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

NCT ID: NCT01576939

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2016-04-30

Brief Summary

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.

Detailed 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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMRT Modulation

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.

Group Type: EXPERIMENTAL

Intensity Modulated Radiation Therapy

Intervention Type: RADIATION

We are using thermoluminescent dosimeter (TLD) to measure the mucosal dose adjacent to the dental fillings in a standard, "non-filling" optimized IMRT (intensity modulated radiotherapy treatment) plan that is normally delivered in the clinic. If the measured mucosal dose exceeds 35 Gy, we will generate a "filling" optimized IMRT plan to reduce it to \< 35 Gy. The new plan will be deemed acceptable and implemented only if it does not (1) compromise the tumor coverage, (2) increase the dose to either the remaining oral cavity or the spared parotid gland(s).

Interventions

Intensity Modulated Radiation Therapy

We are using thermoluminescent dosimeter (TLD) to measure the mucosal dose adjacent to the dental fillings in a standard, "non-filling" optimized IMRT (intensity modulated radiotherapy treatment) plan that is normally delivered in the clinic. If the measured mucosal dose exceeds 35 Gy, we will generate a "filling" optimized IMRT plan to reduce it to \< 35 Gy. The new plan will be deemed acceptable and implemented only if it does not (1) compromise the tumor coverage, (2) increase the dose to either the remaining oral cavity or the spared parotid gland(s).

Intervention Type: RADIATION

Other Intervention Names

IMRT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Varian Medical Systems

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Quynh-Thu Le

Professor of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Quynh-Thu Le, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Radiation Oncology

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

SU-08102011-8266

Identifier Type: OTHER

Identifier Source: secondary_id

ENT0032

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-21777

Identifier Type: -

Identifier Source: org_study_id