TY - JOUR T1 - Dragon III- Phase II Randomized Controlled Trial: Neoadjuvant FLOT versus SOX for Patients with Locally Advanced Gastric Cancer JF - medRxiv DO - 10.1101/2020.06.21.20136887 SP - 2020.06.21.20136887 AU - Sah, Birendra Kumar AU - Zhang, Benyan AU - Zhang, Huan AU - Li, Jian AU - Yuan, Fei AU - Ma, Tao AU - Shi, Min AU - Xu, Wei AU - Zhu, Zhenglun AU - Liu, Wentao AU - Yan, Chao AU - Li, Chen AU - Liu, Bingya AU - Yan, Min AU - Zhu, Zhenggang Y1 - 2020/01/01 UR - http://medrxiv.org/content/early/2020/08/05/2020.06.21.20136887.abstract N2 - Background Neoadjuvant chemotherapy with docetaxel, oxaliplatin, fluorouracil, and leucovorin (the FLOT regimen) has shown promising results in terms of pathological response and survival rate. However, tegafur gimeracil oteracil potassium capsule (S-1) plus oxaliplatin (the SOX regimen) is a more favorable chemotherapy regimen in Eastern countries. We conducted this study to evaluate the safety and efficacy of both regimens and to explore a suitable regimen for gastric cancer patients.Methods Patients with locally advanced gastric cancer (LAGC) were 1:1 randomly assigned to receive either 4 cycles of the FLOT regimen or 3 cycles of the SOX regimen before curative gastrectomy. The primary endpoint was the comparison of complete or subtotal tumor regression grading (TRG1a+ TRG1b) in the primary tumor.Results Altogether, 74 patients were enrolled between August 2018 and March 2020. There was no significant difference in pretreatment clinicopathological parameters between the FLOT group and the SOX group (p&gt;0.05). There was no significant difference in adverse effects or postoperative morbidity and mortality between the two groups (p&gt;0.05). Similarly, there was no significant difference in the proportion of tumor regression grading between the FLOT group and the SOX group (p&gt;0.05). In the ITT population, complete or subtotal TRG was 20.0% in the FLOT group versus 32.4% in the SOX group (p&gt;0.05).Conclusion Our study demonstrates that the FLOT and SOX regimens are similarly effective for locally advanced gastric cancer patients in terms of clinical downstaging and pathological response. A large-scale phase III randomized controlled trial is necessary to validate this result.Competing Interest StatementThe authors have declared no competing interest.Clinical TrialClinicalTrials.gov, number NCT03636893Funding StatementThe overall costs of publication will be funded by grants from the National Natural Science Foundation of China (No. 91529302 (BY Liu), No.81772509 (Liu BY), and No. 81871904 (Zhu ZG)Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:institutional review board (IRB), Ruijin HospitalAll necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesAny data regarding this study are kept safe with corresponding authors and can be obtained for reasonable request. ER -