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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

Authors
 Jii Bum Lee  ;  Han Sang Kim  ;  Inkyung Jung  ;  Sang Joon Shin  ;  Seung Hoon Beom  ;  Jee Suk Chang  ;  Woong Sub Koom  ;  Tae Il Kim  ;  Hyuk Hur  ;  Byung Soh Min  ;  Nam Kyu Kim  ;  Sohee Park  ;  Seung-Yong Jeong  ;  Jeong-Heum Baek  ;  Seon Hahn Kim  ;  Joon Seok Lim  ;  Kang Young Lee  ;  Joong Bae Ahn 
Citation
 TRIALS, Vol.21(1) : 320, 2020-04 
Journal Title
 TRIALS 
Issue Date
2020-04
Keywords
Adjuvant chemotherapy ; Clinical trial ; FOLFOX ; Locally advanced rectal cancer ; Total mesorectal excision
Abstract
Background: 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.
Files in This Item:
T202001888.pdf Download
DOI
10.1186/s13063-020-04266-6
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
Yonsei Authors
Koom, Woong Sub(금웅섭) ORCID logo https://orcid.org/0000-0002-9435-7750
Kim, Nam Kyu(김남규) ORCID logo https://orcid.org/0000-0003-0639-5632
Kim, Tae Il(김태일) ORCID logo https://orcid.org/0000-0003-4807-890X
Kim, Han Sang(김한상) ORCID logo https://orcid.org/0000-0002-6504-9927
Min, Byung Soh(민병소) ORCID logo https://orcid.org/0000-0003-0180-8565
Park, So Hee(박소희) ORCID logo https://orcid.org/0000-0001-8513-5163
Beom, Seung Hoon(범승훈) ORCID logo https://orcid.org/0000-0001-7036-3753
Shin, Sang Joon(신상준) ORCID logo https://orcid.org/0000-0001-5350-7241
Ahn, Joong Bae(안중배) ORCID logo https://orcid.org/0000-0001-6787-1503
Lee, Kang Young(이강영)
Lee, Jii Bum(이기쁨)
Lim, Joon Seok(임준석) ORCID logo https://orcid.org/0000-0002-0334-5042
Chang, Jee Suk(장지석) ORCID logo https://orcid.org/0000-0001-7685-3382
Jung, Inkyung(정인경) ORCID logo https://orcid.org/0000-0003-3780-3213
Hur, Hyuk(허혁) ORCID logo https://orcid.org/0000-0002-9864-7229
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/179101
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