• Xiaobin Zhang, Ben M Eyck, Yang Yang, Jun Liu, Yin-Kai Chao, Ming-Mo Hou, Tsung-Min Hung, Qingsong Pang, Zhen-Tao Yu, Hongjing Jiang, Simon Law, Ian Wong, Ka-On Lam, Berend J van der Wilk, Ate van der Gaast, SpaanderManon C WMCWDepartment of Gastroenterology and Hepatology, Erasmus MC - University Medical Center, Dr. Molewaterplein 40, Rotterdam, the Netherlands., Roelf Valkema, Sjoerd M Lagarde, WijnhovenBas P LBPLDepartment of Surgery, Erasmus MC - University Medical Center, Dr. Molewaterplein 40, Rotterdam, the Netherlands., van LanschotJ Jan BJJBDepartment of Surgery, Erasmus MC - University Medical Center, Dr. Molewaterplein 40, Rotterdam, the Netherlands., and Zhigang Li.
• Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, 241 West Huaihai Road, Shanghai, 200030, China.
• Bmc Cancer. 2020 Mar 6; 20 (1): 194.

BackgroundAfter neoadjuvant chemoradiotherapy (nCRT) for esophageal cancer, high pathologically complete response (pCR) rates are being achieved especially in patients with squamous cell carcinoma (SCC). An active surveillance strategy has been proposed for SCC patients with clinically complete response (cCR) after nCRT. To justify omitting surgical resection, patients with residual disease should be accurately identified. The aim of this study is to assess the accuracy of response evaluations after nCRT based on the preSANO trial, including positron emission tomography with computed tomography (PET-CT), endoscopy with bite-on-bite biopsies and endoscopic ultrasonography (EUS) with fine-needle aspiration (FNA) in patients with potentially curable esophageal SCC.MethodsOperable esophageal SCC patients who are planned to undergo nCRT according to the CROSS regimen and are planned to undergo surgery will be recruited from four Asian centers. Four to 6 weeks after completion of nCRT, patients will undergo a first clinical response evaluation (CRE-1) consisting of endoscopy with bite-on-bite biopsies. In patients without histological evidence of residual tumor (i.e. without positive biopsies), surgery will be postponed another 6 weeks. A second clinical response evaluation (CRE-2) will be performed 10-12 weeks after completion of nCRT, consisting of PET-CT, endoscopy with bite-on-bite biopsies and EUS with FNA. Immediately after CRE-2 all patients without evidence of distant metastases will undergo esophagectomy. Results of CRE-1 and CRE-2 as well as results of the three single diagnostic modalities will be correlated to pathological response in the resection specimen (gold standard) for calculation of sensitivity, specificity, negative predictive value and positive predictive value.DiscussionIf the current study shows that major locoregional residual disease (> 10% residual carcinoma or any residual nodal disease) can be accurately (i.e. with sensitivity of 80.5%) detected in patients with esophageal SCC, a prospective trial will be conducted comparing active surveillance with standard esophagectomy in patients with a clinically complete response after nCRT (SINO trial).Trial RegistrationThe preSINO trial has been registered at ClinicalTrials.gov as NCT03937362 (May 3, 2019).

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