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.
18 years or older
WHO performance score 0-1.
Fit for (modified dose) triple chemotherapy (FOLFOXIRI)
Histopathological confirmed rectal cancer. (Lower border of the tumour located on or below the sigmoidal take-off as established on MRI of the pelvis.)
Evidence of metastatic disease at time of inclusion or within six months prior to inclusion except for patients with enlarged iliac or inguinal lymph nodes and non-specific lung noduli.
Homozygous DPD deficiency.
Any chemotherapy within the past 6 months.
Any contraindication for the planned systemic therapy (e.g., severe allergy, pregnancy, kidney dysfunction and thrombocytopenia), as determined by the medical oncologist.
J. W. A. Burger
Lead sponsor
Catharina Ziekenhuis Eindhoven
Sponsor institution
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator