NCT00005867已完成3 期
Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkin's Lymphoma
Lymphoma Trials Office92 个研究点 分布在 1 个国家目标入组 310 人开始时间: 1998年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 92
- 主要终点
- Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two regimens of combination chemotherapy and comparing how well they work in treating patients with aggressive non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Compare the overall survival, failure free survival, disease specific survival, relapse free survival, and response rate in patients with aggressive non-Hodgkin's lymphoma treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP).
- Compare the early and late toxicities of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1 and vincristine and bleomycin IV on day 8. Treatment continues every 14 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral prednisolone daily on courses 1 and 2 and every other day beginning on course 3 and continuing until the end of treatment.
- Arm II: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, then every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven previously untreated bulky stage IA or stage IB-IV aggressive non-Hodgkin's lymphoma of 1 of the following types:
- •Working formulation:
- •Follicular large cell
- •Diffuse mixed cell
- •Diffuse large cell
- •Diffuse immunoblastic OR
- •REAL classification:
- •Diffuse large B-cell
- •Peripheral T-cell
- •Measurable or evaluable disease
- •Good prognosis defined as no more than one of the following:
- •Stage III/IV disease
- •LDH greater than upper limit of normal
- •ECOG/WHO 2-4
- •No lymphoblastic or Burkitt's lymphoma
- •No CNS involvement
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •See Disease Characteristics
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Hemoglobin at least 10 g/dL
- •Neutrophil count at least 2,000/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin, AST, and ALT no greater than 1.5 times upper limit of normal
- •Creatinine no greater than 1.7 mg/dL
- •Cardiovascular:
- •Ejection fraction at least 50% unless dysfunction attributable to lymphoma
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other concurrent serious uncontrolled medical conditions
- •No other prior malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy to more than 35% of hematopoietic sites
- •Concurrent consolidation radiotherapy allowed
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP)
次要结局
- Failure-free survival, disease specific survival, relapse-free survival, death due to toxicity, response rate, and toxicity at 4 years
研究者
研究点 (92)
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