Gastric Cancer Clinical Trial
Official title:
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
In this trial, FLOT will be evaluated as therapy option for elderly patients (>65 years) with advanced gastric cancer in comparison to the well established FLO scheme. The hypothesis is that FLOT is more effective than FLO in elderly patients with acceptable side effects.
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)
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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