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 Specific Regard of Quality of Life and Pharmacogenetic Risk Profile
65 Years
N/A
Both
Gastric Cancer, Adenocarcinoma of the Esophagogastric Junction
Trial Information
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 Specific Regard of Quality of Life and Pharmacogenetic Risk Profile
Patients with locally advanced, potentially operable or metastatic gastric cancer or
adenocarcinoma of the esophagogastric junction without prior therapy in the palliative
setting are treated with:
- Arm A: FLO
- Arm B: FLOT
max. 12 cycles
Evaluation of quality of life by standard forms at baseline and then every 2 months until
progress of disease. Pharmacogenetic analyses will be done to evaluate a risk profile for
platin-based therapies. 140 patients will be treated (70 per arm)
primary endpoint:
- Response Rate
secondary endpoints:
- Prospective Validation of a pharmacogenetic risk profile for patients with advanced GC
under first-line therapy with platin/docetaxel
- Evaluation of quality of life
- safety and tolerability
- progression free survival (PFS), time to treatment failure (TTF), overall survival (OS)
Inclusion Criteria:
- metastatic or locally advanced gastric cancer or adenocarcinoma of the
esophagogastric junction
- no prior chemotherapy in metastatic state
- adequate blood and biochemistry parameters
Exclusion Criteria:
- hypersensitivity for 5-FU, Leucovorin, Oxaliplatin or Docetaxel
- KHK, cardiomyopathy or cardiac insufficiency
- malignancy <5 years ago
- brain metastases
- severe internal disease or inadequate blood and biochemistry parameters
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
response (WHO criteria)
Outcome Time Frame:
staging every 8 weeks
Safety Issue:
No
Principal Investigator
Salah Al-Batran, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Krankenhaus Nordwest
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
FLOT65+
NCT ID:
NCT00737373
Start Date:
August 2007
Completion Date:
March 2011
Related Keywords:
- Gastric Cancer
- Adenocarcinoma of the Esophagogastric Junction
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Stomach Neoplasms
- Esophageal Neoplasms
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