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.
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.
研究者
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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