NCT01938105Unknown2 期
Preoperative Concurrent Chemoradiotherapy Combined With Nimotuzumab Injection for Locally Advanced Cervical Cancer: a Phase II Study
People's Hospital of Guangxi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Treatment related toxicities
研究概览
简要总结
The purpose of this study is to determine the feasibility and efficacy of preoperative nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable, locally advanced cervical cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven squamous cell cervical cancer
- •Stages IB2-IIIB according to FIGO Staging System
- •Age:18-75
- •Normal bone marrow function
- •Initial assessed and considered not candidates for operation
- •Signed study-specific consent form
排除标准
- •Pregnant or lactating women
- •Patients with other malignancies
- •Patients who received radiotherapy or chemotherapy previously
- •Presence of uncontrolled life-threatening illness
- •Allergy to platinum or monoclonal antibody
结局指标
主要结局
Treatment related toxicities
时间窗: at 1 year
Acute and chronic toxicities.
Tumor response after preoperative treatment
时间窗: assessed at 4-5 weeks after the completion of preoperative treatment
次要结局
- Overall survival(at 1 year)
- Progression-free survival(at 1 year)
研究者
Heming Lu
Associate Professor
People's Hospital of Guangxi
研究点 (1)
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