NCT01487226Unknown2 期
A Phase II Trial of Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in FIGO Stage IA2-IIA Cervical Cancer
Korean Gynecologic Oncology Group2 个研究点 分布在 2 个国家目标入组 69 人开始时间: 2008年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Kaplan-Meier
研究概览
简要总结
Purpose Primary endpoint
- To evaluate the 3-year disease free survival Second endpoints
- To evaluate the 3-year & 5-year overall survival To analyze the toxicity and the quality of life
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •cervical cancer stage Ia2-IIa
- •histology; squamous, adeno, adenosquamous subtype
- •age; 20∼70 years
- •performance status; GOG 0∼2
- •no medical illness
- •hematologic, renal, hepatic function; normal
- •grossly no residual disease
- •histologically confirmed lymph nodes metastases
- •no parametrial extension and negative resection margin
- •number of retrieved lymph nodes; ≥ 20
排除标准
- •patients with grade 2 peripheral neuropathy
- •patients with uncontrolled infection
结局指标
主要结局
Kaplan-Meier
次要结局
- log-rank test Cox regression analysis
研究者
Taek Sang Lee
Principal Investigator
Korean Gynecologic Oncology Group
研究点 (2)
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