Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatment intensity modulated radiotherapy treatment
Sponsor Stanford University
Collaborator Varian Medical Systems
Start date August 2011
End date January 2014
Trial size 30 participants
Trial identifier NCT01576939, ENT0032, IRB-21777, SU-08102011-8266

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.
intensity modulated radiotherapy treatment

Primary Outcomes

Measure
Feasibility of optimizing the IMRT plan based on dosimeter measurements of mucosal radiation dose adjacent to dental fillings
time frame: 2 years

Secondary Outcomes

Measure
Amount of radiation scattered to the adjacent mucosa (oral tongue and buccal) based on the type of dental filling
time frame: 2 years
Correlation of the mucosal surface dose as measured by the dosimeters to the time to onset and the duration of grade >= 2 mucositis during and after radiation completion.
time frame: 2 years
Correlation of the mucosal surface dose as measured by the dosimeters to the amount of narcotic use
time frame: 2 years
Correlation of the mucosal surface dose as measured by the dosimeters to the patient reported Mouth and Throat Soreness Score.
time frame: 2 years
Mucosal dose reduction amount on both sides in patients with bilateral metallic fillings.
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Feasibility Study of IMRT Modulation to Account for Scattered Radiation From Dental Fillings in Head and Neck Cancer Patients
Principal investigator Quynh-Thu Le, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Stanford University.