Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 310
- 试验地点
- 7
- 主要终点
- loco-regional control
研究概览
简要总结
There is no consensus on the indication of postoperative radiotherapy for early stages oral and oropharyngeal squamous cell carcinoma with complete pathological resection and no neck node metastasis, but most of the institutions do not give any post-operative treatment. Loco-regional control rates range between 80-85% at five years. Surgical margins molecular analysis for microsatellite instability (MSI) marker could help to select the high-risk patients who should receive postoperative radiotherapy. We expect to include 120 patients in five years and have 60 informative tumors for MSI marker. Patients with positive molecular margins will receive postoperative radiotherapy (50 Gy). Patients with negative molecular margins will not receive radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Oral and oropharynx (exclusion vallecula) squamous cell carcinoma
- •unique, untreated tumor
- •N0 or nodes <3cm
- •complete pathological resection
- •no perineural spread, vascular emboli <5
- •pN0 or <=2N+R-
- •signed inform consent
排除标准
- •Vallecula carcinoma
结局指标
主要结局
loco-regional control
时间窗: 5 years
次要结局
未报告次要终点
