Plain-English translation of NCT04749108 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · 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.
This trial is testing whether people with locally advanced rectal cancer who respond very well to initial chemotherapy (using Folfirinox) can skip radiation therapy and proceed directly to surgery, or whether they should still receive chemotherapy combined with radiation followed by surgery. The goal is to avoid unnecessary radiation in patients whose tumors shrink significantly, while still curing the cancer.
Standard treatment for advanced rectal cancer exposes all patients to pelvic radiation, which can cause long-term side effects even in patients whose tumors respond well to chemotherapy alone. This trial tests whether a more personalized approach—giving radiation only to those who truly need it—can reduce harm without compromising cure rates.
You likely qualify if…
You likely don't qualify if…
After completing initial chemotherapy, you will have imaging tests to assess how well your tumor responded. If you are a very good responder, you will be randomly assigned to one of two groups: either proceed to surgery within 4–6 weeks, or receive a combined chemotherapy and radiation treatment (5 weeks of daily radiation plus oral capecitabine) followed by surgery 7 weeks later. Throughout the study, you will have regular check-ups, blood tests, and imaging to monitor your progress and any side effects.
AI-generated summary from trial data · Sep 20, 2026 · Not medical advice
France