Evidence map›Paper›PMID 38553680›Full record

ArticleBMC cancer2024

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 and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05179889 (mFOLFIRINOX Versus mFOLFOX 6 as Adjuvant Treatment for High Risk Stage III), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05179889 phase2 / phase3recruitingnot on this map

mFOLFIRINOX Versus mFOLFOX 6 as Adjuvant Treatment for High Risk Stage III (pT4N1/2 or pTanyN2) Colon Cancer: Multicenter, Open Labeled, Randomized, Phase II Study

TypeinterventionalSponsorChungnam National University HospitalRan2021 to 2031Enrolled308ConditionsColon Cancer Stage IIIArmsmFOLFIRINOX, mFOLFOX 6
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Personalizing Perioperative Chemotherapy in Colon Cancer.Clinics in colon and rectal surgery · 2025
    Review
  3. Article
  4. Entering the Era of Multidimensional Prognostication for Personalized Risk Assessment in Stage III Colon Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 7 institutions in 1 country.

Kyung-Ha LeeDepartment of Colorectal Surgery, Chungnam National University Hospital & College of Medicine, Daejeon, Korea.
In Jun YangDepartment of Colorectal Surgery, Chungnam National University Hospital & College of Medicine, Daejeon, Korea.
Gi Won HaBiomedical Research Institute, Jeonbuk National University Hospital, Jeonju, Korea.
Jaeim LeeDepartment of Surgery, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Korea.
Youn Young ParkDepartment of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, Korea.
Suk Hwan LeeDepartment of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, Korea.
Jong Min LeeDepartment of Surgery, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Korea.
Jung Hoon BaeDepartment of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Eun Jung ParkDivision of Colorectal Surgery, Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Hyungjin KimDepartment of Surgery, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Keun Young KimDepartment of General Surgery, Wonkwang University Hospital & School of Medicine, Iksan, Korea.
Sanghyung AnDepartment of Surgery, Yonsei University, Wonju College of Medicine, Wonju, Korea.
Ik Yong KimDepartment of Surgery, Yonsei University, Wonju College of Medicine, Wonju, Korea.
Ji Yeon KimDepartment of Colorectal Surgery, Chungnam National University Hospital & College of Medicine, Daejeon, Korea. jkim@cnu.ac.kr.
Chungnam National University Hospital · KRYonsei University · KRKyung Hee University Hospital at Gangdong · KRThe Catholic University of Korea Seoul St. Mary's Hospital · KRThe Catholic University of Korea Uijeongbu St. Mary's Hospital · KRJeonbuk National University · KRWonkwang University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHigh-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.

methodsThis 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 registrationClinicalTrials.gov NCT05179889, registered on 17 December 2021.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsColonic NeoplasmsAdultAgedChemotherapy, AdjuvantClinical Trials, Phase II as TopicDisease-Free SurvivalFluorouracilHumansMiddle AgedMulticenter Studies as TopicProgression-Free SurvivalRandomized Controlled Trials as TopicYoung AdultFluorouracilAdjuvant chemotherapyEfficacyHigh-risk stage III colon cancermFOLFIRINOXmFOLFOX 6PrognosisToxicity

Identifiers

PMID38553680
PMCPMC10979582
OpenAlexW4393311711

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.