Testing Extra Chemotherapy for Colorectal Cancer Patients With Remaining Disease Markers

Plain-English translation of NCT06197425 on ClinicalTrials.gov ↗ · Source last updated May 2026 · Translation generated August 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing whether patients with stage III colorectal cancer who have finished surgery and initial chemotherapy but still have signs of disease in their blood should receive additional chemotherapy. Researchers are comparing two medication options—trifluridine tipiracil and FOLFIRI—against careful monitoring alone to see which approach best prevents cancer from returning.

Currently, doctors don't know the best way to treat patients whose blood tests show signs that cancer cells may still be present after completing standard treatment. This trial aims to find out whether giving extra medication to these patients helps them stay cancer-free longer.

Do you qualify?

You likely qualify if…

you have been diagnosed with stage III colon or upper rectal cancer, or stage II with high-risk features
you have completed surgery and standard chemotherapy (FOLFOX or CAPOX) for your cancer
blood tests show that cancer cells are likely still present after your chemotherapy ended
you are between 18 and 80 years old and in reasonably good overall health
your blood counts, liver function, and kidney function are healthy enough to handle chemotherapy
you have a tumor sample available for genetic testing

You likely don't qualify if…

you have already received trifluridine tipiracil or irinotecan in the past 5 years
you have a genetic condition called DPD deficiency or Gilbert's disease that affects how your body processes certain chemotherapy drugs
you are pregnant, breastfeeding, or planning to become pregnant
you have uncontrolled health problems or other active cancers
you are taking St. John's Wort or brivudine, which interact with the study medications

What participation looks like

If you qualify, you will be randomly assigned to one of three groups: receive FOLFIRI chemotherapy, receive trifluridine tipiracil chemotherapy, or undergo close monitoring without additional chemotherapy. You will have regular clinic visits for blood tests, scans, and physical exams to track how you're doing. The trial will follow you for several years to see whether the extra medication helps prevent your cancer from returning compared to monitoring alone.

AI-generated summary from trial data · Aug 11, 2026 · Not medical advice

Trial locations(1 site)

France

Chu Dijon Bourgogne, Dijon