N/A
N=30
Feasibility of IMRT Modulation to Account for Scattered Radiation From Dental Fillings in Head and Neck Cancer
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01576939 ↗Enrolled (actual)
30
Serious AEs
36.7%
Results posted
Jun 2017
Primary outcome: Primary: Time Until the Maximum Oral Mucositis Measured From the Start of Radiation Treatment. — 34; 29 Days — p=0.9906
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intensity Modulated Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Until the Maximum Oral Mucositis Measured From the Start of Radiation Treatment. |
34; 29 | 0.9906 |
| PRIMARY Duration of Grade 2 or Higher Oral Mucositis After First Oral Mucositis Was Observed. |
25.722; 27.917 | 0.1209 |
| SECONDARY Relationship Between the Measured Lateral Tongue Mucosal Dose and the Amount of Narcotic Use |
917.5; 1214.3 | 0.9832 |
| SECONDARY How Does Increase in Soreness Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose |
2.908; 3.689 | 0.0263 sig |
| SECONDARY How Does Increase in Pain Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose? |
2.28; 3.292 | 0.0039 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT01576939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.