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.
Investigators
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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