Adenocarcinomas of the Esophagogastric Junction Clinical Trial
— HICONOfficial 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.
| Status | Terminated |
| Enrollment | 0 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Biopsy-proven adenocarcinoma of the distal oesophagus (AEG type I) or cardia (AEG type II) with or without metastases in local lymph nodes (tumor stage cT3/T4, cNX, and cM0 in the tumor-node-metastasis classification) - Staging procedures include endoscopy, endoscopic ultrasound and computed tomography (CT) of the chest and abdomen. - Eligible patients have to be fit for platin-containing chemotherapy - Tumors must be potentially R0 resectable tumors during consecutive operation. - Tumors must have demonstrated a minimal amount of FDG-uptake in the baseline PET-CT, defined as 18FDG-uptake in tumor at first examination > 1,35 x hepatic-SUV + 2 x standard-deviation of hepatic-SUV, and must be a metabolic non-responder under EOX, defined as a decrease of the SUVmax of <35% in a second PET on day 14 of chemotherapy. Exclusion Criteria: - Eastern Cooperative Oncology Group score >1 - Previous or secondary malignancy - Life expectancy of less than 3 months - Uncontrolled bleeding from the tumor - Tumor infiltration of the airways - Pregnancy - Uncontrolled diabetes - Patients are also ineligible if they have undergone previous chemotherapy, radiotherapy, or endoscopic laser therapy. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Nationales Centrum für Tumorerkrankungen | Heidelberg |
| Lead Sponsor | Collaborator |
|---|---|
| National Center for Tumor Diseases, Heidelberg |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
| Secondary | distribution of change in tumor metabolism during the treatment in histological responders and non-responders | investigation of the distribution of change in tumor metabolism measured with PET Baseline and PET1(?SUV = 100 (SUVBaseline - SUVPET1) / SUVBaseline) during the treatment in histological responders and non-responders according to the Becker Score (Histomorphology and grading of regression) | PET Baseline, PET1 (week 5/6), histological examination of the resected tumor | No |
| Secondary | accuracy of the binary prediction rule reduction in the tumor metabolism >65% vs. <65% in histopathological responders vs. non-responders | accuracy of the binary prediction rule delta SUV >65% vs. <65% (reduction in the tumor metabolism >65% vs. <65 % between PET Baseline and PET1 in correlation with the histopathological regression accoring to the Becker Score | Baseline, PET1 (week 5/6), histological examination of the resected tumor | No |
| Secondary | association between change in tumor metabolism before/after radiochemotherapy and histopathological response | association between tumor metabolism before/after radiochemotherapy (?SUV = 100 (SUVPET1 - SUVPET2) / SUVPET1) and histopathological response according to the Becker Score (histomorphology and grading of regression) | PET1 (week 5/6), PET2 (before resection), histological examination of the resected tumor | No |
| Secondary | association between change in tumor metabolism between PET Baseline and PET1 and overall survival as well as disease-free survival | association between change in tumor metabolism between PET Baseline and PET 1 (?SUV = 100 (SUVBaseline - SUVPET1) / SUVBaseline)and overall survival as well as disease-free survival | Baseline, PET1 (week 5/6), Follow Up (q3 months during the first post-operative year, q6 months during the 2nd/3rd postoperative year) | No |