Fruquintinib in Patients With Metastatic Colorectal Cancer
Recruiting · NCT06787105 · Observational (researchers observe without assigning treatment) · Lead sponsor: iOMEDICO AG
View the official record on ClinicalTrials.gov →What this trial is about
FRUQUENT is an observational study in Germany. The goal of the study is to evaluate how well Fruquintinib works to treat patients with metastatic colorectal cancer that have previously been treated with available standard therapies. To this end, it will be analyzed how well patients respond to the therapy in the clinical routine. Further points of interest to the study are survival data, safety data, the use of medical care facilities, and the quality of life of patients treated with Fruquintinib. Participants will be treated as decided by the treating physician and according to their routine practice. FRUQUENT is accompanied by a translational research project combining real-world clinical data with foundational research to stratify patient collectives in regards to the therapeutic benefit of fruquintinib.
Who can take part
Inclusion criteria
- Aged 18 years or older.
- Indication and decision for therapy with fruquintinib in accordance with the current German SmPC of fruquintinib as monotherapy for patients with mCRC.
- Prior treatment with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan based chemotherapies, anti VEGF therapy, and if RAS wild-type, anti EGFR therapy.
- Progression on or intolerance to treatment with either trifluridine/tipiracil and/or regorafenib.
- Other criteria according to current SmPC.
- Signed written informed consent.\* \* Patients are allowed to be enrolled up to 6 weeks after their first dose of fruquintinib. These patients cannot participate in the PRO assessments.
Exclusion criteria
- Participation in an interventional clinical trial (except follow-up) within 30 days prior to enrollment or start of treatment with fruquintinib, whatever comes first.
- Contraindications according to current SmPC.
Where it is running
1 location listed.
- Onkologische Schwerpunktpraxis - Hanover, Lower Saxony, Germany