HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET
试验速览
- 阶段
- 3 期
- 入组人数
- 1,150
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS).
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
- •Hodgkin Lymphoma
- •CS I, II without risk factors
- •large mediastinal mass (> 1/3 of maximum transverse thorax diameter)
- •extranodal involvement
- •elevated ESR
- •3 or more involved nodal areas
- •Written informed consent
排除标准
- •Leucocytes < 3000/µl
- •Platelets < 100000/µl
- •Hodgkin Lymphoma as composite lymphoma
- •Activity index (WHO) > 2
研究组 & 干预措施
A
2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy
干预措施: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine) (Drug)
A
2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy
干预措施: 20 Gy IFRT (Involved Field Radiotherapy) (Radiation)
B
2 cycles ABVD followed by 20 Gy IF-RT if FDG-PET is positive after chemotherapy; 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy
干预措施: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine) (Drug)
B
2 cycles ABVD followed by 20 Gy IF-RT if FDG-PET is positive after chemotherapy; 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy
干预措施: 20 Gy IFRT (Involved Field Radiotherapy) (Radiation)
结局指标
主要结局
Progression Free Survival
时间窗: 5 years
次要结局
- acute toxicity(5 years)
- late toxicity(5 years)
- CR rate(5 years)
- overall survival(5 years)
研究者
Prof. Dr. Andreas Engert
Prof.
University of Cologne