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临床试验/NCT01647555
NCT01647555
已完成
不适用

Prospective Study About the Association of Radiotherapy and Cetuximab in the Treatment of Epidermoid Cancers, Locally Advanced, of the Head and Neck.

Centre Oscar Lambret7 个研究点 分布在 1 个国家目标入组 57 人2006年10月6日

概览

阶段
不适用
干预措施
Cetuximab
疾病 / 适应症
Epidermoid Head and Neck Cancer
发起方
Centre Oscar Lambret
入组人数
57
试验地点
7
主要终点
Skin toxicities
状态
已完成
最后更新
上个月

概览

简要总结

This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab.

详细描述

This prospective and multicentric study evaluates the skin toxicities in patients with locally Advanced head and neck epidermoid cancer, treated by Radiotherapy in association with Cetuximab.

注册库
clinicaltrials.gov
开始日期
2006年10月6日
结束日期
2014年10月1日
最后更新
上个月
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Age \> 18 years
  • Epidermoid head and neck carcinoma locally advanced
  • Indication of Cetuximab and radiotherapy
  • Karnofsky \>= 60
  • Patients participating to another compatible study could be included after consultation with the study director Patients could be beforehand treated for an other ORL cancer
  • The radiotherapy will be delivered for curative aim (minimal dose 66 Gy)

排除标准

  • other histology
  • Metastatic disease
  • Recurrent patients

研究组 & 干预措施

patient with epidermoid cancer

receiving Cetuximab and radiotherapy

干预措施: Cetuximab

patient with epidermoid cancer

receiving Cetuximab and radiotherapy

干预措施: Radiotherapy

结局指标

主要结局

Skin toxicities

时间窗: until week 38

according to NCI-CTCAE version 3.0

次要结局

  • Healthcare and evolution of skin toxicities(until week 38)
  • tumoral efficacy(6 months after treatment)
  • Quality of life reporting(baseline, week 4, month 6)

研究点 (7)

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