NCT00133302终止3 期
Randomized Phase III Study of Standard CHOP (S-CHOP) Versus Biweekly CHOP (Bi-CHOP) in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this trial is to investigate the clinical benefit of the dose intensified regimen, Bi-CHOP in comparison to standard CHOP for advanced intermediate or high grade non-Hodgkin's lymphoma (NHL).
详细描述
The purpose of JCOG9809 was to determine whether treatment results of aggressive NHL could be improved by shortening intervals of CHOP chemotherapy with the prophylactic use of G-CSF. The primary endpoint was Progression Free Survival (PFS), and the planned accrual was 450. Until December, 2002, 323 patients with advanced aggressive NHL were randomized to standard CHOP arm (CHOP x 8, every three weeks) and biweekly CHOP arm (CHOP x 8, every two weeks).
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
- 15 Years 至 69 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intermediate- or high-grade non-Hodgkin's lymphoma, excluding cutaneous t-cell lymphoma (CTCL), adult T-cell leukemia-lymphoma (ATL) and T-cell lymphoblastic lymphoma (T-LbL) (Working Formulation)
- •Ann Arbor stage: II, III, IV
- •No prior chemotherapy or radiotherapy
- •Age: 15 to 69
- •Performance status (PS): 0, 1, 2
- •WBC >= 3,000 /mm3, ANC >= 1,200 /mm3, Platelet >= 75,000 /mm3
- •GOT/GPT <= 5 x Normal Upper Limit, T-Bil <= 2.0 mg/dL
- •Creatinine <= 2.0 mg/dL
- •Normal ECG, Ejection Fraction >= 50%
- •PaO2 >= 65 mmHg
- •Written informed consent
排除标准
- •Uncontrollable diabetes mellitus
- •Severe complication (infection, heart failure, renal failure, liver failure, etc)
- •Anamnesis of heart disease
- •Acute or chronic hepatitis, liver cirrhosis and portal hypertension
- •Synchronous or metachronous malignancy
- •Severe pulmonary dysfunction
- •Central nervous system (CNS) invasion
- •HIV positive
- •Hepatitis B surface antigen (HBs-Ag) positive
- •Hepatitis C virus antibody (HCV-Ab) positive
结局指标
主要结局
Progression free survival
次要结局
- Overall survival
- Complete remission rate
- Toxicity
研究者
研究点 (2)
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