NCT01926821招募中1 期
The Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
The impact of sonifilan on the quality of life in patients with cervical cancer during radiation or chemoradiation therapy
- Primary endpoint : Quality of life
- Secondary endpoint : complications related to Sonifilan, treatment effect of Sonifilan
详细描述
Study design Prospective randomized controlled trial
Study period Protocol registration approval date - may/31/2016
Study drug Sonifilan(Sizofiran)
Study population
- Cervical cancer FIGO stage IA2-IVA patients will be participated.
- Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma
- age 20-75 year
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cervical cancer FIGO stage IA2 - IVA
- •Histologic type : SCC, Adenocarcinoma, Adenosquamous carcinoma
- •GOG performance status 0-2
排除标准
- •past radiation therapy history
- •Neuroendocrine carcinoma
- •concurrent other cancer
- •uncontrolled medical disease
- •ulcerative disease history
- •current pregnancy and lactation
研究组 & 干预措施
sonifilan
Experimental
Group who get sonifilan
干预措施: Sonifilan (Drug)
结局指标
主要结局
Quality of life
时间窗: 3 year
life quality assessment by filling out EORTC QOQ-C30, CX24, SF-36, FSFI pre-/on-/post-study
次要结局
- Complications of drug, treatment effects(3 year)
研究者
Jong-Hyeok Kim
Professor
Asan Medical Center
研究点 (1)
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