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Cited 4 time in webofscience Cited 6 time in scopus
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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
Lee, Jii BumKim, Han SangJung, InkyungShin, Sang JoonBeom, Seung HoonChang, Jee SukKoom, Woong SubKim, Il TaeHur, HyukMin, Byung SohKim, Nam KyuPark, SoheeJeong, Seung-YongBaek, Jeong-HeumKim, Seon HahnLim, Joon SeokLee, Kang YoungAhn, Joong Bae
Issue Date
Apr-2020
Publisher
BioMed Central
Keywords
Adjuvant chemotherapy; Clinical trial; FOLFOX; Locally advanced rectal cancer; Total mesorectal excision
Citation
Trials, v.21, no.1
Indexed
SCIE
SCOPUS
Journal Title
Trials
Volume
21
Number
1
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/867
DOI
10.1186/s13063-020-04266-6
ISSN
1745-6215
1745-6215
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.
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2. Clinical Science > Department of Colon and Rectal Surgery > 1. Journal Articles

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