The Efficacy and Safety of Etoposide, Dexamethasone, Peg-asparaginase or Plus Methotrexate With Sandwiched Radiotherapy in the Treatment of Stage I to II Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
试验速览
- 阶段
- 3 期
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%~10%. The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western countries, with poor prognosis. Radiotherapy plus chemotherapy has improved the survival for these patients. But the optimal treatment schedule is controversial. The previous protocols usually contained high dose methotrexate, but the application of them is limited for the toxicity.
详细描述
In mid-2016, we had the final evaluation of the phase 2 study of MESA with sandwiched radiotherapy in newly diagnosed early stage NKTCL (NCT02825147). We obtained the final overall response rate of MESA with sandwiched radiotherapy, while the 2-year progression free survival rate was not available at that timepoint. To make the study design of sample size more accurate, we changed the primary outcome endpoint from 2-year progression free survival rate to overall response rate. The change had been approved by the Ethics Committee in August 10, 2016. At that time, only fourteen patients were enrolled in NCT02631239.
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
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of extranodal NK/T cell lymphoma, nasal type, previously untreated
- •Age 14 ~ 70 years old
- •ECOG(Eastern Cooperative Oncology Group）performance status 0~2
- •Stage I to II
- •Life expectancy>6 months
- •Informed consented
排除标准
- •Chemotherapy before
- •Bone marrow transplantation before
- •History of malignancy
- •Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- •Other uncontrollable medical condition that may that may interfere the participation of the study
- •Lab at enrollment ALT or AST >3*ULN, AKP or bilirubin >2.5*ULN Creatinine>1.5*ULN
- •Not able to comply to the protocol for mental or other unknown reasons
- •Pregnant or lactation
- •HIV infection
研究组 & 干预措施
MESA
Methotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
干预措施: Methotrexate (Drug)
MESA
Methotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
干预措施: Etoposide (Drug)
MESA
Methotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
干预措施: Dexamethasone (Drug)
MESA
Methotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
干预措施: Pegaspargase (Drug)
MESA
Methotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
干预措施: Radiotherapy (Radiation)
ESA
Etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
干预措施: Etoposide (Drug)
ESA
Etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
干预措施: Dexamethasone (Drug)
ESA
Etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
干预措施: Pegaspargase (Drug)
ESA
Etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Overall response rate
时间窗: 21 days after 4 cycles of chemotherapy
次要结局
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Day 1 of each course and then every 3 months for 2 years)
- Overall survival(2-year)
- Progression free survival(2-year)