NCT00292695已完成2 期
A Phase II Study of Concurrent Chemoradiation for The Localized Nasal NK/T-cell Lymphoma
National Health Research Institutes, Taiwan1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2006年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- tumor response by CT scan or MRI
研究概览
简要总结
To determine whether adding combinational chemotherapy concurrently to conventional radiation will improve the response rate, event-free survival, and overall survival.
To test the dose intensity and toxicity of chemotherapy in concurrence with radiation.
To detect the blood EBV DNA level in Chinese Nasal NK/T-cell lymphoma patients and correlate to the treatment response and prognosis.
详细描述
Inclusion Criteria:
- Histologically proven extranodal NK/T-cell lymphoma, nasal type according to the WHO classification (must be pathology-proven EBV DNA positive as well as cytoplasmic CD3 +, while CD56+ is not an essential diagnostic criteria. ). Both newly diagnosed patients and who were previous chemotherapy-treated patients with residual or recurrent diseases will be allowed.
- Any of lymphomatous involvement exist in nasal cavity and/or paranasal sinuses, orbit, Waldeyer's ring, and oral cavity PS with ECOG scale 0-2.
- Stage I or contiguous stage II, measurable or evaluable lymphoma by clinical imaging No previous chemotherapy and/or radiotherapy.
- ANC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood.
- Age <70.
- Total bilirubin < 2.5 mg/dl Serum creatinine ≦1.5 mg/dl Blood urea nitrogen (BUN) ≦ 25 mg/dl
- Signed informed consent
Exclusion criteria:
- Pregnancy or lactation period
- Severe intercurrent illness, e.g. infection, heart failure
- Myocardial infarction within recent 12 months
- Known hypersensitivity to any component drug of the treatment regimen
TREATMENT PLAN
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven extranodal NK/T-cell lymphoma, nasal type according to the WHO classification (must be pathology-proven EBV DNA positive as well as cytoplasmic CD3 +, while CD56+ is not an essential diagnostic criteria. ). Newly diagnosed patients.
- •Any of lymphomatous involvement exist in nasal cavity and/or paranasal sinuses, orbit, Waldeyer's ring, and oral cavity performance status with ECOG scale 0-
- •Stage I or contiguous stage II, measurable or evaluable lymphoma by clinical imaging No previous chemotherapy and/or radiotherapy.
- •ANC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood.
- •Total bilirubin < 2.5 mg/dl, Serum creatinine ≦1.5 mg/dl, Blood urea nitrogen (BUN) ≦ 25 mg/dl
排除标准
- •1.Pregnancy or lactation period 2.Severe intercurrent illness, eg. Infection, heart failure 3.Myocardial infarction within recent 12 months 4.Known hypersensitivity to any component drug of the treatment regimen
结局指标
主要结局
tumor response by CT scan or MRI
时间窗: the first course of DVIP, one month after the last course of DVIP
次要结局
- EBV DNA level, AEs, Withdrawal from the study treatment(2-year overall survival and 5-year overall survival , event-free survival, toxicity.)
研究者
研究点 (1)
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