Non-interventional Observational Study of Helical Tomotherapy for Oligometastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Metabolic complete remission rate
研究概览
简要总结
Patients with oligometastatic colorectal cancer (5 metastases or less) receive a combination of systemic treatment and often local treatment, such as surgery, radiofrequency ablation and more recently stereotactic body radiotherapy. The aim of this study is to register the results and side effects of stereotactic body radiotherapy (SBRT) by means of helical tomotherapy in the treatment of oligometastatic colorectal cancer.
The trial has two cohorts. Patients in cohort I get consolidation SBRT after best response on first line chemotherapy. Patients in cohort II get SBRT when there is progression under, or no indication for (further) chemotherapy. The primary endpoint is to evaluate the metabolic complete remission rate three months after the start of radiotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with (residual) oligometastatic CRC: ≤ 5 mets
- •Primary tumor treated with curative intention (surgery, radiotherapy, chemoradiotherapy)
- •Functional liver volume > 1000cc if livermets, lung DLCO > 30% if lungmets.
- •No Child B or C liver cirrhosis
- •No contra-indications for radiation of all metastatic CRC (= no violation of constraints of organs at risk (OAR))
- •No mets from another carcinoma
- •Age > 18 years
- •WHO-PS ≤ 2
排除标准
- 未提供
结局指标
主要结局
Metabolic complete remission rate
时间窗: Three months
次要结局
- Local control(Three to thirty six months)
- Acute toxicity(Three months)
- Progression free survival(Three to thirty six months)
- Late toxicity(Three to thirty six months)
- Survival(Three to thirty six months)
研究者
Mark De Ridder
Head of Radiotherapy Department
Universitair Ziekenhuis Brussel