MedTrace Logo

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

NCT01216644 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 716

Last updated 2019-06-19

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Salah-Eddin Al-Batran, MD · Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2017-03-31
Completion
2019-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01216644 on ClinicalTrials.gov