First International Inter-Group Study for Classical Hodgkin's Lymphoma in Children and Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,134
- 试验地点
- 2
- 主要终点
- Event-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. It is not yet known which combination chemotherapy regimen is more effective in treating Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine whether the 5-year event-free survival (EFS) rate in pediatric patients with Hodgkin's lymphoma with an adequate response after 2 courses of vincristine, etoposide, prednisone, and doxorubicin hydrochloride (OEPA) (without radiotherapy) are consistent with an estimated target EFS rate of 90%.
- Compare the EFS (without a deterioration) of patients treated with procarbazine hydrochloride vs dacarbazine (treatment groups 2 and 3).
- Determine the treatment outcome of a standardized risk-adapted relapse strategy in these patients.
Secondary
- Determine whether the 5-year EFS rate in patients with Hodgkin's lymphoma with an inadequate response after 2 OEPA courses and standard involved-field radiotherapy are consistent with an estimated target EFS rate of 90%.
- Determine whether a positive positron emission tomography scan before planned high-dose chemotherapy with autologous stem cell transplantation has a negative prognostic significance.
- Compare the effect of dacarbazine vs procarbazine on the rate of infertility in males and premature menopause in females (treatment groups 2 and 3).
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
- — 至 17 Years（Child）
- 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
COPP
procarbazine-containing consolidation chemotherapy arm
干预措施: cyclophosphamide (Drug)
COPP
procarbazine-containing consolidation chemotherapy arm
干预措施: prednisolone (Drug)
COPP
procarbazine-containing consolidation chemotherapy arm
干预措施: prednisone (Drug)
COPP
procarbazine-containing consolidation chemotherapy arm
干预措施: procarbazine hydrochloride (Drug)
COPP
procarbazine-containing consolidation chemotherapy arm
干预措施: vincristine sulfate (Drug)
COPP
procarbazine-containing consolidation chemotherapy arm
干预措施: fludeoxyglucose F 18 (Radiation)
COPP
procarbazine-containing consolidation chemotherapy arm
干预措施: radiation therapy (Radiation)
COPDAC
procarbazine-free consolidation chemotherapy arm
干预措施: cyclophosphamide (Drug)
COPDAC
procarbazine-free consolidation chemotherapy arm
干预措施: dacarbazine (Drug)
COPDAC
procarbazine-free consolidation chemotherapy arm
干预措施: prednisolone (Drug)
COPDAC
procarbazine-free consolidation chemotherapy arm
干预措施: prednisone (Drug)
COPDAC
procarbazine-free consolidation chemotherapy arm
干预措施: vincristine sulfate (Drug)
COPDAC
procarbazine-free consolidation chemotherapy arm
干预措施: fludeoxyglucose F 18 (Radiation)
COPDAC
procarbazine-free consolidation chemotherapy arm
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Event-free survival
时间窗: 5 years
次要结局
- CTC (Common toxicity criteria) toxicity levels of therapy elements(5 years)
- Evidence of male infertility score(5 years)
- Evidence of female infertility score(5 years)
- Progression-free survival(5 years)
- Overall survival(5 years)
- Long-term consequences (e.g., premature menopause, secondary cancer)(5 years)
研究者
Christine Mauz-Körholz
Prof. Dr. med. Christine Mauz-Körholz
Martin-Luther-Universität Halle-Wittenberg