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Open Access Highly Accessed Study protocol

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

Mark van Heijl1*, Jikke MT Omloo1, Mark I van Berge Henegouwen1, Olivier RC Busch1, Hugo W Tilanus2, Patrick MM Bossuyt3, Otto S Hoekstra4, Jaap Stoker5, Maarten CCM Hulshof6, Ate van der Gaast7, Grard AP Nieuwenhuijzen8, Han J Bonenkamp9, John ThM Plukker10, Ernst J Spillenaar Bilgen11, Fibo JW ten Kate12, Ronald Boellaard13, Jan Pruim14, Gerrit W Sloof15 and J Jan B van Lanschot12

Author Affiliations

1 Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands

2 Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands

3 Department of Clinical Epidiomiology, Biostatistics and Bioinformatics, Academic Medical Center, Amsterdam, The Netherlands

4 Department of Nuclear Medicine, VU Medical Center, Amsterdam, The Netherlands

5 Department of Radiology, Academic Medical Center, Amsterdam, The Netherlands

6 Department of Radiotherapy, Academic Medical Center, Amsterdam, The Netherlands

7 Department of Medical Oncology, Erasmus Medical Center, Rotterdam, The Netherlands

8 Department of Surgery, Catharina Hospital Eindhoven, Eindhoven, The Netherlands

9 Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands

10 Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands

11 Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands

12 Department of Pathology, Academic Medical Center, Amsterdam, The Netherlands

13 Department of Nuclear Medicine and PET research, VU Medical Center, Amsterdam, The Netherlands

14 Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

15 Department of Nuclear Medicine, Academic Medical Center, Amsterdam, The Netherlands

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BMC Medical Physics 2008, 8:3  doi:10.1186/1756-6649-8-3

Published: 31 July 2008

Abstract

Background

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.

Methods/design

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).

Discussion

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.

Trial registration

ISRCTN45750457