A Feasibility Study of IMRT (Intensity Modulated Radiotherapy) Modulation to Account for Scattered Radiation From Dental Fillings in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time Until the Maximum Oral Mucositis Measured From the Start of Radiation Treatment.
研究概览
简要总结
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.
详细描述
Using radiation dosimeter, we will perform measurement of the doses received by the mucosa adjacent to the dental fillings in patients receiving IMRT for head and neck cancer. If the mucosa dose is estimated to be greater than 35 Gy for the entire radiation course, we will generate and implement a "filling" optimized IMRT plan, provided that this new plan does not compromise tumor coverage or increase dose to the rest of the oral mucosa or parotid glands. Dosimeter will be used to measure the mucosal dose delivered by this new IMRT plan. Patient's mucositis grade, narcotic use and self-reported mouth and throat soreness scores will be recorded and correlated to mucosal dose. We hypothesize that modulation of an IMRT plan to reduce the dose delivered to adjacent normal mucosa surrounding the dental filling can decrease the severity and duration of radiation-related oral mucositis. Here we propose to use thermoluminescent dosimeter (TLD) to measure the mucosal dose adjacent to the dental fillings in a standard, "non-filling" optimized IMRT plan that is normally delivered in the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
IMRT Modulation
All patients will undergo a computed tomography (CT) simulation study +/- a positron emission tomography (PET) scan using ≤ 3mm slices for radiation treatment planning. A standard, "non-filling" optimized IMRT (Intensity Modulated Radiation Therapy) plan will be generated and patients will be treated with megavoltage radiation over a course of > 6 weeks with a planned tumor dose of > 60 Gy. A medical doctor will perform weekly mucositis evaluation and grading for the measured site once a week during radiation therapy
Modulation of an IMRT plan to reduce the dose to less than 35 Gy delivered to adjacent normal mucosa surrounding the dental filling without compromising normal tissue or tumor doses.
干预措施: Intensity Modulated Radiation Therapy (Radiation)
结局指标
主要结局
Time Until the Maximum Oral Mucositis Measured From the Start of Radiation Treatment.
时间窗: 3 years
The time to onset of oral mucositis was measured from the start of radiation treatment until oral mucositis was visual observed by a clinician during the weekly checkup for the first time. Analysis done by Kaplan-Meier. Adverse events were graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version (V) 4.0. Medical doctor performed evaluation and grading of clinical and functional mucositis for the measured site weekly during the radiation treatment course and biweekly after completion of radiation until oral mucositis was \< grade 2. A pain medication assessment was done for each mucositis time point. Patients completed the Oral Mucositis Weekly Questionnaire-Head and Neck cancer (OMWQ-HN) during and after treatment until oral mucositis is \< grade 2.
Duration of Grade 2 or Higher Oral Mucositis After First Oral Mucositis Was Observed.
时间窗: 3 years
The duration of grade 2 or higher oral mucositis was measured as the time from the first time oral mucositis was observed by a clinician at the weekly checkup until the oral mucositis was resolved. The data was analyzed in a mixed effects model to account for the within subject correlation, since each patient contributed two measurements to the data set. The model was limited to those subjects who had experienced mucositis and then the outcome was the duration of grade 2 or higher mucositis. This allowed us to model the data in a mixed effects model with the continuous outcome of duration of grade 2 or higher mucositis.
次要结局
- Relationship Between the Measured Lateral Tongue Mucosal Dose and the Amount of Narcotic Use(3 years)
- How Does Increase in Soreness Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose(3 years)
- How Does Increase in Pain Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose?(3 years)
研究者
Quynh-Thu Le
Professor of Radiation Oncology
Stanford University