Elective Mucosal Irradiation in Head-and Neck Cancer of Unknown Primary, A Single Arm Phase II Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Mucosal recurrence free survival
研究概览
简要总结
The optimal treatment of HNCUP remains controversial and lacks evidence from prospective randomized trials. The management of these patients relies primarily on surgery and radiotherapy. The role of radiotherapy in sterilizing putative mucosal sites remains controversial. The main debate concerns the extent of the radiation field. Although pan-mucosal irradiation from the nasopharynx to the hypopharynx and bilateral neck nodes reduces the risk of emergence of a mucosal primary or a nodal relapse, it has been associated with significant toxicity and long-term morbidity (mostly xerostomia and dysphagia). Most single institution retrospective studies have not shown any advantage for more extensive irradiation.Therefore, elective mucosal irradiation may might be appropriate only for these patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Carcinomas metastatic to cervical lymph node with unknown primary
- •Squamous cell carcinoma, poorly differentiated carcinoma, or undifferentiated carcinoma
- •All patients must be suitable to attend regular follow-up and undergo toxicity assessment.
- •Stage T0, N1-3, M0 disease
- •Karnofsky score over 60
- •No significant cardiac, chest, gastrointestinal or renal morbidities
排除标准
- •Previous radiotherapy to the head and neck region
- •Previous malignancy except non-melanoma skin cancer
- •Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up
研究组 & 干预措施
EMI group
Elective mucosal irradiation
干预措施: Elective mucosal irradiaton (Radiation)
结局指标
主要结局
Mucosal recurrence free survival
时间窗: 3 years
from date of enrollment to date of first documented primary site emergence or death, assessed up to 3 years.
次要结局
- Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis)(2 months)
- Neck control rate(3 years)
- Disease-free survival(3 years)
- overall survival rate(3 years)
研究者
Guopei Zhu
M.D.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University