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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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Adenocarcinomas of the Esophagogastric Junction

Thank you

Trial Information

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..


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Correlation between change in tumor metabolism (detected by PET) and histopathological response

Outcome Description:

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).

Outcome Time Frame:

PET Baseline, PET1 (before RCHT, week 5/6), histological examination of the resected tumor

Safety Issue:

No

Principal Investigator

Sylvie Lorenzen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dep. Of Medical Oncoloy, National Center for Tumor Diseases

Authority:

Germany: Federal Office for Radiation Protection

Study ID:

NCT200811021017

NCT ID:

NCT01271322

Start Date:

October 2010

Completion Date:

December 2012

Related Keywords:

  • Adenocarcinomas of the Esophagogastric Junction
  • PET
  • response evaluation
  • neoadjuvant
  • radiochemotherapy
  • adenocarcinoma of the esophagogastric junction
  • esophageal carcinoma
  • evaluation of preoperative (radio)-chemotherapy in patients with adenocarcinomas of the oesophagogastric junction
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

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