A Prospective Non-randomised Trial of Chemotherapy and Radiotherapy for Osteolymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 20
- 主要终点
- Overall Survival. The time from registration to the date of death
研究概览
简要总结
This trial is intended to determine the results obtained when standard treatment for Non Hodgkin's lymphoma is applied to the disease in a rare subtype which arises in bone. Patients in the study undergo a detailed assessment, then treatment with chemotherapy and radiotherapy, followed by close monitoring.
详细描述
Patients with non-Hodgkin's lymphoma arising primarily in bone have been studied using a number of different names making literature searching difficult. The term Osteolymphoma has been proposed to make searching easier in the future. Patients in this study undergoing staging which includes isotope bone scanning and PET scanning where available. Eligible patients then undergo treatment with three cycles of CHOP chemotherapy at conventional doses and shrinking field radiotherapy to a total of 45 Gy. Monoclonal antibodies are not included as good results have been obtained without using them. After treatment the patients are regularly monitored. The trial is presented twice per year at the meetings of TROG, ALLG and AROLG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-Hodgkin's lymphoma in a bony site
- •Limited extraosseous disease
- •Ann Arbor stage IE
- •ECOG performance status <3
- •Expected survival > 6 months
- •Patients capable of childbearing are using adequate contraception.
- •Written informed consent
排除标准
- •Previous radiotherapy
- •Previous malignancy
- •Medically unfit to undergo treatment
研究组 & 干预措施
1
Chemotherapy followed by radiotherapy to begin 3 weeks after the last cycle.
干预措施: Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone. (Drug)
1
Chemotherapy followed by radiotherapy to begin 3 weeks after the last cycle.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Overall Survival. The time from registration to the date of death
时间窗: Main analysis when accrual is complete at approx. 10 years.
次要结局
- Time to local or regional failure. Measured from registration.(Main analysis when accrual is complete at approx. 10 years.)
- Pathological fracture rate. Measured from registration.(Main analysis when accrual is complete at approx. 10 years.)