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

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Disease Information

Descriptive Information
Brief Title † 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced, Resectable Gastric Cancer
Official Title † A Randomized Multicenter Phase II/III Study Comparing 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced Resectable Adenocarcinoma of the Esophagogastreal Junction or the Stomach
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 after surgery. One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others Epirubicin, Cisplatin and 5-FU (ECF). Main objective of the study is median overall survival.
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 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, histopathologic regression rate and R0-resection rate.
Study Phase Phase 2/Phase 3
Study Type † Interventional
Study Design †
Primary Outcome Measure † median overall survival
Secondary Outcome Measure † histopathological regression rate
Condition † Gastric Cancer
Intervention † Drug5-Fluorouracil
Study Arms / Comparison Groups FLOT Docetaxel 50mg/m2, d1 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (8 weeks) pre-OP and 4 cycles (8 weeks) post-OP ECF Epirubicin 50 mg/m2, d1 Cisplatin 60 mg/m², d1 5-FU 200 mg/m², d1-d21 every 3 weeks (q3w) 3 cycles (9 weeks) pre-OP and 3 cycles (9 weeks) post-OP
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 716
Start Date † July 2010
Completion Date June 2017
Primary Completion Date June 2017
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 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
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Germany
Administrative Information
NCT ID † NCT01216644
Organization ID FLOT4
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Krankenhaus Nordwest
Collaborators ††
Investigators † Principal Investigator: Salah-Eddin Al-Batran, MD, Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany
Information Provided By
Verification Date March 2017
First Received Date † June 30, 2010
Last Updated Date March 6, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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