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Background <p>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.</p> Methods and design <p>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 mismatch-repair proficient and/or microsatellite stable tumor can be included.</p> <p>Preoperative treatment in Arm A is performed for a maximum of 6 biweekly cycles of FOLFOX/FOLFOXIRI or for a maximum of 4 triweekly cycles CAPOX (i.e., appr. 12 weeks). Patients in both arms should undergo quality-controlled surgery of the primary tumor, performed as complete mesocolic excision.</p> <p>Patients will be followed up with regard to relapse, survival and if applicable subsequent anti-cancer treatments until death or for at least 5 years after randomization, whichever date is earlier.</p> Discussion <p>The PROTECTOR / FIRE‑10 trial compares preoperative systemic therapy to upfront surgery (with stage-guided adjuvant therapy) in patients with locally advanced colon cancer.</p> Trial registration <p>This study is registered with clinicaltrials.gov (NCT06899477) and EudraCT (2023-508076-11-00).</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月20日

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  • Robert Siegel,
  • Luca Dittrich,
  • Julius Plewe,
  • Timm Denecke,
  • Jakob Leonhardi,
  • Andrea Tannapfel,
  • Anke Reinacher-Schick,
  • Nathanael Raschzok,
  • Igor Maximilian Sauer,
  • Johannes Lauscher,
  • Sylvie Lorenzen,
  • Thorsten Götze,
  • Ivan Jelas,
  • Arndt Stahler,
  • Annika Kurreck,
  • Alexej Ballhausen,
  • Benjamin Nils Ostendorf,
  • Oliver Haase,
  • Johann Pratschke,
  • Sebastian Stintzing,
  • Dominik Paul Modest

摘要

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 mismatch-repair proficient and/or microsatellite stable tumor can be included.

Preoperative treatment in Arm A is performed for a maximum of 6 biweekly cycles of FOLFOX/FOLFOXIRI or for a maximum of 4 triweekly cycles CAPOX (i.e., appr. 12 weeks). Patients in both arms should undergo quality-controlled surgery of the primary tumor, performed as complete mesocolic excision.

Patients will be followed up with regard to relapse, survival and if applicable subsequent anti-cancer treatments until death or for at least 5 years after randomization, whichever date is earlier.

Discussion

The PROTECTOR / FIRE‑10 trial compares preoperative systemic therapy to upfront surgery (with stage-guided adjuvant therapy) in patients with locally advanced colon cancer.

Trial registration

This study is registered with clinicaltrials.gov (NCT06899477) and EudraCT (2023-508076-11-00).