locally advanced resectable adenocarcinoma of the esophagogastreal junction or the stomach
Conditions
Interventions
Trade Name: TAXOTERE 20 mg/1 ml Konzentrat zur Herstellung
einer Infusionslösung
Product Name: not applicable
Product Code: not applicable
Sponsors
Krankenhaus Nordwest GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: locally advanced (>T1) and/or nodal positive (N+) histologically confirmed adenocarcinoma of the esophagogastreal junction (AEG I-III) or stomach without distant metastases (M0) or infiltration of adjacent structures or organs no previous resection of the tumor no previous cytostatic chemotherapy Age > 18 years (female and male). ECOG = 2 medical operability In case of a clinical suspicion of peritoneal carcinomatosis an exclusion of this diagnosis via laparoscopy is required. Leucocytes > 3.000/µl Platelets > 100.000/µl Serum creatinin = 1.5x of normal value, or Creatinin-Clearance > 40 ml/min normal ejection fraction in ECG written 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 714 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 714
Exclusion criteria
Exclusion criteria: metastases or infiltration of adjacent structures or organs and all primarily not resectable stages Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin, Epirubicin, Docetaxel and, if applicable, Capecitabine Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin, Epirubicin, Docetaxel and, if applicable, Capecitabine Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA malignant secondary disease, dated back NCI Grad II severe liver dysfunction (AST/ALT>3,5xULN, AP>6xULN, Bilirubin>1,5xULN) chronic inflammable gastro-intestinal disease inclusion in another clinical trial pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Median Overall Survival (OS); Secondary Objective: R0-Resection rate Disease-free survival Histopathological Regression Rates Evaluation of prognostic and predictive factors Perioperative morbidity and mortality Pharmacogenetic risk profile ;Primary end point(s): Overall Survival (OS);Timepoint(s) of evaluation of this end point: continuously | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): R0-Resection rate Disease-free survival Histopathological Regression Rates Evaluation of prognostic and predictive factors Perioperative morbidity and mortality Pharmacogenetic risk profile ; Timepoint(s) of evaluation of this end point: R0-Resection rate: after surgery Disease-free survival: every 3 months Histopathological Regression Rates: after surgery Perioperative morbidity and mortality: after surgery Pharmacogenetic risk profile: start of study | — |
Countries
Germany
Contacts
Public ContactIKF
Institut für Klinisch-Onkologische Forschung Krankenhaus Nordwest GmbH
Outcome results
None listed