NCT03217188已完成2 期
A Phase II Study of Proton Re-Irradiation for Recurrent Head and Neck Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 9
- 主要终点
- locoregional recurrence-free
研究概览
简要总结
The purpose of this study is to evaluate the tumor control and the side effects of using proton therapy for head and neck cancer that has come back.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patient willing and able to provide written informed consent
- •Age ≥18 years at the time of consent
- •Pathologically confirmed diagnosis of a recurrent or a new primary head and neck cancer
- •A history of prior radiation to the head and neck (>/= 40 Gy, in 2 Gy/fraction equivalent)
- •The recurrent or the second primary tumor is unresectable, the patient elects against surgical resection; patients who underwent surgery who has indications for postoperative radiation therapy is also eligible
- •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 Note: Patient with <6 months of life expectancy will be treated with palliative QUAD shot radiotherapy and those with > 6 months of life expectancy will be treated with conventionally fractionated full dose re-irradiation approach. Additional other factors determining which patients will be treated with Quad Shot therapy rather than full dose are if the patients have poor performance status, bulky or diffuse disease, significant medical co-morbidities, and significant metastatic disease burden.
排除标准
- •Women who are pregnant or lactating
- •Inability to comply with study and/or follow-up procedures
- •<6 months between completion of prior RT and initiation of reirradiation using proton therapy
结局指标
主要结局
locoregional recurrence-free
时间窗: 12 months
Locoregional recurrence includes events of local and/or regional recurrence, or death due to any cause. Patients who are lost to follow-up without any event may be removed from the protocol at the discretion of the principal investigator.
次要结局
未报告次要终点
研究者
研究点 (9)
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