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Upfront radical surgery with total mesorectal excision followed by adjuvant FOLFOX chemotherapy for locally advanced rectal cancer (TME-FOLFOX): an open-label, multicenter, phase II randomized controlled trial

DC FieldValueLanguage
dc.contributor.author정인경-
dc.contributor.author신상준-
dc.contributor.author이기쁨-
dc.contributor.author김태일-
dc.contributor.author김한상-
dc.contributor.author범승훈-
dc.contributor.author안중배-
dc.contributor.author금웅섭-
dc.contributor.author장지석-
dc.contributor.author임준석-
dc.contributor.author민병소-
dc.contributor.author이강영-
dc.contributor.author김남규-
dc.contributor.author허혁-
dc.contributor.author박소희-
dc.date.accessioned2020-09-28T02:33:58Z-
dc.date.available2020-09-28T02:33:58Z-
dc.date.issued2020-04-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/179101-
dc.description.abstractBackground: Preoperative chemoradiotherapy (PCRT) followed by surgery and adjuvant chemotherapy is the current standard treatment for stage II/III rectal cancer. However, radiotherapy in the pelvic area is commonly associated with complications such as anastomotic leakage, sexual dysfunction, and fecal incontinence. Recently, the MERCURY study showed that preoperative high-resolution magnetic resonance imaging (MRI) helped to selectively avoid PCRT. It remains unclear whether PCRT is necessary in patients who can achieve a negative circumferential resection margin (CRM) with surgery alone and in patients with cT1-2N1 or cT3N0 without CRM involvement and lateral lymph node metastasis. This study aims to evaluate the efficacy of upfront radical surgery with total mesorectal excision (TME) followed by adjuvant chemotherapy with folinic acid (or leucovorin), fluorouracil, and oxaliplatin (FOLFOX) versus the current standard treatment in patients with surgically resectable, locally advanced rectal cancer. Methods: This study, named TME-FOLFOX, is a prospective, open-label, multicenter, phase II randomized trial. Patients with locally advanced rectal cancer will be randomized to receive PCRT followed by TME and adjuvant chemotherapy (arm A) or upfront radical surgery with TME followed by adjuvant FOLFOX chemotherapy (arm B). Clinical stage II/III rectal cancer without CRM involvement and lateral lymph node metastasis will be defined using preoperative MRI. The primary endpoint is 3-year disease-free survival (DFS). Secondary endpoints include 5-year DFS, local recurrence rate, systemic recurrence rate, cost-effectiveness, and overall survival. We hypothesized that our experimental group (arm B) will have a 3-year DFS of 75% and a non-inferiority margin of 15%. Discussion: Identifying whether patients require PCRT is one of the critical issues in locally advanced rectal cancer. This study aims to elucidate whether PCRT may not be required for all patients with stage II/III rectal cancer, especially for the MRI-based intermediate-risk group (with cT1-2N1 or cT3N0) without CRM involvement and lateral lymph node metastasis. If the findings indicate that our proposed treatment, which omits PCRT, is non-inferior to the standard treatment, then patients may avoid unnecessary radiation-related toxicity, have a shorter treatment duration, and save on medical costs. Trial registration: ClinicalTrials.gov, NCT02167321. Registered on 19 June 2014.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherBioMed Central-
dc.relation.isPartOfTRIALS-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleUpfront radical surgery with total mesorectal excision followed by adjuvant FOLFOX chemotherapy for locally advanced rectal cancer (TME-FOLFOX): an open-label, multicenter, phase II randomized controlled trial-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Biomedical Systems Informatics (의생명시스템정보학교실)-
dc.contributor.googleauthorJii Bum Lee-
dc.contributor.googleauthorHan Sang Kim-
dc.contributor.googleauthorInkyung Jung-
dc.contributor.googleauthorSang Joon Shin-
dc.contributor.googleauthorSeung Hoon Beom-
dc.contributor.googleauthorJee Suk Chang-
dc.contributor.googleauthorWoong Sub Koom-
dc.contributor.googleauthorTae Il Kim-
dc.contributor.googleauthorHyuk Hur-
dc.contributor.googleauthorByung Soh Min-
dc.contributor.googleauthorNam Kyu Kim-
dc.contributor.googleauthorSohee Park-
dc.contributor.googleauthorSeung-Yong Jeong-
dc.contributor.googleauthorJeong-Heum Baek-
dc.contributor.googleauthorSeon Hahn Kim-
dc.contributor.googleauthorJoon Seok Lim-
dc.contributor.googleauthorKang Young Lee-
dc.contributor.googleauthorJoong Bae Ahn-
dc.identifier.doi10.1186/s13063-020-04266-6-
dc.contributor.localIdA03693-
dc.contributor.localIdA02105-
dc.contributor.localIdA02105-
dc.contributor.localIdA05930-
dc.contributor.localIdA05930-
dc.contributor.localIdA01079-
dc.contributor.localIdA01079-
dc.contributor.localIdA01098-
dc.contributor.localIdA01098-
dc.contributor.localIdA04581-
dc.contributor.localIdA04581-
dc.contributor.localIdA02262-
dc.contributor.localIdA02262-
dc.contributor.localIdA00273-
dc.contributor.localIdA00273-
dc.contributor.localIdA04658-
dc.contributor.localIdA04658-
dc.contributor.localIdA03408-
dc.contributor.localIdA03408-
dc.contributor.localIdA01402-
dc.contributor.localIdA01402-
dc.contributor.localIdA02640-
dc.contributor.localIdA02640-
dc.contributor.localIdA00353-
dc.contributor.localIdA00353-
dc.contributor.localIdA04373-
dc.contributor.localIdA04373-
dc.contributor.localIdA01531-
dc.contributor.localIdA01531-
dc.relation.journalcodeJ02759-
dc.identifier.eissn1745-6215-
dc.identifier.pmid32264919-
dc.subject.keywordAdjuvant chemotherapy-
dc.subject.keywordClinical trial-
dc.subject.keywordFOLFOX-
dc.subject.keywordLocally advanced rectal cancer-
dc.subject.keywordTotal mesorectal excision-
dc.contributor.alternativeNameJung, In Kyung-
dc.contributor.affiliatedAuthor정인경-
dc.contributor.affiliatedAuthor신상준-
dc.contributor.affiliatedAuthor신상준-
dc.contributor.affiliatedAuthor이기쁨-
dc.contributor.affiliatedAuthor이기쁨-
dc.contributor.affiliatedAuthor김태일-
dc.contributor.affiliatedAuthor김태일-
dc.contributor.affiliatedAuthor김한상-
dc.contributor.affiliatedAuthor김한상-
dc.contributor.affiliatedAuthor범승훈-
dc.contributor.affiliatedAuthor범승훈-
dc.contributor.affiliatedAuthor안중배-
dc.contributor.affiliatedAuthor안중배-
dc.contributor.affiliatedAuthor금웅섭-
dc.contributor.affiliatedAuthor금웅섭-
dc.contributor.affiliatedAuthor장지석-
dc.contributor.affiliatedAuthor장지석-
dc.contributor.affiliatedAuthor임준석-
dc.contributor.affiliatedAuthor임준석-
dc.contributor.affiliatedAuthor민병소-
dc.contributor.affiliatedAuthor민병소-
dc.contributor.affiliatedAuthor이강영-
dc.contributor.affiliatedAuthor이강영-
dc.contributor.affiliatedAuthor김남규-
dc.contributor.affiliatedAuthor김남규-
dc.contributor.affiliatedAuthor허혁-
dc.contributor.affiliatedAuthor허혁-
dc.contributor.affiliatedAuthor박소희-
dc.contributor.affiliatedAuthor박소희-
dc.citation.volume21-
dc.citation.number1-
dc.citation.startPage320-
dc.identifier.bibliographicCitationTRIALS, Vol.21(1) : 320, 2020-04-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Biomedical Systems Informatics (의생명시스템정보학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiation Oncology (방사선종양학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiology (영상의학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
4. Graduate School of Public Health (보건대학원) > Graduate School of Public Health (보건대학원) > 1. Journal Papers

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