NCT00210379已完成2 期
A Phase II Study of CHOP + Rituximab, With Intrathecal Methotrexate Followed by Radiotherapy in Patients With Primary Testicular Non-Hodgkin's Lymphoma
International Extranodal Lymphoma Study Group (IELSG)2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2000年11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
- 64
- 试验地点
- 2
- 主要终点
- Event-free survival
研究概览
简要总结
The primary objective assess the clinical activity of combination doxorubicin-containing chemotherapy plus monoclonal antibody anti-CD20 (Rituximab) plus intrathecal prophylactic chemotherapy and loco-regional radiotherapy in primary localised testicular DLCL and to assess the toxicity of this therapeutic strategy
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
- Male
- 接受健康志愿者
- 否
入选标准
- •age = 18 years.
- •ECOG performance status 0-2
- •Histologically proven primary testicular CD20-positive diffuse large B-cell non-Hodgkin's lymphoma, untreated
- •Ann Arbor stage IE or IIE. Bilateral testicular involvement at presentation will not be considered stage IV. In these patients the final Ann Arbor stage will be determined by the extent of nodal involvement.
- •Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible.
- •Adequate bone marrow reserve (ANC > 1.000/L, Plt > 100.000/L)
- •Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography
- •No previous therapy with monoclonal antibody anti-CD
- •No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
- •No other major life-threatening illnesses that may preclude chemotherapy
- •Have given written informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice
排除标准
- •impairment of renal function (creatinine > 2 mg/dl) or liver function (bilirubin > 2 mg/dl) unless due to lymphoma involvement
- •HIV positive patients
- •evolutive malignancy within 5 years with the exception of localized non-melanomatous skin cancer
结局指标
主要结局
Event-free survival
Progression-free survival
Disease-free survival
次要结局
- Overall survival will be a secondary end-point because post-relapse therapy is not specified in this protocol and is expected to be highly variable
研究者
研究点 (2)
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