A Phase II Study of Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 6
- 主要终点
- Percentage of Participants With Local-regional Progression-free Survival
研究概览
简要总结
The purpose of this Phase 2 study is to find out what effect, good and/or bad, external beam radiation therapy, has on the patient and their thyroid cancer where surgery is not an option or where despite surgery, the disease is still present.
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
- •Pathologically confirmed diagnosis of non-anaplastic non-medullary thyroid cancer that is either grossly recurrent after surgery or unresectable with or without metastatic disease.
- •Age ≥18 years
- •Karnofsky performance status ≥70%
- •Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment.
- •Patients must have ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Women who are pregnant or lactating
- •Inability to comply with study and/or follow-up procedures
研究组 & 干预措施
IMRT and doxorubicin
All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered.
干预措施: Modified Barium Swallow Impairment Profile (MBSImP) (Other)
IMRT and doxorubicin
All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered.
干预措施: IMRT (Radiation)
IMRT and doxorubicin
All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered.
干预措施: DWI MRI (Device)
IMRT and doxorubicin
All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered.
干预措施: Doxorubicin (Drug)
结局指标
主要结局
Percentage of Participants With Local-regional Progression-free Survival
时间窗: 2 years
2-year cumulative incidence of locoregional progression/failure with death as a competing risk will be defined as infield progression if included in the RT field and meets one of the following criteria: 25% increase in tumor volume, new lesions, and/or 25% increase in metabolic tumor volume or total lesion glycolysis.
次要结局
- Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline(12 months)
- Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities(2 years)
- Rate of Late Dysphagia(2 years)
- Overall Survival(2 years)
- Rate of Late Xerostomia/Dry Mouth(2 years)