NCT00210314已完成2 期
Randomized Phase II Trial on Primary Chemotherapy With High-dose Methotrexate, Alone or Associated With High-dose Cytarabine, Followed by Response- and Age-tailored Radiotherapy for Immunocompetent Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
International Extranodal Lymphoma Study Group (IELSG)1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2003年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- The main endpoint is the complete remission (CR) rate after chemotherapy
研究概览
简要总结
Aim of the study is to establish in a prospective, randomized clinical trial the activity of primary chemotherapy containing high dose-methotrexate, alone or combined with high dose cytarabine, in patients with primary central nervous system lymphoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of non-Hodgkin's lymphoma.
- •Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
- •Disease exclusively localized into the central nervous system, cranial nerves or eyes.
- •Untreated patients (patients treated with steroids alone are eligible).
- •At least one measurable lesion.
- •Age 18 - 75 years.
- •ECOG performance status < 3
- •HBsAg-negative and Ab anti-HCV-negative serologic status.
- •No known HIV disease or immunodeficiency.
- •Adequate bone marrow (PLT > 100000 mm3, Hb ≥ 9 g/dl, ANC ≥ 2.000 mm3), renal (creatinine clearance ≥ 60 mL/min), cardiac (VEF ≥ 50%), and hepatic function (total serum bilirubin < 3 mg/dL, AST/ALT and gGT < 2 per upper normal limit value).
- •No previous or concurrent malignancies with the exception of surgically cured cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer and of other cancers without evidence of disease since at least 5 years (patients with a previous lymphoma diagnosis will be excluded).
- •Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
- •No concurrent treatment with other experimental drugs.
- •Informed consent signed by the patient before registration
排除标准
- 未提供
研究组 & 干预措施
High-dose methotrexate alone
Active Comparator
干预措施: high dose methotrexate (Drug)
High-dose methotrexate alone
Active Comparator
干预措施: radiotherapy (Radiation)
High-dose methotrexate associated with high dose cytarabine
Experimental
干预措施: high dose methotrexate (Drug)
High-dose methotrexate associated with high dose cytarabine
Experimental
干预措施: high dose cytarabine (Drug)
High-dose methotrexate associated with high dose cytarabine
Experimental
干预措施: radiotherapy (Radiation)
结局指标
主要结局
The main endpoint is the complete remission (CR) rate after chemotherapy
次要结局
- Event-free survival
- Early and late neurotoxicity
- Overall response rate
- Response duration (time to relapse or progression) for responder patients
- Overall survival
- Meningeal relapse rate
研究者
研究点 (1)
Loading locations...
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