Metastatic Colorectal Cancer
Conditions
Brief summary
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.
Interventions
OTHERNo intervention
No Intervention will be administered in this study.
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Participants who signed informed consent to participate in the study at the time of enrollment and prior to the fruquintinib treatment initiation. 3. Participants for whom adequate medical records are available to support the data collection requirements.
Exclusion criteria
1\. Participant currently participates or plans to participate in an interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 12 months | OS is defined as the time from the first dose of fruquintinib until death for any reason within the 12-month observation period or up the 12-month observation period whichever comes first. Participants will be censored at the time of the last assessment of survival status or day 365, if later survival status assessment is available. |
Contacts
CONTACTTakeda Contact
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed