COLONG: Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Proportion of patients with a DoT to Stivarga of more than 4 months versus total study sample
研究概览
简要总结
The aim of this local NIS(Non-Interventional Study) is to determine the proportion of Belgian patients with a duration of treatment(DoT) to Stivarga of 4 months or more in relation to the total population of Belgian metastatic colorectal cancer(mCRC) patients who were treated with Stivarga between the 1st of July 2015 and 31 July 2017. In addition, this study aims to describe the clinical characteristics of Belgian patients with a short- or long-term DoT to Stivarga.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Male or female patients ≥ 18 years of age.
- •Patients who suffer from mCRC and who started treatment with Stivarga between the 1st of July 2015 and 31 July
- •Patients who already received alternative treatment options before Stivarga for the treatment of mCRC or who were not eligible for other treatment options.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 at start of Stivarga treatment.
- •Sufficient kidney, liver and bone marrow function start of Stivarga treatment.
- •Life expectancy ≥ 3 months at start of Stivarga treatment
排除标准
- •Patients participating in an investigational program/clinical trial with interventions outside of routine clinical practice during the observational period.
研究组 & 干预措施
Regorafenib_DoT ≥ 12 months
DoT ≥ 12 months
干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)
Regorafenib_DoT<4 months
DoT < 4 months
干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)
Regorafenib_4 months ≤ DoT < 12 months
4 months ≤ DoT < 12 months
干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)
结局指标
主要结局
Proportion of patients with a DoT to Stivarga of more than 4 months versus total study sample
时间窗: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
ECOG performance status (0, 1)
时间窗: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
ECOG: Eastern Cooperative Oncology Group
Primary site of disease
时间窗: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Rectum, Left-sided colon, Right-sided colon, Colon and rectum, Transverse, Unknown (in colon)
Tumor resection (yes, no, unknown)
时间窗: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Specific site of metastasis
时间窗: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Lung, Liver, Bone, Extraregional nodes, Peritoneum, Multiple, Unknown
KRAS mutation (yes, no, unknown)
时间窗: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
RAS mutation (yes, no, unknown)
时间窗: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
BRAF mutation (yes, no, unknown)
时间窗: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
次要结局
- Start date of Stivarga treatment(Retrospective chart review from 1-Jul-2015 to 1-Dec-2017)
- Number of prior treatment lines for metastatic cancer larger than 3 (yes, no, unknown)(Retrospective chart review from 1-Jul-2015 to 1-Dec-2017)
- Reason for discontinuation of Stivarga treatment(Retrospective chart review from 1-Jul-2015 to 1-Dec-2017)
- Subsequent mCRC treatment(Retrospective chart review from 1-Jul-2015 to 1-Dec-2017)
- Last daily Stivarga dose(Retrospective chart review from 1-Jul-2015 to 1-Dec-2017)
- Duration of treatment (months)(Retrospective chart review from 1-Jul-2015 to 1-Dec-2017)