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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 SubIl Kim, TaeHur, HyukMin, Byung SohKim, Nam KyuPark, SoheeJeong, Seung-YongBaek, Jeong-HeumKim, Seon HahnLim, Joon SeokLee, Kang YoungAhn, Joong Bae
Issue Date
7-4월-2020
Publisher
BMC
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://scholar.korea.ac.kr/handle/2021.sw.korea/56646
DOI
10.1186/s13063-020-04266-6
ISSN
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 cT(1-2)N(1) or cT(3)N(0) 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 cT(1-2)N(1) or cT(3)N(0)) 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.
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