# Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk

Source: https://onco.cc/trials/nct07472868/  
OnCo record `nct07472868` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of FOLFOXIRI, cAPOX (capecitabine, oxaliplatin) and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by J. W. A. Burger, not yet recruiting.

## Summary

Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT07472868 by J. W. A. Burger, with a registry enrolment figure of 394 participants, started 2026-03-03 and due to reach its primary completion in 2030-03-02. Interventions recorded: FOLFOXIRI; CAPOX; FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin); Chemoradiotherapy; Total mesorectal excision (+/- IORT); Watch-and-wait approach. Conditions listed: Locally Advanced Rectal Carcinoma. Primary outcome: Complete response. Colorectal eligibility wording from the registry: "* Histopathological confirmed rectal cancer". Sites: Netherlands. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-24
- Also known as: MEND-IT II
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT07472868
- Phase: 3
- Setting: MEND-IT II: Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy, Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer.
- Sponsor: J. W. A. Burger
- Enrolled: 394

## Sources

- ClinicalTrials.gov NCT07472868: https://clinicaltrials.gov/study/NCT07472868

## Connected records

- cancers: [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/), [Platinum agents](https://onco.cc/technologies/platinum/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- drugs: [CAPOX (capecitabine, oxaliplatin)](https://onco.cc/drugs/capox/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/), [FOLFOXIRI (5-FU, leucovorin, oxaliplatin, irinotecan)](https://onco.cc/drugs/folfoxiri/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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