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

Summary

The aim of this clinical trial is to compare triplet induction therapy (FOLFOXIRI) with doublet induction therapy (CAPOX/FOLFOX), followed by chemoradiotherapy and either surgery or a watch-and-wait approach, in patients with high-risk locally advanced rectal cancer. The primary questions it seeks to address are whether triplet induction therapy results in higher complete response rates, improved quality of life, and better long-term oncological outcomes compared to doublet induction therapy, despite the anticipated increased risk of toxicity.

Timeline

Start

2026-03-03

Primary completion

2030-03-02

Completion

2034-03-02

Publications

• Banken E, Borg M, van Hellemond IEG, van Ravensteijn SG, Peulen HMU, Verrijssen AE, Nederend J, Daniels-Gooszen AW, van Oudheusden TR, van Lijnschoten G, Bloemen JG, Rutten HJT, van Westreenen HL, de Groot JWB, Verhoef C, Tanis PJ, Grotenhuis BA, Aalbers AGJ, Werter IM, Hartogh MDD, Douma JAJ, Calon TGA, Iersel LBJV, Beets GL, Tuynman JB, Intven MPW, van Kuijk SMJ, Berbee M, Buffart TE, Roodhart JML, Burger JWA; Dutch Colorectal Cancer Group. A national, multicentre, randomised, controlled, parallel-arms, phase III clinical trial of neoadjuvant FOLFOXIRI and chemoradiotherapy versus neoadjuvant CAPOX/FOLFOX and chemoradiotherapy in patients with high-risk locally advanced rectal cancer: study protocol of the MEND-IT II trial. BMC Cancer. 2026 May 18;26(1):838. doi: 10.1186/s12885-026-16072-5.

Drugs

Indications