NCT01228565已完成3 期
Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
Groupe Oncologie Radiotherapie Tete et Cou5 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2010年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 5
- 主要终点
- Radio-dermatitis grade 2, 3, 4 (NCI-CTC V3)
研究概览
简要总结
The aim of this randomized trial is to compare the rate of radio-dermatitis grade 2+ (NCI-CTC V3.0) in patients receiving radiotherapy+Erbitux+placebo versus in patients receiving radiotherapy+Erbitux+OTD70DERM® for the treatment of head and neck carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux
排除标准
- •IMRT; Concomitant chemotherapy
研究组 & 干预措施
Placebo
Placebo Comparator
Radiotherapy+Erbitux+Placebo
干预措施: Radiotherapy + Erbitux® + placebo (Other)
OTD70DERM
Experimental
Radiotherapy+Erbitux+OTD70DERM®
干预措施: Radiotherapy+Erbitux+OTD70DERM (Other)
结局指标
主要结局
Radio-dermatitis grade 2, 3, 4 (NCI-CTC V3)
时间窗: 3 months
Radio-dermatitis grade 2, 3, 4 (according to the NCI-CTC V3. Radio-dermatitis will be evaluated twice a week during radiotherapy and at M1, M2 and M3 after end of treatment.
次要结局
- Quality of life(3 months)
研究者
研究点 (5)
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