Plain-English translation of NCT04389086 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 patients with recurrent rectal cancer benefit from receiving induction chemotherapy—an extra round of chemotherapy given first—before the standard radiation and chemotherapy combination followed by surgery. Right now, doctors typically treat this situation with radiation and chemotherapy together, then surgery. The study wants to know if the additional upfront chemotherapy improves outcomes.
Rectal cancer that comes back after previous treatment is challenging and often requires a combination of chemotherapy, radiation, and surgery to have the best chance of cure. Researchers believe that adding an extra round of chemotherapy at the beginning might help destroy cancer cells more effectively and improve survival, but this hasn't been proven yet.
You likely qualify if…
You likely don't qualify if…
If you join this trial, you will be randomly assigned to one of two groups. One group receives extra chemotherapy first, followed by standard radiation and chemotherapy, and then surgery. The other group receives standard radiation and chemotherapy followed by surgery without the extra chemotherapy upfront. You will have regular visits with your cancer care team for imaging tests, blood work, and clinical check-ups throughout the treatment phase, and follow-up visits afterward to monitor your recovery and long-term health.
AI-generated summary from trial data · Jun 18, 2026 · Not medical advice
Belgium
Netherlands