Palliative Radiotherapy Followed by Chemotherapy Against Palliative Surgery in Patients With Rectal Cancer With Unresectable Synchronous Distant Metastases
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- percentage of patients not requiring palliative surgery during the follow-up
研究概览
简要总结
Short course palliative radiotherapy (5x5Gy)to the pelvis in patients with symptomatic rectal tumours and with unresectable metastases may prevent palliative surgery with a good palliative outcome.The consolidating chemotherapy of XELOX may increase the efficacy of irradiation.
详细描述
Patients with symptomatic rectal cancer and unresectable metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy after one week. Investigators arbitrarily assumed that palliative radiotherapy to the pelvis can replace the immediate surgery if at least 30% of patients would avoid delayed surgery until the end of their lives, or for at least 18 months in the case of long-term survival.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary carcinoma of the rectum (Lower border of tumour ≤ 10 cm from anal verge)
- •Occurrence of subjective clinical symptoms of the primary tumor
- •Non-resectable synchronous distant metastases. The decision of non-resectable metastases will be made at multidisciplinary clinical meetings.
排除标准
- •Obstruction of the gastrointestinal tract
- •Previously constructed stoma
- •prior radiotherapy of the pelvis
结局指标
主要结局
percentage of patients not requiring palliative surgery during the follow-up
时间窗: every three months
次要结局
- The rate of early toxicity of radiotherapy according to the NCI CTCAE (version 3.0)(3 months)
- Palliative effect of radiotherapy(every three months)
- Time from palliative radiotherapy to delayed palliative surgery(18 months)
- Determination of prognostic factors indicating the need for immediate palliative surgery.(18 months)