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

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.

NCT Number	NCT07472868
Lead Sponsor	J. W. A. Burger Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Conditions	Locally Advanced Rectal Carcinoma
Enrollment	394 participants
Start Date	2026-03-03
Primary Completion	2030-03-02 (estimated)
Study Completion	2034-03-02 (estimated)
Updated on ClinicalTrials.gov	2026-03-16