A Study of Fruquintinib in Adults With Metastatic Colorectal Cancer in Poland
ConditionMetastatic Colorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTakeda
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Eligible adult participants (aged 18 years and older) with mCRC who initiate treatment with fruquintinib under the national drug program (DP) (reimbursement program).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionNo Intervention will be administered in this study.
Treatment groups
110 Participants
are divided into 1 treatment groupGroup A: Participants with mCRC1 intervention
Trial outcomes
Primary outcomes
1
Progression Free Survival (PFS)
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.
Time frame
Up to 12 monthsSecondary outcomes
1
Overall Survival (OS)
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.
Time frame
Up to 12 months Source ClinicalTrials.gov