NCT01279772终止不适用
A Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas Treated With R-CHOP With or Without Radiotherapy
International Extranodal Lymphoma Study Group (IELSG)0 个研究点目标入组 1 人开始时间: 2011年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 主要终点
- local and CNS relapse rate
研究概览
简要总结
In this study, the investigators propose that the addition of rituximab will lower the risk of systemic and local relapses in patients with localized PBL. Patients will be treated with 6 cycles of RCHOP-14 or RCHOP-21. The administration of radiotherapy following chemotherapy is strongly recommended, based on the findings of the retrospective IELSG study, but will be at the discretion of the treating center.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated patients with DLBCL of the breast.
- •Patients must have CD20 positive tumors.
- •Stage IE or IIE.
- •Must have at least one objective measurable or evaluable disease. Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study.
- •Patients must have an ECOG performance status 0-
- •Patients must have adequate organ function as evidenced by the following laboratory studies ( within 2 weeks prior to registration):
- •Creatinine Clearance > 50 ml/min
- •Total bilirubin < 2.0 mg/dl and AST < 2 x upper limit of normal. If documented hepatic involvement with lymphoma, total bilirubin can be < 3 x ULN, and AST < 5 x ULN.
- •Absolute neutrophil count > 1500/mm3 and platelet count > 100,000/mm
- •If documented bone marrow involvement with lymphoma, absolute neutrophil count > 500/mm3 and platelet count > 50,000/mm
- •Patients must be age > 18 years.
- •Patients must have a normal left ventricular ejection fraction to be eligible.
排除标准
- •historical or radiographic evidence of CNS metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
- •pregnant or breast feeding patients. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.
- •active infection requiring parental antibiotics.
- •known HIV infection
结局指标
主要结局
local and CNS relapse rate
时间窗: 12-month
次要结局
- progression free survival(12-month)
- overall survival(5-year)
- overall, complete and partial response rates following RCHOP(at the end of chemotherapy)
研究者
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