NCT00079261已完成2 期
Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma
European Organisation for Research and Treatment of Cancer - EORTC11 个研究点 分布在 5 个国家目标入组 25 人开始时间: 2004年1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
- 入组人数
- 25
- 试验地点
- 11
- 主要终点
- Complete response as assessed by Cheson criteria
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together with gemcitabine to see how well it works compared to giving combination chemotherapy alone in treating patients with previously untreated aggressive stage II, stage III, or stage IV non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Compare the complete response rate (confirmed or unconfirmed) in patients with previously untreated aggressive non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone with vs without gemcitabine.
Secondary
- Compare the safety profile of these regimens in these patients.
- Compare the feasibility of these regimens, defined as the proportion of courses given as scheduled, in these patients.
- Compare freedom from treatment failure in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of 1 of the following WHO subtypes:
- •Diffuse large B large cell lymphoma (including all clinical and morphologic variants)
- •Grade 3 follicular lymphoma
- •Extranodal T/NK cell lymphoma, nasal type
- •Enteropathy-type T cell lymphoma
- •Hepato-splenic T cell lymphoma
- •Peripheral T cell lymphoma, unspecified
- •Angioimmunoblastic lymphoma
- •Anaplastic large cell lymphoma, systemic type
- •Stage II-IV disease
- •At least 1 site of measurable disease (e.g., lymph node or lymph node mass)
- •The following subtypes are not allowed:
- •Mantle cell lymphoma
- •Burkitt's lymphoma
- •Precursor B or T cell lymphoma
- •Primary cutaneous B or T cell lymphoma
- •No CNS involvement by lymphoma
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC > 3,000/mm^3
- •Neutrophil count > 1,000/mm^3
- •Platelet count > 100,000/mm^3
- •Bilirubin < 2.5 times normal (unless due to lymphoma)
- •ALT and AST < 2.5 times normal (unless due to lymphoma)
- •Creatinine < 2.0 mg/dL
- •Cardiovascular
- •No severe cardiac disease that would preclude study participation or limit life expectancy
- •FEV_1 and DLCO ≥ 75% of predicted (unless due to lymphoma)
- •No severe pulmonary disease that would preclude study participation or limit life expectancy
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- •No severe neurologic or metabolic disease that would preclude study participation or limit life expectancy
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent monoclonal antibodies
- •Chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy
- •No concurrent radiotherapy
- 另有 5 项未显示
排除标准
- 未提供
结局指标
主要结局
Complete response as assessed by Cheson criteria
次要结局
- Toxicity as assessed by CTC 2.0
- Proportion of courses given as scheduled
- Freedom from treatment failure as assessed by Cheson criteria
研究者
研究点 (11)
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