Assessment of response to neoadjuvant chemotherapy early in the course of treatment in cancer of the esophagus and the junction of esophagus and stomach
- Conditions
- adenocarcinoma of the esophagus and esophago-gastric junctionTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001856-12-CZ
- Lead Sponsor
- The Motol University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method