NEOadjuvant therapy monitoring with PET and CT in Esophageal Cancer (NEOPEC-trial)

Prognostic accuracy study, embedded in a randomized multicenter Dutch trial comparing neoadjuvant chemoradiotherapy for 5 weeks followed by surgery versus surgery alone for esophageal cancer. This prognostic accuracy study is performed only in the neoadjuvant arm of the randomized trial. In 6 centers, 150 consecutive patients will be included over a 3 year period. FDG-PET and CT-scan will be performed before and 2 weeks after the start of the chemoradiotherapy. All patients complete the 5 weeks regimen of neoadjuvant chemoradiotherapy, regardless the test results. Pathological examination of the surgical resection specimen will be used as reference standard. Responders are defined as patients with < 10% viable residual tumor cells (Mandard-score).Difference in accuracy (area under ROC curve) and negative predictive value between FDG-PET and CT-scan are primary endpoints. Furthermore, an economic evaluation will be performed, comparing survival and costs associated with the use of FDG-PET (or CT-scan) to predict tumor response with survival and costs of neoadjuvant chemoradiotherapy without prediction of response (reference strategy).The NEOPEC-trial could be the first sufficiently powered study that helps justify implementation of FDG-PET for response-monitoring in patients with esophageal cancer in clinical practice.ISRCTN45750457Worldwide, esophageal cancer is sixth on the list of cancer related mortality causes. In the Western world the total incidence of esophageal cancer is rising, mainly as the result of a six fold increase in the incidence of adenocarcinoma over the last decades. [1] In the Netherlands approximately 1,500 new patients are annually diagnosed with esophageal cancer.Surgical resection is currently the preferred curative treatment for esophageal cancer. In the Netherlands 300 – 400 patients per year are candidates for surgery with curative intent. [2] Even if esophageal cancer resection is only performed with curative intent, in approximately 30%