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Clinical Trials/EUCTR2011-001856-12-CZ
EUCTR2011-001856-12-CZ
Active, not recruiting
Phase 1

Early assessment of effectivness of neoadjuvant chemotherapy for carcinoma of the esophagus and esophago-gastric junction using FDG-PET/CT.

The Motol University Hospital0 sitesJuly 26, 2011

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
The Motol University Hospital
Status
Active, not recruiting
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 26, 2011
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
The Motol University Hospital

Eligibility Criteria

Inclusion Criteria

  • age 18\-75 years, males and females
  • histologically verified adenocarcinoma of the esophagus or esophago\-gastric junction or proximal stomach affecting cardia
  • no distant metastases or non\-regional lymph node metastasis on computed tomography of chest and abdomen
  • cT1, N1, M0\-1a or cT2\-T4 (potentially resectable tumor), N0\-1, M0\-1a (TNM staging AJCC 6th edition) on EUS and CT
  • performance status 0\-1 (WHO)
  • medically fit for elective esophagectomy after neoadjuvant chemotherapy
  • signed informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • Patients with insulin\-dependent diabetes mellitus or DM II on oral antidiabetics with glycemia level above 10 mmol/l
  • Patients with the finding of distant organ metastases at the inicial FDG\-PET/CT will be excluded from the study
  • pregnant or nursing women

Outcomes

Primary Outcomes

Not specified

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