Neoadjuvant chemoradiation followed by surgery versus surgery alone for patients with adenocarcinoma or squamous cell carcinoma of the esophagus (CROSS)

作者：Mark van Heijl, JJB van Lanschot, Linetta B. Koppert, Mark I. van Berge Henegouwen, Karin Müller, Ewout W. Steyerberg, Herman van Dekken, BPL Wijnhoven, HW Tilanus, D. J. Richel, O.R. Busch, JF Bartelsman, C. C. E. Koning, G. J. A. Offerhaus, Ate van der Gaast · 发表于：BMC Surgery · 年份：2008 · DOI：10.1186/1471-2482-8-21 · 被引用次数：137 · 研究领域：Esophageal Cancer Research and Treatment、Esophageal and GI Pathology、Gastric Cancer Management and Outcomes

BACKGROUND: A surgical resection is currently the preferred treatment for esophageal cancer if the tumor is considered to be resectable without evidence of distant metastases (cT1-3 N0-1 M0). A high percentage of irradical resections is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone and in trials in which patients are treated with surgery alone. Improvement of locoregional control by using neoadjuvant chemoradiotherapy might therefore improve the prognosis in these patients. We previously reported that after neoadjuvant chemoradiotherapy with weekly administrations of Carboplatin and Paclitaxel combined with concurrent radiotherapy nearly always a complete R0-resection could be performed. The concept that this neoadjuvant chemoradiotherapy regimen improves overall survival has, however, to be proven in a randomized phase III trial. METHODS/DESIGN: The CROSS trial is a multicenter, randomized phase III, clinical trial. The study compares neoadjuvant chemoradiotherapy followed by surgery with surgery alone in patients with potentially curable esophageal cancer, with inclusion of 175 patients per arm.The objectives of the CROSS trial are to compare median survival rates and quality of life (before, during and after treatment), pathological responses, progression free survival, the number of R0 resections, treatment toxicity and costs between patients treated with neoadjuvant chemoradiotherapy followed by surgery with surgery alone for...