Recruiting

Two treatment approaches for advanced rectal cancer

Plain-English translation of NCT04215731 on ClinicalTrials.gov ↗ · Source last updated March 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 trial is testing whether a newer chemotherapy combination called mFOLFOXIRI plus bevacizumab works better than the standard treatment approach for advanced rectal cancer. Depending on how you respond to the initial chemotherapy, you may or may not need radiation therapy before surgery. The trial will compare how well each approach helps people with this serious type of rectal cancer.

Advanced rectal cancer is difficult to treat and has a high risk of coming back after surgery. Researchers want to see if this newer medication combination, with its flexible approach to radiation, can improve survival and quality of life compared to the standard treatment that everyone receives.

Do you qualify?

You likely qualify if…

you are between 18 and 70 years old
you have been diagnosed with adenocarcinoma of the rectum (a type of rectal cancer) that is locally advanced but has not spread to distant organs
your cancer shows high-risk features on an MRI scan, such as involvement of the tissue surrounding the tumor, very large tumor size, or affected lymph nodes
you have not received any prior chemotherapy or cancer treatment for colorectal cancer
you are in good enough health to tolerate chemotherapy and possible radiation, as assessed by your doctor

You likely don't qualify if…

you have evidence that your cancer has spread to distant parts of your body (lungs, liver, brain, etc.)
you have had radiation therapy to your pelvis in the past
you have had a heart attack, severe heart disease, or significant heart rhythm problems within the past year
you have a history of blood clots, stroke, or pulmonary embolism within the past year
you are currently taking blood-thinning medications or high-dose antiplatelet therapy

What participation looks like

If you enroll, you will be randomly assigned to one of two treatment groups. Both groups receive chemotherapy through an IV over several months. In the first group, you receive the newer medication combination every two weeks for 6 cycles, then have an MRI scan to see how well the tumor responded — if it looks better, you may skip radiation and go straight to surgery; if not, you receive radiation with concurrent chemotherapy before surgery. In the second group, you receive standard chemotherapy for 4 cycles, then everyone receives radiation combined with chemotherapy before surgery. Throughout the trial, you'll have regular clinic visits, blood tests, and imaging scans to monitor your health and how well the treatment is working.

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

Trial locations(1 site)

China

The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong

View full record on ClinicalTrials.gov