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.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 7
- 主要终点
- Skin toxicities
研究概览
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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 (Drug)
patient with epidermoid cancer
receiving Cetuximab and radiotherapy
干预措施: Radiotherapy (Radiation)
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)
研究者
研究点 (7)
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