A Randomized Phase II Study of Comparing Radiotherapy Alone With Concurrent Chemoradiation in Patients With Low Risk NK/T-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 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 prove the superiority of concurrent chemoradiation compared with radiotherapy alone in patients with low risk NK/T-cell lymphoma.
详细描述
Radiotherapy alone is commonly used in NK/T-cell lymphoma without adverse risk including lymph node involvement, local invasion, B symptoms and high LDH level. Recently, methotrexate was prove to be a radiosensitizer in NK/T-cell lymphoma cells. Therefore, the investigators aim to verify the superiority and safety of weekly methotrexate in combination with radiotherapy in a randomized phase II study.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 18-75 years old
- •Histological confirmed, previously untreated stage IE nasal NK/T cell lymphoma without following risk factors including local invasion, B symptoms and high LDH level
- •ECOG performance status 0-1
- •Life expectancy of more than 3 months
- •Adequate bone marrow and organ functions
排除标准
- •non-nasal NK/T-cell lymphoma
- •Prior exposure of methotrexate
- •With third space effusion
- •Pregnant or lactating women
- •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 alone
Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy
干预措施: Radiotherapy alone (Radiation)
Concurrent chemoradiation
Concurrent chemoradiation
Chemotherapy:
Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy
干预措施: Radiotherapy alone (Radiation)
Concurrent chemoradiation
Concurrent chemoradiation
Chemotherapy:
Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy
干预措施: Concurrent chemoradiation (Drug)
结局指标
主要结局
3-year Progression-free survival
时间窗: 3 years
次要结局
- 3-year overall survival(3 years)
- Overall response rate(3 years)
研究者
Ye Guo
Assocaite Director of Medical Oncology Department
Fudan University