Status: Not yet recruiting
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.
Participants needed: 394
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: J. W. A. BurgerUpdated: Mar 16, 2026Locations: 1
Eligibility criteria
18 years or older [+9]
Evidence of metastatic disease at time of inclusion or within six months prior t... [+8]