Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Response of bleeding to radiotherapy
研究概览
简要总结
The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls.
详细描述
The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls. (Tey et al.) With this dose fractionation is used for bleeding, there is an increase in response rates from 55%(historical) to 75%for pain, there is an increase in response rates from 25% (historical) to 45% for obstruction, there is an increase in response rates from 25% (historical) to 45%
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven adenocarcinoma of the stomach
- •Treated with palliative intent
- •At least one index symptom such as bleeding, obstruction or pain
- •No prior abdominal radiotherapy
- •Not on chemotherapy
排除标准
- •Patients treated with radical intent
- •Previous abdominal radiotherapy
- •Patients on chemotherapy
结局指标
主要结局
Response of bleeding to radiotherapy
时间窗: At the 12th fraction of radiotherapy and at one month post radiotherapy
Percentage of patients who do not require blood transfusion after radiotherapy
次要结局
- Number of patients who develop anorexia, nausea, vomiting as per common toxicity criteria v3.0(within the first 14 days from start of radiotherapy)