Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426504
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2007-01-23
Brief Title:
Radiation Therapy Using Helical Tomotherapy IMRT for Head and Neck Cancer
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
Helical Tomotherapy Intensity Modulated RadiotherapyA Phase III Pilot Study to Determine the Toxicity Profile Pattern of Failures and Quality of Life of Patients With Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2020-03
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:
Historically patients with stage III and IV head and neck cancer have been treated with surgery andor radiation therapy Based on the results of recent clinical trials in patients not able to undergo surgery chemotherapy with radiation therapy has been adopted as the current standard of care The chemo-radiation approach however entails a significant increase in treatment-related toxicity limiting the extent to which this treatment can be offered to patients In this trial the ability of a new form of radiation therapy delivery called IMRT will be evaluated for its ability to reduce the amount of radiation-induced toxicity
Detailed Description:
The mechanisms of action to explain the radiation-induced toxic effects resulting from the more aggressive radiation therapy treatments of head and neck cancer include the additive and synergistic increase in mucositis from the combination of chemotherapy and radiotherapy The severe toxicity associated with more aggressive radiation therapy treatments for locoregional head and neck cancer limits the extent to which these treatments can be offered since many patients present with nutritional deficiencies and consequent general debility Intensity Modulated Radiotherapy IMRT is a technology has the potential for exquisite dose painting and structuring in such a manner that it can permit exclusion of normal tissues and sensitive structures from the high dose radiation volume without compromising primary tumor or nodal target coverage In this phase III feasibility trial radical radiotherapy will be delivered using Helical Tomotherapy Intensity Modulated Radiotherapy HT-IMRT to a dose of 66-70 Gy to involved areas and to at least 50 Gy to un-involved sites treated prophylactically It is hypothesized that the pattern of failure and toxicity profiles of patients treated with helical tomotherapy will demonstrate the greater efficacy of helical tomotherapy as compared with conventional radiotherapy in the treatment of cancers of the head and neck
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OTT 05-06 | OTHER | OHRI | None |