BMC Cancer (Mar 2024)

mFOLFIRINOX versus mFOLFOX 6 as adjuvant treatment for high-risk stage III colon cancer - the FROST trial: study protocol for a multicenter, randomized controlled, phase II trial

  • Kyung-Ha Lee,
  • In Jun Yang,
  • Gi Won Ha,
  • Jaeim Lee,
  • Youn Young Park,
  • Suk Hwan Lee,
  • Jong Min Lee,
  • Jung Hoon Bae,
  • Eun Jung Park,
  • Hyungjin Kim,
  • Keun Young Kim,
  • Sanghyung An,
  • Ik Yong Kim,
  • Ji Yeon Kim

DOI
https://doi.org/10.1186/s12885-024-11939-x
Journal volume & issue
Vol. 24, no. 1
pp. 1 – 8

Abstract

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Abstract Background High-risk stage III colon cancer has a considerably poorer prognosis than stage II and low-risk stage III colon cancers. Nevertheless, most guidelines recommend similar adjuvant treatment approaches for all these stages despite the dearth of research focusing on high-risk stage III colon cancer and the potential for improved prognosis with intensive adjuvant treatment. Given the the proven efficacy of triplet chemotherapy in metastatic colorectal cancer treatment, the goal of this study is to evaluate the oncologic efficacy and safety of mFOLFIRINOX in comparison to those of the current standard of care, mFOLFOX 6, as an adjuvant treatment for patients diagnosed with high-risk stage III colon cancer after radical resection. Methods This multicenter, randomized (1:1), open-label, phase II trial will assess and compare the effectiveness and toxicity of mFOLFIRINOX and mFOLFOX 6 in patients with high-risk stage III colon cancer after radical resection. The goal of the trial is to enroll 312 eligible patients, from 11 institutes, aged between 20 and 70 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, or between 70 and 75 with an ECOG performance status of 0. Patients will be randomized into two arms - Arm A, the experimental arm, and Arm B, the reference arm - and will receive 12 cycles of mFOLFIRINOX and mFOLFOX 6 every 2 weeks, respectively. The primary endpoint of this study is the 3-year disease-free survival, and secondary endpoints include the 3-year overall survival and treatment toxicity. Discussion The Frost trial would help determine the oncologic efficacy and safety of adjuvant triplet chemotherapy for high-risk stage III colon cancers and ultimately improve prognoses. Trial registration ClinicalTrials.gov NCT05179889, registered on 17 December 2021.

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