5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced, Resectable Gastric Cancer

Launched by KRANKENHAUS NORDWEST · Oct 6, 2010

Keywords

ClinConnect Summary

714 Patients with locally advanced resectable (T2-4 and/or N+, M0) adenocarcinoma of the stomach or the esophagogastreal junction without previous therapy will be included in this study. After randomization patients receive perioperatively 4 cycles FLOT or 3 cycles ECF, followed by a restaging of the tumour status and surgery. Subsequently another 4 cycles of FLOT or 3 cycles ECF are applicated. Then a central validation of the pathological remission rate is scheduled. Primary endpoint is overall survival, secondary endpoints are disease free survival, perioperative morbidity and mortality,...

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Eligibility criteria

• Inclusion Criteria:
• • 1. locally advanced (\>T1) and/or nodal positive (N+) histologically proven adenocarcinoma of the esophagogastreal junction (AEG I-III) or the stomach without distant metastases (M0) and without infiltration of adjacent structures and organs
• • 2. no previous surgical resection
• • 3. no previous cytostatic chemotherapy
• • 4. Age \> 18 years (female and male)
• • 5. ECOG ≤ 2
• • 6. surgical resectability
• • 7. Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy
• • 8. Leucocytes \> 3.000/µl
• • 9. Platelets \> 100.000/µl
• • 10. Serum creatinin ≤ 1.5x of normal value, or Creatinin-Clearance \> 50 ml/min
• • 11. written informed consent.
• • 12. Ejection fraction \> 50% in echocardiography before start of therapy
• Exclusion Criteria:
• • 1. distant metastases or infiltration of adjacent structures or organs and all primarily not resectable stages
• • 2. relapse
• • 3. Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin. Epirubicin and Docetaxel
• • 4. Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin, Epirubicin or Docetaxel
• • 5. Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA
• • 6. malignant secondary disease, dated back \< 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)
• • 7. severe non-surgical accompanying disease or acute infection
• • 8. peripheral polyneuropathy \> NCI Grad II
• • 9. severe liver dysfunction (AST/ALT\>3,5xULN, AP\>6xULN, Bilirubin\>1,5xULN)
• • 10. chronic inflammable gastro-intestinal disease
• • 11. inclusion in another clinical trial
• • 12. pregnancy or lactation