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Open Access Study protocol

Sequential FDG-PET and induction chemotherapy in locally advanced adenocarcinoma of the Oesophago-gastric junction (AEG): The Heidelberg Imaging program in Cancer of the oesophago-gastric junction during Neoadjuvant treatment: HICON trial

Sylvie Lorenzen1*, Carl von Gall2, Annika Stange1, Georg M Haag1, Jürgen Weitz3, Uwe Haberkorn2, Florian Lordick4, Wilko Weichert5, Ulrich Abel6, Jürgen Debus7, Dirk Jäger1 and Marc W Münter7

Author Affiliations

1 National Center for Tumor Diseases (NCT), University of Heidelberg, Germany

2 Department of Nuclear Medicine, University of Heidelberg, Germany

3 Department of Surgery, University Hospital of Heidelberg, Germany

4 Medizinische Klinik III, Klinikum Braunschweig, Germany

5 Institute of Pathology, University of Heidelberg, Germany

6 Department of Medical Biometry, University of Heidelberg, Germany

7 Department of Radiation Oncology, University of Heidelberg, Germany

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BMC Cancer 2011, 11:266  doi:10.1186/1471-2407-11-266

Published: 24 June 2011

Abstract

Background

18-Fluorodeoxyglucose-PET (18F-FDG-PET) can be used for early response assessment in patients with locally advanced adenocarcinomas of the oesophagogastric junction (AEG) undergoing neoadjuvant chemotherapy. It has been recently shown in the MUNICON trials that response-guided treatment algorithms based on early changes of the FDG tumor uptake detected by PET are feasible and that they can be implemented into clinical practice.

Only 40%-50% of the patients respond metabolically to therapy. As metabolic non-response is known to be associated with a dismal prognosis, metabolic non-responders are increasingly treated with alternative neoadjuvant chemotherapies or chemoradiation in order to improve their clinical outcome. We plan to investigate whether PET can be used as response assessment during radiochemotherapy given as salvage treatment in early metabolic non-responders to standard chemotherapy.

Methods/Design

The HICON trial is a prospective, non-randomized, explorative imaging study evaluating the value of PET as a predictor of histopathological response in metabolic non-responders. Patients with resectable AEG type I and II according to Siewerts classification, staged cT3/4 and/or cN+ and cM0 by endoscopic ultrasound, spiral CT or MRI and FDG-PET are eligible. Tumors must be potentially R0 resectable and must have a sufficient FDG-baseline uptake. Only metabolic non-responders, showing a < 35% decrease of SUV two weeks after the start of neoadjuvant chemotherapy are eligible for the study and are taken to intensified taxane-based RCT (chemoradiotherapy (45 Gy) before surgery. 18FDG-PET scans will be performed before ( = Baseline) and after 14 days of standard neoadjuvant therapy as well as after the first cycle of salvage docetaxel/cisplatin chemotherapy (PET 1) and at the end of radiochemotherapy (PET2). Tracer uptake will be assessed semiquantitatively using standardized uptake values (SUV). The percentage difference ΔSUV = 100 (SUVBaseline - SUV PET1)/SUVBaseline will be calculated and assessed as an early predictor of histopathological response. In a secondary analysis, the association between the difference SUVPET1 - SUVPET2 and histopathological response will be evaluated.

Discussion

The aim of this study is to investigate the potential of sequential 18FDG-PET in predicting histopathological response in AEG tumors to salvage neoadjuvant radiochemotherapy in patients who do not show metabolic response to standard neoadjuvant chemotherapy.

Trial Registration

Clinical trial identifier NCT01271322