NCT00418535已完成2 期
A Phase II Study of Concurrent Chemoradiation Followed by VIPD (Etoposide/Ifosfamide/Cisplatin/Dexamethasone) in Stage I, II Nasal NK/T-cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
Nasal NK/T-cell lymphoma is a peculiar clinico-pathologic subtype of non-Hodgkin's lymphoma (NHL). Although most patients present with stage I/II, only 30-60% of the patients remain disease-free. The efficacy of the conventional anthracycline-based chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone [CHOPP]) has been unsatisfactory.
The optimal treatment of localized NK/T-cell lymphoma has not been defined yet. The optimal dose, sequence, and multi-modality treatment with involved field radiotherapy still need to be refined. This trial is to evaluate the efficacy of concurrent chemoradiotherapy with cisplatin followed by VIPD (etoposide, ifosfamide, cisplatin, dexamethasone) in localized NK/T-cell lymphoma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed NK/T-cell lymphoma
- •Localized (Ann Arbor stage I/II) disease
- •At least one measurable lesion
- •Age > 18
- •ECOG performance status 0 - 2
- •Expected life span of at least 12 weeks
- •Normal marrow function (hemoglobin ≥ 9.0 g/dL; absolute neutrophil count ≥ 1,500/mm3; platelet count ≥ 100,000/mm3)
- •Normal liver function (total bilirubin < 2x upper limit of normal [ULN], transaminase < 3x ULN)
- •Normal renal function (serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 50 mL/min)
- •Written informed consent
排除标准
- •Other malignancies except for treated non-melanoma skin cancers and cervical cancer in situ
- •Serious medical illnesses (congestive heart failure, angina, respiratory failure, and renal failure)
- •Acute or active infection requiring intravenous (IV) antibiotics
- •Pregnant, lactating women
- •Previous history of chemotherapy or radiotherapy
- •Concomitant medication that may influence the study drugs
- •Allergic reaction to study drugs
- •Grade 2 or greater peripheral neuropathy
研究者
研究点 (2)
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