Triple chemo may help rectal cancer patients avoid surgery

NCT ID NCT07472868

First seen Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This Phase 3 trial tests whether a three-drug chemotherapy combination (FOLFOXIRI) works better than the standard two-drug combination (CAPOX/FOLFOX) for people with high-risk locally advanced rectal cancer. Both groups also receive chemoradiation, and then either surgery or a watch-and-wait approach. The goal is to see if the stronger chemo leads to more complete tumor disappearances and better quality of life, despite a higher risk of side effects. The study plans to enroll 394 participants.

What this could mean

Our plain-language read of the trial. This is informational only โ€” not medical advice or a prediction.

Active substance
FOLFOXIRI (a combination of three chemotherapy drugs: irinotecan, oxaliplatin, and 5-fluorouracil) compared to CAPOX/FOLFOX (two-drug combinations)
What this could lead to
If successful, this could show that a stronger three-drug chemo combination leads to more tumors disappearing completely, allowing some patients to avoid surgery and have a better quality of life.
What could go wrong
This is an early-stage Phase 3 trial that hasn't started recruiting yet. The stronger chemo may cause more side effects, and it's not yet known if it will improve long-term outcomes or just increase toxicity.

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Conditions

The condition(s) this trial relates to.

Pathologic Complete Response rectal cancer rectal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Catharina Hospital Eindhoven

    Eindhoven, North Brabant, 5623 EJ, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.