Recruiting

Chemotherapy alone versus chemotherapy plus radiation for advanced rectal cancer

Plain-English translation of NCT03875781 on ClinicalTrials.gov ↗ · Source last updated January 2026 · Translation generated June 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 study is testing whether a strong treatment called FOLFIRINOX can work just as well on its own as it does when followed by radiation therapy, for people with advanced rectal cancer that hasn't spread to distant parts of the body. Half of the participants will receive 3 months of FOLFIRINOX alone, while the other half will receive the same followed by 5 weeks of radiation therapy with another drug. After treatment, everyone will have surgery to remove the cancer.

Current standard treatment combines with radiation, but this combination is intense and can cause significant side effects. Researchers want to know if the new treatment without radiation might be equally effective while potentially causing fewer side effects, which could improve quality of life for patients.

Do you qualify?

You likely qualify if…

you have been diagnosed with rectal cancer in the middle or lower part of your rectum
your cancer is locally advanced (larger or involving nearby lymph nodes) but has not spread to distant organs
your cancer is positioned far enough from the surgical margins on imaging scans
you are 18 years old or older and in generally good health
you have not received any previous radiation therapy to your pelvis
you are able and willing to use effective birth control during and for 6 months after treatment

You likely don't qualify if…

your cancer has already spread to distant organs like the liver, lungs, or other areas
you have a very advanced tumor that invades the muscle around the anus
you have had previous radiation therapy to your pelvis
you have serious liver problems, kidney problems, or bone marrow problems that would prevent safe chemotherapy
you have inflammatory bowel disease or other medical conditions that would make radiation therapy unsafe

What participation looks like

If you join this trial, you will be randomly assigned to one of two groups. Both groups will receive infusions every two weeks for 3 months (six treatment cycles). One group will then receive 5 weeks of daily radiation therapy combined with another pill. Before surgery, you'll have imaging scans to see how well the treatment worked. After preoperative treatment is complete, you'll have surgery to remove the cancer. The study will follow you for 3 years after you start treatment to monitor how well you recover and whether the cancer returns.

AI-generated summary from trial data · Jun 6, 2026 · Not medical advice

Trial locations(1 site)

France

BENOIST, Le Kremlin-Bicêtre, Île-de-France Region