Accuracy of Detecting Residual Disease After Cross Neoadjuvant Chemoradiotherapy for Esophageal Cancer (preSANO Trial): Rationale and Protocol.

摘要: Background: Results from the recent CROSS trial showed that neoadjuvant chemoradiotherapy (nCRT) significantly increased survival as compared to surgery alone in patients with potentially curable esophageal cancer. Furthermore, nCRT arm 49% of a squamous cell carcinoma (SCC) and 23% an adenocarcinoma (AC) had pathologically complete response resection specimen. These results provide rationale reconsider study timing necessity esophagectomy (all) after application regimen. Objective: We propose “surgery needed” approach completion nCRT. In this approach, will undergo active surveillance Surgical would be offered only those whom residual disease or locoregional recurrence is highly suspected proven. However, before needed oesophageal cancer (SANO) can tested randomized controlled trial, we aim determine accuracy detecting presence absence (preSANO trial). Methods: This set up prospective, single arm, multicenter, diagnostic trial. Operable SCC AC esophagus esophagogastric junction included. Approximately 4-6 weeks all included first clinical evaluation (CRE-I) including endoscopy (random) conventional mucosal biopsies primary tumor site any other lesions radial endo-ultrasonography (EUS) for measurement thickness area. Patients no disseminated proven by cytohistology postponed surgical 6-8 CRE-I (ie, approximately 12-14 nCRT). week preceding resection, second (CRE-II) planned include whole body PET-CT, followed again esophagus, EUS area, linear plus fine needle aspiration PET-positive and/or lymph nodes. The main parameter correlation between assessment during CRE-II final pathological Results: patient was enrolled on July 23, 2013, are expected January 2016. Conclusions: If preSANO shows predicted reliably 6 12 nCRT, comparing standard versus conducted (SANO Trial Registration: Netherlands Register: NTR4834; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4834 (archived Webcite at http://www.webcitation.org/6Ze7mn67B). [JMIR Res Protoc 2015;4(2):e79]