Sequential FDG-PET (Positron Emission Tomography) and Induction Chemotherapy in Locally Advanced Adenocarcinoma of the Esophagogastric Junction (AEG): The Heidelberg Imaging Program in Cancer of the Oesophago-gastric Junction During Neoadjuvant Treatment: HICON Trial
The HICON trial is a prospective, single-center, nonrandomized, explorative imaging study
evaluating the value of PET (Positron emission tomography) as a predictor of
histopathological response in metabolic non-responders Patients with resectable AEG
(adenocarcinoma of the esophagogastric junction) type I and II, 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 (standardized uptake value) 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
after the first cycle of Taxotere/Cisplatin chemotherapy (=PET1) and at the end of
intensified radiochemotherapy (PET2). Tracer uptake will be assessed semiquantitatively
using standardized uptake values (SUV). The percentage difference Delta
SUV=100(SUVBaseline-SUVPET1)/ 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..
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Correlation between change in tumor metabolism (detected by PET) and histopathological response
The primary objective of the study is to evaluate the change in metabolic response - as measured by the relative difference delta SUV=100(SUVBaseline-SUVPET1)/ SUVBaseline in 18F-FDG uptake after 1 cycle of intensified taxan-based chemotherapy (PET1) - relative to the 18F-FDG uptake at the baseline examination, as a predictor of histopathological response in metabolic non-responders (assessed by PET 14 days after the start of neoadjuvant therapy).
PET Baseline, PET1 (before RCHT, week 5/6), histological examination of the resected tumor
No
Sylvie Lorenzen, MD
Principal Investigator
Dep. Of Medical Oncoloy, National Center for Tumor Diseases
Germany: Federal Office for Radiation Protection
NCT200811021017
NCT01271322
October 2010
December 2012
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