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.
Conditions
Interventions
Product Name: Paclitaxel
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Sponsors
Klinikum rechts der Isar der Technischen Universitaet Muenchen
Eligibility
Sex/Gender
All
Inclusion 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 /= 80% - age: 18-75 years - creatinin-clearance >30 ml/min. - Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To optimize the metabolic response rate by using neoadjuvant radiochemotherapy in chemotherapy-resistent adenocarcinomas of the gastro-esophageal junction. Hypothesis: response rate >=30%;Secondary Objective: To optimize the histologic regression by using neoadjuvant radiochemotherapy in chemotherapy-resistent adenocarcinomas of the gastro-esophageal junction. ;Primary end point(s): Metabolic response rate of radiochemotherapy in chemoresistent adenocarcinomas at the esophago-gastric junction. Hypothesis > 30% | — |
Countries
Germany
Outcome results
None listed