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临床试验/NCT00232960
NCT00232960Unknown不适用

Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study

Gustave Roussy, Cancer Campus, Grand Paris7 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2005年10月1日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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