Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 6
- 主要终点
- Number of Participants With Local Control
研究概览
简要总结
This study will evaluate whether a reduction in the radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity.
Hypothesis- The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy while maintaining high rates of local control in patients who had a negative PET scan following rituximab-containing chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic documentation of diffuse large B-cell lymphoma, or any of its variants as defined in the WHO classification
- •Completion of at least 4 cycles of a rituximab-containing, anthracycline-based combination chemotherapy
- •Negative post-chemotherapy (or interim) PET scan
- •Absolute neutrophil count greater than 1500 and platelet count greater than 40,000
- •Negative pregnancy test in women of child-bearing potential
- •For patients with HIV/AIDS, the following must be true:
- •The patient is compliant on combination anti-retroviral therapy (CART)
- •The patient has CD4 count ≥ 200 at time of diagnosis
排除标准
- •Any contraindications to irradiation
- •Primary CNS lymphoma
结局指标
主要结局
Number of Participants With Local Control
时间窗: 5 years
This trial will accrue 62 patients over a time period of approximately 5-6 years. The primary objective is to determine whether the number of participants with local control at 5 years, estimated from the Kaplan-Meier curve of time-to-local failure, is as high as that observed in historical controls, i.e., 0.90.
次要结局
- Percentage of Participants With Progression-free Survival at 5 Years(5 years)
- Percentage of Participants With Overall Survival(5 years)
- Number of Participants With Local, Distant, or Local+Distant Failure(5 years)