PROTECTOR / FIRE‑10: study protocol for a prospective, randomized, open-label, multicenter phase III trial to investigate the efficacy of preoperative systemic therapy in advanced colon cancer
Abstract
BACKGROUND: Standard of care for non-metastatic colon cancer is surgery followed by stage-guided adjuvant therapy and/or structured follow-up. Upfront surgery in resectable colon cancer is irrespective of local T/N stage, whereas adjuvant systemic therapy is recommended according to pathological staging. The role of neoadjuvant chemotherapy remains unclear. Whereas perioperative systemic therapy in colon cancer seems to be safe and may lead to pathologic downstaging, evidence on improved survival and quality of life remains scarce. The PROTECTOR / FIRE‑10 trial aims to generate evidence that perioperative systemic therapy improves survival without compromising quality of life in locally advanced, mismatch-repair proficient colon cancer patients. METHODS AND DESIGN: Open-label, randomized, controlled, multicenter, phase III study with two parallel arms. Patients with locally advanced colon or upper rectal cancer staged cT3-4 and/or cN+ are randomized in a 2:1 fashion (favoring preoperative therapy) to investigate the efficacy, patient reported quality of life, and safety of preoperative therapy followed by surgery (Arm A) versus direct surgery followed by non-study specific stage-guided adjuvant therapy (Arm B). Stratification during randomization will be performed according to the following parameters: Fit for mFOLFOXIRI vs. mFOLFOX/CAPOX vs. 80%-mFOLFOX/CAPOX, ECOG 0 vs. ECOG 1-2, and left-sided primary vs. right-sided primary tumor. Only patients with confirmed…
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