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

• Published in: BMC medical physics Vol. 8; no. 1; p. 3
• Main Authors: van Heijl, Mark, Omloo, Jikke M T, van Berge Henegouwen, Mark I, Busch, Olivier R C, Tilanus, Hugo W, Bossuyt, Patrick M M, Hoekstra, Otto S, Stoker, Jaap, Hulshof, Maarten C C M, van der Gaast, Ate, Nieuwenhuijzen, Grard A P, Bonenkamp, Han J, Plukker, John Th M, Bilgen, Ernst J Spillenaar, Ten Kate, Fibo J W, Boellaard, Ronald, Pruim, Jan, Sloof, Gerrit W, van Lanschot, J Jan B
• Format: Journal Article
• Language: English
• Published: England BioMed Central 31.07.2008
• Subjects: Study Protocol
• ISSN: 1756-6649; 1756-6649
• DOI: 10.1186/1756-6649-8-3

Surgical resection is the preferred treatment of potentially curable esophageal cancer. To improve long term patient outcome, many institutes apply neoadjuvant chemoradiotherapy. In a large proportion of patients no response to chemoradiotherapy is achieved. These patients suffer from toxic and ineffective neoadjuvant treatment, while appropriate surgical therapy is delayed. For this reason a diagnostic test that allows for accurate prediction of tumor response early during chemoradiotherapy is of crucial importance. CT-scan and endoscopic ultrasound have limited accuracy in predicting histopathologic tumor response. Data suggest that metabolic changes in tumor tissue as measured by FDG-PET predict response better. This study aims to compare FDG-PET and CT-scan for the early prediction of non-response to preoperative chemoradiotherapy in patients with potentially curable esophageal cancer. 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. ISRCTN45750457.