NCT00517621已完成2 期
A Multicenter Prospective Phase II Study Evaluating Peripheral Neurotoxicity by Using FACT-GOG/NTX Questionnaire in Patients With Ovarian Cancer in Relapse Treated by Paclitaxel +/- EPO. Validation of a French Version of This Questionnaire
ARCAGY/ GINECO GROUP1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2006年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Validation of a french version of FACT-GOG/NTX of peripheral neurotoxicity questionnaire
研究概览
简要总结
validation of a french version of FACT-GOG/NTX and using this questionnaire to evaluate the incidence of the peripheral neurotoxicity in patients treated for ovarian cancer with paclitaxel associated or not with EPO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Femal patient aged > 18 years
- •Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneal
- •patients whose disease progresses or relapses
- •patients having received at least a line of platinum-based chemotherapy
- •patients whose treatment of relapse is envisaged to comprise paclitaxel
- •patients who will receive EPO for treatment of their anaemia
- •ECOG performans status < 2
- •life expectancy > 16 weeks
- •patient who has clearly given her consent by signing on informed consent form prior to participation
排除标准
- •peripheral neuropathy grade > 2
- •history of ischemic cardiopathy, congestive heart failure (NYHA>2), arrhythmia, hypertension or significant valvulopathy
- •abnormal biological values
- •A therapy or a serious disease which could involve a risk for the patient or interfere with the aims of the study
- •patient who is pregnant, breast feeding or using inadequate contraception
- •concomitant therapy by a potentially neurotoxic drug
- •concomitant inclusion in another therapeutic trial which could interfere with the aims of the study
- •patient who for familial, sociological, geographical or psychological condition could not be followed correctly
结局指标
主要结局
Validation of a french version of FACT-GOG/NTX of peripheral neurotoxicity questionnaire
次要结局
- - incidence and severity of the peripheral neurotoxicity according to whether the patients are treated or not by EPO
- - variation of the rate of haemoglobin during chemotherapy
- - Incidence of the thrombo-embolic events according to whether the patients are treated or not by EPO
研究者
研究点 (1)
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