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A Feasibility Study of IMRT Modulation to Account for Scattered Radiation From Dental Fillings in Head and Neck Cancer Patients


N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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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 MedicineStanford, California  94305-5317