The H10 EORTC/GELA/IIL Randomized Intergroup Trial on Early FDG-PET Scan Guided Treatment Adaptation Versus Standard Combined Modality Treatment in Patients With Supradiaphragmatic Stage I/II Hodgkin's Lymphoma
试验速览
- 阶段
- 3 期
- 入组人数
- 1,952
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET scan), may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET scan-guided therapy is more effective than standard therapy in treating Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying FDG-PET scan-guided therapy to see how well it works compared with standard therapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Evaluate whether chemotherapy alone is as effective, but less toxic, as combined modality treatment, in terms of progression-free survival (PFS), in patients with favorable or unfavorable supradiaphragmatic stage I or II Hodgkin's lymphoma who are fludeoxglucose F 18 positron emission tomography (FDG-PET) scan negative after two courses of doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD).
Secondary
- Evaluate whether early change of chemotherapy from ABVD to escalated cyclophosphamide, doxorubicin hydrochloride, vincristine, bleomycin, etoposide, procarbazine hydrochloride, and prednisone (escalated BEACOPP) improves the PFS of patients who are FDG-PET scan positive after two courses of ABVD.
- Confirm that early response by FDG-PET scan is predictive of the outcome of patients randomized to the standard treatment arm.
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
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Favorable - Standard - any PET outcome
ABVDx3 cycles + Involved node RT (IN-RT) 30 Gy (+boost of 6Gy to residual lesions); FDG-PET after two cycles of ABVD for comparison with the experimental arm will be performed but no treatment adaptation will take place.
干预措施: ABVD q4 weeks (Drug)
Favorable - Standard - any PET outcome
ABVDx3 cycles + Involved node RT (IN-RT) 30 Gy (+boost of 6Gy to residual lesions); FDG-PET after two cycles of ABVD for comparison with the experimental arm will be performed but no treatment adaptation will take place.
干预措施: IN-RT 30 Gy (+ boost 6 Gy residual) (Radiation)
Favorable - Standard - any PET outcome
ABVDx3 cycles + Involved node RT (IN-RT) 30 Gy (+boost of 6Gy to residual lesions); FDG-PET after two cycles of ABVD for comparison with the experimental arm will be performed but no treatment adaptation will take place.
干预措施: FDG-PET scan (Procedure)
Favorable - Experimental - PET negative
ABVDx2 cycles; then FDG-PET evaluation:
PET negative: ABVDx2 without further RT (total of 4 cycles!)
干预措施: ABVD q4 weeks (Drug)
Favorable - Experimental - PET negative
ABVDx2 cycles; then FDG-PET evaluation:
PET negative: ABVDx2 without further RT (total of 4 cycles!)
干预措施: FDG-PET scan (Procedure)
Favorable - Experimental - PET positive
ABVDx2 cycles; then FDG-PET evaluation:
PET positive: presumed poor-risk: switch to escalated BEACOPPx2 + INRT30Gy (+boost 6Gy to residual lesions).
干预措施: BEACOPP escalated q3 weeks (Drug)
Favorable - Experimental - PET positive
ABVDx2 cycles; then FDG-PET evaluation:
PET positive: presumed poor-risk: switch to escalated BEACOPPx2 + INRT30Gy (+boost 6Gy to residual lesions).
干预措施: IN-RT 30 Gy (+ boost 6 Gy residual) (Radiation)
Favorable - Experimental - PET positive
ABVDx2 cycles; then FDG-PET evaluation:
PET positive: presumed poor-risk: switch to escalated BEACOPPx2 + INRT30Gy (+boost 6Gy to residual lesions).
干预措施: FDG-PET scan (Procedure)
Unfavorable - Standard - Any PET outcome
ABVDx4 cycles + IN-RT 30Gy (+boost 6Gy to residual lesions). FDG-PET after two cycles of ABVD for comparison with the experimental arm will be performed but no treatment adaptation will take place.
干预措施: ABVD q4 weeks (Drug)
Unfavorable - Standard - Any PET outcome
ABVDx4 cycles + IN-RT 30Gy (+boost 6Gy to residual lesions). FDG-PET after two cycles of ABVD for comparison with the experimental arm will be performed but no treatment adaptation will take place.
干预措施: IN-RT 30 Gy (+ boost 6 Gy residual) (Radiation)
Unfavorable - Standard - Any PET outcome
ABVDx4 cycles + IN-RT 30Gy (+boost 6Gy to residual lesions). FDG-PET after two cycles of ABVD for comparison with the experimental arm will be performed but no treatment adaptation will take place.
干预措施: FDG-PET scan (Procedure)
Unfavorable - Experimental - PET negative
ABVDx2 cycles; then FDG-PET evaluation:
PET negative: ABVDx 4 cycles, without RT (total of 6 cycles)
干预措施: ABVD q4 weeks (Drug)
Unfavorable - Experimental - PET negative
ABVDx2 cycles; then FDG-PET evaluation:
PET negative: ABVDx 4 cycles, without RT (total of 6 cycles)
干预措施: FDG-PET scan (Procedure)
Unfavorable - Experimental - PET positive
ABVDx2 cycles; then FDG-PET evaluation:
PET positive: presumed poor-risk: switch to escalated BEACOPPx2 + INRT 30Gy (+boost 6Gy to residual lesions).
干预措施: BEACOPP escalated q3 weeks (Drug)
Unfavorable - Experimental - PET positive
ABVDx2 cycles; then FDG-PET evaluation:
PET positive: presumed poor-risk: switch to escalated BEACOPPx2 + INRT 30Gy (+boost 6Gy to residual lesions).
干预措施: IN-RT 30 Gy (+ boost 6 Gy residual) (Radiation)
Unfavorable - Experimental - PET positive
ABVDx2 cycles; then FDG-PET evaluation:
PET positive: presumed poor-risk: switch to escalated BEACOPPx2 + INRT 30Gy (+boost 6Gy to residual lesions).
干预措施: FDG-PET scan (Procedure)
结局指标
主要结局
Progression-free survival
次要结局
- Event-free survival
- Overall survival
- Long-term toxicity, in terms of secondary malignancies, cardiovascular events, and pulmonary events