2020
DOI: 10.1186/s13063-020-04266-6
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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

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 … Show more

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Cited by 7 publications
(5 citation statements)
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References 30 publications
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“…The results demonstrated that SSIM and FOM of INLM were both obviously higher than those of FBP algorithm and NLM algorithm, while the average running time of INLM algorithm was less than that of FBP and NLM algorithm. The differences between the indexes of three algorithms had statistical significance ( P < 0.05), which was similar to the results of the analysis of image reconstruction algorithm conducted by Lee et al [ 23 ]. The similarity of these results demonstrated that the proposed INLM algorithm could improve the accuracy of image reconstruction by traditional algorithm, shorten running time, and enhance overall diagnostic efficiency.…”
Section: Discussionsupporting
confidence: 87%
See 1 more Smart Citation
“…The results demonstrated that SSIM and FOM of INLM were both obviously higher than those of FBP algorithm and NLM algorithm, while the average running time of INLM algorithm was less than that of FBP and NLM algorithm. The differences between the indexes of three algorithms had statistical significance ( P < 0.05), which was similar to the results of the analysis of image reconstruction algorithm conducted by Lee et al [ 23 ]. The similarity of these results demonstrated that the proposed INLM algorithm could improve the accuracy of image reconstruction by traditional algorithm, shorten running time, and enhance overall diagnostic efficiency.…”
Section: Discussionsupporting
confidence: 87%
“…e differences between the indexes of three algorithms had statistical significance (P < 0.05), which was similar to the results of the analysis of image reconstruction algorithm conducted by Lee et al [23]. e similarity of these results demonstrated that the proposed INLM algorithm could improve the accuracy of image reconstruction by traditional algorithm, shorten running time, and enhance overall diagnostic efficiency.…”
Section: Discussionsupporting
confidence: 84%
“…The phase II TME-FOLFOX study aims to evaluate the efficacy of upfront radical surgery with TME followed by adjuvant chemotherapy with folinic acid (or leucovorin), 5-FU, and oxaliplatin (FOLFOX) versus the current standard treatment in patients with surgically resectable LARC. The study investigates whether patients with cT 1-2 N 1 or cT 3 N 0 without circumferential resection margin (CRM) involvement and lateral lymph node metastasis as evaluated on preoperative high-resolution magnetic resonance imaging (MRI) may not require preoperative CRT [ 47 ]. If in resectable mid/low LARC, omission of CRT is non-inferior to the standard treatment; radiation-related toxicity could be avoided.…”
Section: Introductionmentioning
confidence: 99%
“…In conclusion, omitting PRCT and treatment with upfront surgery alone in CRM negative rectal cancer stage II/III patients may be considered as future treatment options. To further validate our retrospective results, a phase 2, randomized controlled trial of upfront surgery versus PRCT followed by surgery is currently ongoing (ClinicalTrials.gov, NCT02167321) ( 35 ).…”
Section: Discussionmentioning
confidence: 96%