EUCTR2005-004123-19-DEActive, not recruitingNot Applicable
Metabolic Response Evaluation for an Individualization of Neoadjuvant Chemo- and Radiotherapy in Esophageal Adenocarcinoma - MUNICON-2
Klinikum rechts der Isar der Technischen Universitaet Muenchen0 sitesStarted: November 2, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- histologically verified adenocarcinoma at the gastro-esophageal junction
- •- potentially R0 resectable. Primary tumor category cT3 and cT4
- •- medically operable patient: risk-score <22 (Bartels)
- •- intensive FDG-tracerenhancement of the tumor (for follow-up)
- •- performance-status 0-1 (ECOG); i.e. Karnofsky-index >/= 80%
- •- age: 18-75 years
- •- creatinin-clearance >30 ml/min.
- •- Bilirubin <1,5 mg/dl
- •- negative pregnancy test (women)
- •- signed consent form
- •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 46
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
- •- remote metastasis (M1b)
- •- tumor infiltration into the tracheo-bronchial system
- •- previous chemotherapy and/or radiotherapy of the chest
- •- uncontrolled infectious disease
- •- polyneuropathy >I°
- •- heart failure (> NYHA I)
- •- pre-operativ risk-score >22 (Bartels)
- •- uncontrolled diabetes mellitus
- •- pregnancy or breast-feeding woman
Investigators
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