Status:
COMPLETED
5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced, Resectable Gastric Cancer
Lead Sponsor:
Krankenhaus Nordwest
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Patients with locally advanced resectable adenocarcinoma of the stomach or the esophagogastreal junction without previous therapy will be treated with one of two chemotherapy combinations before and a...
Detailed Description
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 randomi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
716 Patients enrolled
Trial Details
Trial ID
NCT01216644
Start Date
August 1 2010
End Date
May 1 2019
Last Update
June 19 2019
Active Locations (1)
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1
Krankenhaus Nordwest
Frankfurt, Germany, 60488