Trial Information

A Prospective Multicenter Study With 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) in Patients With Locally Advanced, Limited Metastatic or Extensive Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

250 patients with locally advanced or metastatic gastric carcinoma or carcinoma of the
esophagogastric junction without prior palliative therapy will be treated with 8 cycles of
the FLOT scheme (up to 12 cycles if the response is favourable). Prior to enrolment a unique
and detailed clinical evaluation of the dissemination of the disease will be done which
includes a differentiated regard of the M-category in the TNM classification. A prospective
stratification will classify the patients as having either (A) locally advanced, (B) limited
metastatic, or (C) extensive metastatic disease. In addition, the pharmacogenetic risk
profile of the patients will be evaluated by a combined analysis of two genetic
polymorphisms of the metabolism of the applied substances (XPD312, GSTT1). For the
assessment of the disease, reference regions are examined by CT or MRI scans and if
applicable endoscopy prior to the start of the study, every 2 months during and after the
end of therapy until progression of the disease occurs. Evaluation of quality of life (by
standard forms like EORTC-Q30 and others) is continued after progression. Clinical
examinations (blood count, assessment of toxicity, anamnesis) is performed every two weeks
for evaluation of toxicity and application of chemotherapy. After informed consent is given,
peripheral blood of the patient will be analysed for the pharmacogenetic risk profile.
Representative tumor material will be analysed by immunohistochemistry and quantitative PCR
for the expression of several molecular factors.