Feasibility of IMRT Modulation to Account for Scattered Radiation From Dental Fillings in Head and Neck Cancer
This study is currently recruiting participants.
Verified October 2012 by Stanford University
Sponsor:
Stanford University
Collaborator:
Varian Medical Systems
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01576939
First received: September 23, 2011
Last updated: November 5, 2012
Last verified: October 2012
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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: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576939
Contacts
| Contact: Brian Khong | 650-725-4777 | bkhong1@stanford.edu |
Locations
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Brian Khong 650-725-4777 bkhong1@stanford.edu | |
| Contact: Cancer Clinical Trials Office (650) 498-7061 | |
| Principal Investigator: Quynh-Thu Le | |
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: | November 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013