PRODIGE 108 - COFRUQ Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer

What this Trial Is About

Researchers are studying patients with metastatic colorectal cancer to identify clinical and biological factors that predict how well fruquintinib works in real-world settings. The study aims to confirm survival and safety results seen in previous trials and to better understand treatment outcomes, especially in older patients aged 70 and above, who have been underrepresented in earlier research. This cohort is designed to optimize treatment pathways by pinpointing patients who may benefit most from fruquintinib. Participants will receive fruquintinib, an oral drug that targets specific blood vessel growth receptors, given as 5 mg daily for 21 days followed by a 7-day break. This cycle repeats until the cancer progresses, unacceptable side effects occur, the patient dies, or the patient chooses to stop treatment. The study includes patients treated under compassionate use or after marketing authorization in France, integrating routine clinical practice data. During the study, participants will be monitored for overall survival up to one year after starting treatment, which is the main outcome measured. Additional monitoring includes progression-free survival within the same timeframe. The study involves collecting biological samples like circulating tumor DNA and tumor tissue blocks. Safety, survival, and treatment response data will be gathered to support understanding of fruquintinibs effects in everyday clinical use. The study is expected to continue until the end of 2031.

Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer