A Phase II Study of Radiotherapy Followed by Chemotherapy With DICEP Regimen in Patients With NK/T-cell Lymphoma
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 3-year Progression-free survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.
详细描述
For patients with stage I/II NK/T-cell lymphoma, the sequence of radiotherapy and chemotherapy is controversial. Some studies demonstrated the advantage of upfront radiotherapy. Therefore, we designed this single-arm phase II study to evaluate the efficacy and safety of radiotherapy followed by adjuvant chemotherapy with DICE regimen plus peg-asparaginase which was proved to be effective in NK/T-cell lymphoma.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 14-70 years old
- •Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract
- •ECOG performance status 0-1
- •Life expectancy of more than 3 months
- •Without prior history of pancreatitis
- •Adequate bone marrow and organ functions
排除标准
- •Low risk population (Definition: stage I without local invasion, B symptoms and high LDH level)
- •Pregnant or lactating women
- •With contraindication of steroid including uncontrolled diabetes
- •Serious uncontrolled diseases and intercurrent infection
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
研究组 & 干预措施
Radiotherapy followed by chemotherapy
Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1
干预措施: Radiotherapy followed by chemotherapy (Drug)
结局指标
主要结局
3-year Progression-free survival
时间窗: 3 years
次要结局
- Overall response rate(3 years)
- 3-year overall survival(3 years)
- Safety(3 years)
研究者
Ye Guo
Assocaite Director of Medical Oncology Department
Fudan University