A Phase II Trial of Intermediate Radiation Dose For Low Grade Follicular Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Complete response within the radiated volume at 1month post radiation
研究概览
简要总结
The purpose of this study is to determine the optimal radiation dose fractionation regimen for low grade follicular lymphoma.
It is hypothesized that the complete response rate with the use of 12 Gy in 6 daily fractions is 80% (10% total width of the confidence interval) at 3 months.
This phase II study will evaluate whether an intermediate dose for follicular lymphoma is associated with excellent response rates while minimizing acute and late toxicity.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years or older
- •Pathology review at Sunnybrook Health Sciences Centre showing low grade (grade 1- 2) follicular lymphoma
- •Previously un-irradiated stages I-IV low grade follicular lymphoma
- •Radiation indicated for local disease control (radical or palliative)
- •Able to give informed consent
- •Non-bulky targets (less than 7cm)
排除标准
- •Systemic therapy (including steroids) for lymphoma within 3 months before or after radiotherapy
- •Prognosis less than 3 months
- •Pregnancy
研究组 & 干预措施
12 Gy in 6 daily fractions
干预措施: 12 Gy in 6 daily fractions (Radiation)
结局指标
主要结局
Complete response within the radiated volume at 1month post radiation
时间窗: 1 month
Participants will be assessed for response at 1 month (primary outcome) and then 3 months following completion of radiotherapy, clinically or radiographically, as appropriate. Complete response is defined as absence of detectable disease in the radiated volume. Partial response is 50% or more reduction in the volume of disease in the radiated volume. Overall response is defined as complete and partial response. Stable disease is defined as no change in the irradiated tumour or less than 50% reduction. Progressive disease is defined as enlargement of the irradiated tumour
次要结局
- Overall survival, progression-free survival and toxicity(1 month and 3 month)