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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Varian Medical Systems
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01576939
First received: September 23, 2011
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Head and Neck Cancer
Radiation: intensity modulated radiotherapy treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study of IMRT Modulation to Account for Scattered Radiation From Dental Fillings in Head and Neck Cancer Patients

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Feasibility of optimizing the IMRT plan based on dosimeter measurements of mucosal radiation dose adjacent to dental fillings [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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?


Secondary Outcome Measures:
  • Amount of radiation scattered to the adjacent mucosa (oral tongue and buccal) based on the type of dental filling [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Correlation of the mucosal surface dose as measured by the dosimeters to the amount of narcotic use [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Correlation of the mucosal surface dose as measured by the dosimeters to the patient reported Mouth and Throat Soreness Score. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Mucosal dose reduction amount on both sides in patients with bilateral metallic fillings. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: May 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intensity modulated radiotherapy treatment
Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.
Radiation: intensity modulated radiotherapy treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576939

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Varian Medical Systems
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01576939     History of Changes
Other Study ID Numbers: ENT0032, SU-08102011-8266, 21777
Study First Received: September 23, 2011
Last Updated: April 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 23, 2014