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

Stanford University

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Radiation: Intensity Modulated Radiation Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01576939

IRB-21777

ENT0032 (Other Identifier)

SU-08102011-8266 (Other Identifier)

Details and patient eligibility

About

The main objective of this study is to determine the feasibility of optimizing the IMRT treatment plan based on dosimeter measurements of mucosal radiation dose adjacent to the dental fillings to reduce such dose to < 35 Gy without compromising tumor coverage and/or increasing the dose to the remaining oral cavity or nearby parotid glands.

Full description

Using radiation dosimeter, we will perform measurement of the doses received by the mucosa adjacent to the dental fillings in patients receiving IMRT for head and neck cancer. If the mucosa dose is estimated to be greater than 35 Gy for the entire radiation course, we will generate and implement a "filling" optimized IMRT plan, provided that this new plan does not compromise tumor coverage or increase dose to the rest of the oral mucosa or parotid glands. Dosimeter will be used to measure the mucosal dose delivered by this new IMRT plan. Patient's mucositis grade, narcotic use and self-reported mouth and throat soreness scores will be recorded and correlated to mucosal dose. We hypothesize that modulation of an IMRT plan to reduce the dose delivered to adjacent normal mucosa surrounding the dental filling can decrease the severity and duration of radiation-related oral mucositis. Here we propose to use thermoluminescent dosimeter (TLD) to measure the mucosal dose adjacent to the dental fillings in a standard, "non-filling" optimized IMRT plan that is normally delivered in the clinic.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with HNC undergoing radiation therapy +/- chemotherapy at Stanford University
• At least 18 years old
• Metallic filling present
• Planned radiation dose to the tumor > 60 Gy at 1.8 to 2.2 Gy/fx
• Able to understand and sign a written informed consent document.

Exclusion criteria

• Pregnant
• Nursing

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

IMRT Modulation

Experimental group

Description:

All patients will undergo a computed tomography (CT) simulation study +/- a positron emission tomography (PET) scan using ≤ 3mm slices for radiation treatment planning. A standard, "non-filling" optimized IMRT (Intensity Modulated Radiation Therapy) plan will be generated and patients will be treated with megavoltage radiation over a course of \> 6 weeks with a planned tumor dose of \> 60 Gy. A medical doctor will perform weekly mucositis evaluation and grading for the measured site once a week during radiation therapy Modulation of an IMRT plan to reduce the dose to less than 35 Gy delivered to adjacent normal mucosa surrounding the dental filling without compromising normal tissue or tumor doses.

Treatment:

Radiation: Intensity Modulated Radiation Therapy