A Study of Fruquintinib in Adults With Metastatic Colorectal Cancer in Poland
FRAMEWORK-CRC: Fruquintinib Real-World Outcomes in mCRC - A Prospective Study of One-Year Progression-Free Survival and Overall Survival in Polish Patients
1 other identifier
observational
110
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2026
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2026
CompletedFirst Posted
Study publicly available on registry
June 3, 2026
CompletedStudy Start
First participant enrolled
August 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
September 22, 2026
September 1, 2026
1.6 years
May 29, 2026
September 17, 2026
Conditions
Outcome Measures
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.
Up to 12 months
Secondary Outcomes (1)
Overall Survival (OS)
Up to 12 months
Study Arms (1)
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.
Interventions
Eligibility Criteria
Eligible adult participants (aged 18 years and older) with mCRC who initiate treatment with fruquintinib under the national drug program (DP) (reimbursement program).
You may qualify if:
- 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.
You may not qualify if:
- \. Participant currently participates or plans to participate in an interventional clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (10)
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej Curie, Oddzial Onkologii Klinicznej i Immunoonkologii z Pododdzialem Dziennym i Izb Przyjec
Poznan, Greater Poland Voivodeship, 61-866, Poland
Centrum Onkologii im. prof. Franciszka Lukaszczyka w Bydgoszczy, Ambulatorium Chemoterapii
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Onkologii
Krakow, Lesser Poland Voivodeship, 31-501, Poland
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie, Klinika Chorob Metabolicznych i Immunoonkologii, Oddzial Onkologii Klinicznej
Lublin, Lublin Voivodeship, 20-400, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Onkologii i Radioterapii
Warsaw, Masovian Voivodeship, 02-034, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego w Opolu, Klinika Onkologii, Odcinek Dzienny
Opole, Opole Voivodeship, 45-061, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu, Oddzial Onkologiczny z Pod. Dziennej Chemioterapii
Przemyśl, Podkarpackie Voivodeship, 37-700, Poland
Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie w Bialymstoku, Oddzial Onkologii Klinicznej im. dr E. Pileckiej z pododdzialem Chemioterapii Dziennej
Bialystok, Podlaskie Voivodeship, 15-027, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Oddzial w Gliwicach, Oddzial Chemioterapii Dziennej
Gliwice, Slskie, 44-102, Poland
Zachodniopomorskie Centrum Onkologii, Oddzial Onkologii Klinicznej
Szczecin, West Pomeranian Voivodeship, 71-730, Poland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2026
First Posted
June 3, 2026
Study Start
August 13, 2026
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2028
Last Updated
September 22, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.