Plain-English translation of NCT01955837 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Colorectal cancer research guide →Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial studied trifluridine/tipiracil (), a new oral medication, in Asian patients whose colorectal cancer had progressed despite receiving at least two rounds of standard chemotherapy. About two-thirds of participants received the medication while one-third received a placebo (inactive pill), with neither group knowing which they were getting. Researchers examined whether this treatment could extend survival and help patients live better lives.
When colorectal cancer spreads to other parts of the body and stops responding to standard chemotherapy, patients have very few options left. This trial was designed to determine whether this medication could offer hope to patients who have already exhausted conventional treatments.
Participants were randomly assigned to either receive the new medication or a placebo pill to take by mouth, with neither they nor their doctors initially knowing which group they were in. They attended regular clinic visits so doctors could monitor how well the treatment worked, check for side effects, and ensure their organs were functioning properly. The trial continued until the medication stopped working, side effects became unbearable, or the patient decided to withdraw.
AI-generated summary from trial data · Oct 12, 2026 · Not medical advice
China
South Korea
Thailand