EUCTR2005-004123-19-DE
Active, not recruiting
Not 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 sitesNovember 2, 2005
ConditionsThis study will test an optimized therapy for patients with chemotherapy-resistent locally advanced adenocarcinomas at the gastro-esophageal junction.According to the protocol, patients should receive a neoadjuvant radiochemotherapy if the tumor is metabolically not responding to chemotherapy.Therapeutic area: Body processes [G] - Physical Phenomena [G01]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- This study will test an optimized therapy for patients with chemotherapy-resistent locally advanced adenocarcinomas at the gastro-esophageal junction.According to the protocol, patients should receive a neoadjuvant radiochemotherapy if the tumor is metabolically not responding to chemotherapy.
- Sponsor
- Klinikum rechts der Isar der Technischen Universitaet Muenchen
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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