This trial is active, not recruiting.

Condition gastric cancer
Treatments 5-fluorouracil, leucovorin, oxaliplatin, docetaxel, epirubicin, cisplatin
Phase phase 2/phase 3
Sponsor Krankenhaus Nordwest
Start date July 2010
End date December 2016
Trial size 716 participants
Trial identifier NCT01216644, FLOT4


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
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
2600 mg/m²d1 i.v. every 2 weeks
200 mg/m², d1, i.v., every 2 weeks
85 mg/m², d1, i.v., every 2 weeks
50mg/m2, d1, i.v., every 2 weeks
(Active Comparator)
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
50 mg/m2, d1, i.v., every 3 weeks
60 mg/m², d1, i.v., every 3 weeks
200 mg/m², d1-d21, i.v., every 3 weeks

Primary Outcomes

median overall survival
time frame: 2 years follow-up

Secondary Outcomes

histopathological regression rate
time frame: 6 weeks after surgery
disease free survival (DFS)
time frame: 2 years follow-up
correlation of pCR and DFS with survival
time frame: 2 years follow-up
Perioperative Morbidity and Mortality
time frame: up to 2 months after surgery
R0-Resection rate
time frame: 2 months after surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Salah-Eddin Al-Batran, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Krankenhaus Nordwest.