A multicenter, randomised phase II trial on the therapy of advanced gastric cancer or adenocarcinoma of the esophagogastric junction in patients older than 65 years with special regard on quality of life and the pharmacogenetic risk profile - FLOT65+
- Conditions
- metastatic or locally advanced gastric cancer or adenocarcinoma of the esophagogastric junction
- Registration Number
- EUCTR2006-006936-24-DE
- Lead Sponsor
- Krankenhaus Nordwest GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 108
metastatic, locally advanced or refractory gastric cancer or adenocarcinoma of the esophagogastric junction
no previous chemotherapy in metastatic state
patients (male and female) older than 65 years
ECOG 0, 1 or 2
Leucocytes > 3000/µl
Thrombocytes >100000/µl
Creatinine serum level < 1,5x ULN or Creatinine clearance > 40 ml/min
signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Hypersensitivity for 5-Fluorouracil, Leucovorin, Oxaliplatin or Docetaxel
KHK, cardiomyopathy or cardiac insufficiency II-IV (NYHA)
second malignancy <5years ago
brain metastases
severe internal dysfunction or acute infection
peripheral polyneuropathie >NCI grade II
impairment of liver function (AST/AKT>3,5xULN, AP>6xULN, Bilirubin>1,5xULN)
chronic intestinal inflammation
participation in another clinical trial
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