HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,100
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hodgkin Lymphoma
- •CS I, II with risk factor (stage IIB with risk factor 1 or 2 are not included)
- •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
Arm A
2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy
干预措施: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone) (Drug)
Arm A
2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy
干预措施: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine) (Drug)
Arm A
2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy
干预措施: 30Gy IF-RT (Involved-Field Radiotherapy) (Radiation)
Arm B
2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IN-RT if FDG-PET is positive after chemotherapy; 2 cycles BEACOPPescalated plus 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy
干预措施: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone) (Drug)
Arm B
2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IN-RT if FDG-PET is positive after chemotherapy; 2 cycles BEACOPPescalated plus 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy
干预措施: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine) (Drug)
Arm B
2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IN-RT if FDG-PET is positive after chemotherapy; 2 cycles BEACOPPescalated plus 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy
干预措施: 30Gy IN-RT (Involved-Node Radiotherapy) (Radiation)
结局指标
主要结局
Progression Free Survival
时间窗: 3 years
次要结局
- Overall Survival(3 years)
- CR rate(6 months)
研究者
Prof. Dr. Andreas Engert
Prof.
University of Cologne