Phase III Study Comparing Post-Surgery Chemotherapy Versus Follow-Up in Adults With Metastatic Colorectal Cancer

What this Trial Is About

Researchers are investigating the effects of additional chemotherapy treatment after surgery or ablation in patients with metastatic colorectal cancer whose tumor lesions have been definitively treated. This phase III, open-label, randomized, controlled trial aims to compare the effectiveness, quality of life, and safety of mFOLFOXIRImFOLFOX-6 chemotherapy against active follow-up without additional chemotherapy. The study also includes a translational research component to analyze tumor biopsies and blood samples for disease relapse markers. Patients are assigned randomly in a 21 ratio to receive either active chemotherapy mFOLFOXIRI, mFOLFOX6, FOLFIRI, or CAPOX for up to six months or structured follow-up without chemotherapy. Chemotherapy regimens involve intravenous infusions and oral medications administered in cycles every two or three weeks, with a maximum of 12 cycles for most treatments. After treatment or follow-up, participants continue with structured monitoring for up to five years. Participants undergo re-assessments every three months during the first two years, including CT or MRI scans of the thorax and abdomen, blood tests, and quality of life evaluations to detect disease relapse. After two years without relapse, follow-up intervals extend to every six months. The primary outcome measured is progression-free survival at 24 months, with secondary outcomes including overall survival, lesion control, adverse events, and quality of life monitored for up to five years following randomization.

Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)