | NIH | None | None |
| WCCC-RO-03313 | None | None | None |