Modified FOLFOXIRI Plus Targeted Therapy as First-Line Treatment for Advanced Metastatic Colorectal Cancer: A Prospective Phase II Study

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a modified FOLFOXIRI chemotherapy regimen combined with targeted therapy for treating metastatic colorectal cancer (MCRC). This Phase II trial aims to reduce the high toxicity typically seen with standard FOLFOXIRI while maintaining its therapeutic benefits. The main goal is to measure the objective response rate and monitor both immediate and delayed side effects. Additional goals include assessing the treatment's role in converting tumors to operable status and studying survival outcomes. The treatment involves a modified FOLFOXIRI regimen given every two weeks for up to 12 cycles (6 months). This includes oxaliplatin, irinotecan, and 5-fluorouracil delivered intravenously with doses adjusted to reduce toxicity. Targeted therapy depends on tumor genetics and location: patients with certain gene types and left-sided tumors receive anti-EGFR drugs (panitumumab or cetuximab), while others get bevacizumab. Patients over 55 receive preventive G-CSF to reduce neutropenia risk. Dose reductions and treatment discontinuation occur if severe side effects develop. Participants will be closely monitored through regular disease assessments every 8 weeks during treatment and every 3 months afterward, using imaging and clinical criteria to judge tumor response. Quality of life will be evaluated with questionnaires. Safety will be tracked using standardized criteria after each treatment cycle. Survival outcomes will be analyzed over up to 24 months. Participants may undergo surgery if their tumor responds well after 8 cycles. The total study duration includes treatment and follow-up, with careful evaluation of side effects and treatment effectiveness.

Modified FOLFOXIRI Plus Target Therapy as a First Line Treatment for Advanced Colorectal Cancer a Prospective Phase Two Study