Plain-English translation of NCT05526079 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing a new approach to rectal cancer treatment for patients with early-stage disease. Instead of having surgery after chemotherapy and radiation, patients whose tumors shrink completely or nearly completely will be monitored closely with imaging and scans—a strategy called 'watchful waiting.' The goal is to see if this approach can control the cancer while avoiding surgery and helping patients maintain a better quality of life.
Traditional rectal cancer treatment requires surgery after chemotherapy and radiation, which can affect a patient's quality of life and bodily functions. This trial exists to test whether some patients—those whose tumors respond completely to the medication and radiation—might safely skip surgery and instead be watched carefully for any signs the cancer returns.
You would receive six rounds of intravenous chemotherapy (FOLFOX) given every two weeks, followed by a 3-week rest period. Then you would receive concurrent radiation therapy combined with chemotherapy pills or infusions. About 2–3 weeks after chemotherapy ends, and again 7–11 weeks after radiation ends, you would have imaging scans and endoscopic ultrasound to see how your tumor responded. If your tumor has shrunk completely or nearly completely, you would enter the 'watchful waiting' phase, which involves regular follow-up visits and imaging scans at specific time points instead of surgery. If the cancer returns during monitoring, you would then have surgery as standard treatment.
AI-generated summary from trial data · Aug 4, 2026 · Not medical advice
United States
Sponsor
Henry Ford Health System
Enrollment target
~15 participants
Started
July 2018
Primary completion
March 2026
Age range
18 Years – 95 Years
Last updated on clinicaltrials.gov in July 2026.