Feasibility Study of Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma: Means of Toxicity Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Feasibility of TFRT Planning and Delivery Defined by Number of Participants Starting Radiotherapy Within 15 Days of Simulation
研究概览
简要总结
This study will evaluate the feasibility of using more advanced IMRT (intensity modulated radiation therapy) techniques. This new technique is termed Temporally Feathered Radiation Therapy (TFRT). TFRT is designed to reduce the side effects of conventional radiation therapy. Research has shown that TFRT may lessen these side effects.
详细描述
The primary objective of this study is to determine the feasibility of TFRT planning and delivery for head and neck squamous cell carcinoma. Secondary objectives include estimating grade 3-5 acute toxicity (within 90 days) and describing patient-reported outcomes (PRO) of toxicity during and after TFRT. This study is planned as a single arm feasibility trial to demonstrate clinical delivery of TFRT plans. Five patients will be accrued as a single cohort.
When using standard-of-care intensity modulated radiation therapy (IMRT), a single radiation plan is created and delivered on a daily basis Monday-Friday for a total of 7 weeks. In contrast, when using TFRT, up to 5 different plans are created and delivered each specific day of the week. Treatments will still occur on a daily basis Monday-Friday for 7 weeks. In each of these radiation plans used for TFRT, the radiation dose that will be delivered to the nearby healthy tissues will vary, allowing for increased time for normal tissue to recover from radiation-induced damage. Once weekly, a slightly higher radiation dose will be delivered to the "feathered" organ. On the remaining four days of the week, a slightly lower radiation dose will be delivered to the "feathered" organ. The radiation dose that will be delivered to the areas of cancer will not be changed. In this study, only the radiation dose delivered to the normal healthy tissues will be changed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Subjects must have histologically or cytologically confirmed squamous cell carcinoma arising from a primary head and neck site (oral cavity, oropharynx, larynx/hypopharynx, nasopharynx).TX-4, NX-3, MX-0 stages are permitted.
- •Subjects must be eligible for definitive radiation therapy (70Gy in 35 fractions) with or without chemotherapy.
- •Karnofsky Performance status ≥
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Subjects receiving any other investigational agents.
- •Postoperative radiotherapy is not permitted.
- •History of prior head and neck radiation therapy.
- •Subjects with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant or breastfeeding women are excluded from this study because radiation therapy has the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with radiation therapy, breastfeeding should be discontinued if the mother is treated with radiation therapy. These potential risks may also apply to other agents used in this study.
- •The patient cannot have distant metastatic disease (or M1 disease by AJCC 8th edition).
结局指标
主要结局
Feasibility of TFRT Planning and Delivery Defined by Number of Participants Starting Radiotherapy Within 15 Days of Simulation
时间窗: 15 days from start of treatment
Number of participants starting radiotherapy within 15 days of simulation. The TFRT technique will be deemed feasible if 3/5 participants meet this criteria.
次要结局
- Number of Participants Who Experienced Grade 3-5 Acute Toxicities Per CTCAE Version 4(Up to 90 days after treatment)
- Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-C30 Questionnaire(At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment)
- Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-H&N35 Questionnaire(At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment)
- Number of Participants Considered Compliant With Plan Delivery(5 months from start of treatment)
- Participant-reported Outcomes (PRO) of Mouth Dryness After TFRT Using Xerostomia Questionnaire(At week 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment)