试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,370
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hodgkin´s lymphoma (histologically proven)
- •CS (PS) IA, IB, IIA,IIB without any of the following risk factors:
- •bulky mediastinal mass (> 1/3 maximum transverse thorax diameter)
- •extranodal involvement
- •ESR > 50 (A), > 30 (B-symptoms)
- •3 or more lymph node areas involved
- •written informaed consent
排除标准
- •Leukocytes <3000/microl
- •Platelets <100000/microl
- •Hodgkin´s Disease as "composite lymphoma"
- •Activity index (WHO) < grade 2
研究组 & 干预措施
Arm A
干预措施: Adriamycin (Drug)
Arm A
干预措施: Bleomycin (Drug)
Arm A
干预措施: Vinblastine (Drug)
Arm A
干预措施: DTIC (Drug)
Arm A
干预措施: 30 Gy IF-RT (Radiation)
Arm B
干预措施: Adriamycin (Drug)
Arm B
干预措施: Bleomycin (Drug)
Arm B
干预措施: Vinblastine (Drug)
Arm B
干预措施: DTIC (Drug)
Arm B
干预措施: 20 Gy IF-RT (Radiation)
Arm C
干预措施: Adriamycin (Drug)
Arm C
干预措施: Bleomycin (Drug)
Arm C
干预措施: Vinblastine (Drug)
Arm C
干预措施: DTIC (Drug)
Arm C
干预措施: 30 Gy IF-RT (Radiation)
Arm D
干预措施: Adriamycin (Drug)
Arm D
干预措施: Bleomycin (Drug)
Arm D
干预措施: Vinblastine (Drug)
Arm D
干预措施: DTIC (Drug)
Arm D
干预措施: 20 Gy IF-RT (Radiation)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 5 years
次要结局
未报告次要终点