FRAMEWORK-CRC: Fruquintinib Real-World Outcomes in mCRC - A Prospective Study of One-Year Progression-Free Survival and Overall Survival in Polish Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 10
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Metastatic colorectal cancer or mCRC is a cancer that starts in the parts of the large intestine (the colon or rectum) and has already spread to other parts of the body. This cancer can be hard to treat because it can behave differently from one person to another. Over time, treatments may stop working, and side effects can build up. In later treatment stages, there are only a few standard medicine options available. Because of this, studies often look at both how long people live and how treatment affects quality of life.
The main aim of this study is to see how long adults in Poland with mCRC live without their cancer getting worse (progression-free survival or PFS) when they receive fruquintinib after at least two previous treatments. Fruquintinib (TAK 113) is a medicine taken by mouth that is designed to slow tumor growth.
Other aim is to find out how long adults in Poland with mCRC live while being treated with fruquintinib (overall survival or OS). The study also wants to record how fruquintinib is used in routine care in adults with mCRC in Poland (for example when treatment starts, changes in doses, and how long treatment continues). Another aim is to learn about people with mCRC, such as their medical history and past treatment as well as their quality of life while they are in the study.
The study will look at data already existing in the participants' medical charts.
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
- •Adult participants (aged 18 years and older) with mCRC who are eligible for treatment with fruquintinib under the national drug program B.4 and will receive fruquintinib as third or subsequent line treatment after progression on or intolerance to trifluride/tipiracil.
- •Participants who signed informed consent to participate in the study at the time of enrollment and prior to the fruquintinib treatment initiation.
- •Participants for whom adequate medical records are available to support the data collection requirements.
排除标准
- •1. Participant currently participates or plans to participate in an interventional clinical trial.
研究组 & 干预措施
Participants with mCRC
Adult participants with metastatic colorectal cancer (mCRC) who initiate treatment with fruquintinib under reimbursement program will be included. Participants will be observed for 12 months after treatment initiation, or until death.
干预措施: No intervention (Other)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to 12 months
PFS as assessed by the Investigator is defined as the time from the first dose of fruquintinib until the first disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death for any reason. Participants without disease progression will be censored at the time of the last assessment of disease status.
次要结局
- Overall Survival (OS)(Up to 12 months)