Adenocarcinomas of the Esophagogastric Junction Clinical Trial
Official title:
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
Prospective, single-center, nonrandomized, explorative imaging study evaluating the value of
PET as a predictor of histopathological response in metabolic non-responders Patients with
resectable AEG (adenocarcinoma of the esophagogastric junction) type I and II (cT3/4 and/or
cN+ and cM0)
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 (radiochemotherapy) 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.
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.. ;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment