A Study comparing 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) versus Epirubicin, Cisplatin and 5-FU (ECF) in patients with locally advanced resectable gastric cancer

Phase 1

• Conditions: locally advanced resectable adenocarcinoma of the esophagogastreal junction or the stomach; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-018754-13-DE
• Lead Sponsor: Krankenhaus Nordwest GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 714

Inclusion Criteria

locally advanced (>T1) and/or nodal positive (N+) histologically confirmed adenocarcinoma of the esophagogastreal junction (AEG I-III) or stomach without distant metastases (M0) or infiltration of adjacent structures or organs
no previous resection of the tumor
no previous cytostatic chemotherapy
Age > 18 years (female and male).
ECOG = 2
medical operability
In case of a clinical suspicion of peritoneal carcinomatosis an exclusion of this diagnosis via laparoscopy is required.
Leucocytes > 3.000/µl
Platelets > 100.000/µl
Serum creatinin = 1.5x of normal value, or Creatinin-Clearance > 40 ml/min
normal ejection fraction in ECG
written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 714
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 714

Exclusion Criteria

metastases or infiltration of adjacent structures or organs and all primarily not resectable stages
Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin, Epirubicin, Docetaxel and, if applicable, Capecitabine
Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin, Epirubicin, Docetaxel and, if applicable, Capecitabine
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified