NCT01216644

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 716 (actual)
• Sponsor: Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	5-Fluorouracil	2600 mg/m²d1 i.v. every 2 weeks
DRUG	Leucovorin	200 mg/m², d1, i.v., every 2 weeks
DRUG	Oxaliplatin	85 mg/m², d1, i.v., every 2 weeks
DRUG	Docetaxel	50mg/m2, d1, i.v., every 2 weeks
DRUG	Epirubicin	50 mg/m2, d1, i.v., every 3 weeks
DRUG	Cisplatin	60 mg/m², d1, i.v., every 3 weeks
DRUG	5-fluorouracil	200 mg/m², d1-d21, i.v., every 3 weeks

Timeline

• Start date: 2010-08-01
• Primary completion: 2017-03-01
• Completion: 2019-05-01
• First posted: 2010-10-07
• Last updated: 2019-06-19

Locations

1 site across 1 country: Germany