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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01576939
• Other study ID #: IRB-21777
• Secondary ID: SU-08102011-8266
• Status: Active, not recruiting
• Phase: N/A
• First received: September 23, 2011
• Last updated: May 20, 2015
• Start date: August 2011
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• intensity modulated radiotherapy treatment

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of optimizing the IMRT plan based on dosimeter measurements of mucosal radiation dose adjacent to dental fillings	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?	2 years	No
Secondary	Amount of radiation scattered to the adjacent mucosa (oral tongue and buccal) based on the type of dental filling		2 years	No
Secondary	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.		2 years	No
Secondary	Correlation of the mucosal surface dose as measured by the dosimeters to the amount of narcotic use		2 years	No
Secondary	Correlation of the mucosal surface dose as measured by the dosimeters to the patient reported Mouth and Throat Soreness Score.		2 years	No
Secondary	Mucosal dose reduction amount on both sides in patients with bilateral metallic fillings.		2 years	No