# 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

> **NCT07472868** · PHASE3 · NOT_YET_RECRUITING · sponsor: **J. W. A. Burger** · enrollment: 394 (estimated)

## Conditions studied

- Locally Advanced Rectal Carcinoma

## Interventions

- **DRUG:** FOLFOXIRI
- **DRUG:** CAPOX
- **DRUG:** FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
- **RADIATION:** Chemoradiotherapy
- **PROCEDURE:** Total mesorectal excision (+/- IORT)
- **DIAGNOSTIC_TEST:** Watch-and-wait approach

## Key facts

- **NCT ID:** NCT07472868
- **Lead sponsor:** J. W. A. Burger
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-03-03
- **Primary completion:** 2030-03-02
- **Final completion:** 2034-03-02
- **Target enrollment:** 394 (ESTIMATED)
- **Last updated:** 2026-03-16

## Collaborators

- [object Object]

## Primary source

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

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07472868, "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". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT07472868. Licensed CC0.

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