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Al-Batran S, et al. "FLOT vs. ECF/ECX for locally advanced, resectable gastric or GEJ adenocarcinoma". The Lancet. 2019. 393(10184):1948-1957.
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Clinical Question

Among patients with histologically-confirmed advanced clinical stage cT2 or higher and/or nodal positive stage (cN+) resectable tumours, with no evidence of distant metastases, is FLOT superior to ECX/ECF for overall survival?

Bottom Line

FLOT is superior to ECX/ECF for median overall survival.


  • Controlled, open-label, phase 2/3 trial
  • N=716
    • FLOT (n=356)
    • ECX/ECF (n=360)
  • Setting: 38 German hospitals or with practice-based oncologists
  • Enrolment: 2010-2015
  • Analysis: Intention-to-treat
  • Primary outcomes:
    • Median overall survival [Time Frame: 2 years follow-up]
  • Secondary outcomes:
    • Margin-free-(R0) resection rate [Time Frame: 2 years follow-up]
    • Disease-free survival [Time Frame: 2 years follow-up]
    • Surgical morbidity and mortality [Time Frame: up to 2 months after surgery]
    • Adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 3
    • Histopathological regression rate [Time Frame: 6 weeks after surgery]


Inclusion Criteria

  • 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
  • No previous surgical resection
  • No previous cytostatic chemotherapy
  • Age > 18 years (female and male)
  • ECOG ≤ 2
  • Surgical resectability
  • Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy
  • Leucocytes > 3.000/µl
  • Platelets > 100.000/µl
  • Serum creatinin ≤ 1.5x of normal value, or Creatinin-Clearance > 50 ml/min
  • Written informed consent.
  • Ejection fraction > 50% in echocardiography before start of therapy

Exclusion Criteria

  • Distant metastases or infiltration of adjacent structures or organs and all primarily not resectable stages
  • Relapse
  • Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin. Epirubicin and Docetaxel
  • Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin, Epirubicin or Docetaxel
  • Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA
  • Malignant secondary disease, dated back < 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)
  • Severe non-surgical accompanying disease or acute infection
  • Peripheral polyneuropathy > NCI Grad II
  • Severe liver dysfunction (AST/ALT>3,5xULN, AP>6xULN, Bilirubin>1,5xULN)
  • Chronic inflammable gastro-intestinal disease
  • Inclusion in another clinical trial
  • Pregnancy or lactation