NCT02247232已完成3 期
Randomized, Double-blind, Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Patients With Locally Advanced Cervical Cancer - A Phase III Trial
Zeria Pharmaceutical3 个研究点 分布在 3 个国家目标入组 793 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 793
- 试验地点
- 3
- 主要终点
- Overall survival
研究概览
简要总结
This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical cancer on radiotherapy. The study will use a central randomization with a dynamic allocation using biased coin minimization.
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
- 21 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •FIGO stage (2008): IIIB, cervical cancer;
- •Pathologically confirmed squamous cell carcinoma of the cervix;
- •Patients with treatment-naive cervical cancer;
- •Patients without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node confirmed by CT scanning (Patients need not repeat CT scan at screening if CT data [film or electronic image] within 30 days before informed consent are available and can be provided for central imaging assessment);
- •Patients ≥21, ≤79 years of age at informed consent;
- •Patients for whom it is considered possible to carry out intracavitary radiation in radiotherapy;
- •Eastern Cooperative Oncology Group Performance Status: 0-2;
- •Patients with the following organ functions; (1) WBC ≥3,000/mm3; (2) Platelet count ≥100,000/mm3; (3) Hemoglobin ≥9.5 g/dL (correction by blood transfusion is allowed); (4) Total bilirubin ≤ three (3) times the upper limit of reference value at the clinical testing laboratory; (5) AST, ALT ≤ three (3) times the upper limit of reference value at the clinical testing laboratory; (6) Renal function:
- •If combination therapy with cisplatin is planned, creatinine clearance: ≥50 mL/min;
- •If combination therapy with cisplatin is not planned, creatinine ≤ twice (2) the upper limit of reference value at the clinical testing laboratory;
- •Patients who are willing to give informed consents. "
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Z-100
Experimental
干预措施: Z-100 (Drug)
结局指标
主要结局
Overall survival
时间窗: 5Years
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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