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
Affiliations
Kyung-Ha Lee
Department of Colorectal Surgery, Chungnam National University Hospital & College of Medicine
In Jun Yang
Department of Colorectal Surgery, Chungnam National University Hospital & College of Medicine
Gi Won Ha
Biomedical Research Institute, Jeonbuk National University Hospital
Jaeim Lee
Department of Surgery, Uijeongbu St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Youn Young Park
Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine
Suk Hwan Lee
Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine
Jong Min Lee
Department of Surgery, Yongin Severance Hospital, Yonsei University College of Medicine
Jung Hoon Bae
Department of Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Eun Jung Park
Division of Colorectal Surgery, Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine
Hyungjin Kim
Department of Surgery, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Keun Young Kim
Department of General Surgery, Wonkwang University Hospital & School of Medicine
Sanghyung An
Department of Surgery, Yonsei University, Wonju College of Medicine
Ik Yong Kim
Department of Surgery, Yonsei University, Wonju College of Medicine
Ji Yeon Kim
Department of Colorectal Surgery, Chungnam National University Hospital & College of Medicine
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.
