A Phase III Study to Evaluate the Impact of Maintaining Haemoglobin Levels Above 120g/L Verses Above 100g/L in Anaemic Patients With Carcinoma of the Cervix Receiving Concurrent Cisplatin and Radiation Therapy

Tri-Service General Hospital0 个研究点目标入组 2 人开始时间: 2008年4月最近更新: 2009年6月19日

适应症

试验速览

阶段: 3 期
状态: 暂停
发起方: Tri-Service General Hospital
入组人数: 2
主要终点: The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the feasibility, safety and short term effects on health related quality of life, of maintaining hemoglobin from 120 to 130 g/L versus from 100 to 110 g/L, with red cell concentrate (RCC) transfusion, in women having chemo-radiation for cancer of the cervix.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Supportive Care
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Previously untreated cervix cancer
•FIGO stage IB2, II, IIIB, IVA
•Suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation

排除标准

•Hemoglobin level above 125g/L
•Lower one-third vaginal involvement
•Para-aortic lymphadenopathy

结局指标

主要结局

The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L

时间窗: 5 years

次要结局

未报告次要终点

研究者

发起方

Tri-Service General Hospital

申办方类型

Other

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