A Feasibility Study of IMRT Modulation to Account for Scattered Radiation From Dental Fillings in Head and Neck Cancer Patients
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
A Feasibility Study of IMRT Modulation to Account for Scattered Radiation From Dental Fillings in Head and Neck Cancer Patients
Inclusion Criteria:
- Patients with HNC undergoing radiation therapy +/- chemotherapy at Stanford
University
- Age >= 18 years old
- Metallic filling present
- Planned radiation dose to the tumor > 60 Gy at 1.8-2.2 Gy/fx
- Able to understand and sign a written informed consent document.
Exclusion Criteria:
- Patients who are pregnant or nursing, which preclude them from undergoing active
radiation treatment.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility of optimizing the IMRT plan based on dosimeter measurements of mucosal radiation dose adjacent to dental fillings
Outcome Description:
The primary end point will check if it is feasible to optimize the IMRT plan based on dosimeter measurements of mucosal radiation dose adjacent to the dental fillings to reduce such dose to < 35 Gy without compromising dose to the tumor and the remainder oral cavity and if so, the feasibility of this approach in what proportion of patients and with what characteristics?
Outcome Time Frame:
2 years
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
ENT0032
NCT ID:
NCT01576939
Start Date:
August 2011
Completion Date:
August 2013
Related Keywords:
- Head and Neck Cancer
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Stanford University School of Medicine | Stanford, California 94305-5317 |
