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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

716 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2019-05-31

Brief Summary

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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.

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Detailed Description

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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

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

5-Fluorouracil

Intervention Type DRUG

2600 mg/m²d1 i.v. every 2 weeks

Leucovorin

Intervention Type DRUG

200 mg/m², d1, i.v., every 2 weeks

Oxaliplatin

Intervention Type DRUG

85 mg/m², d1, i.v., every 2 weeks

Docetaxel

Intervention Type DRUG

50mg/m2, d1, i.v., every 2 weeks

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

Group Type ACTIVE_COMPARATOR

Epirubicin

Intervention Type DRUG

50 mg/m2, d1, i.v., every 3 weeks

Cisplatin

Intervention Type DRUG

60 mg/m², d1, i.v., every 3 weeks

5-fluorouracil

Intervention Type DRUG

200 mg/m², d1-d21, i.v., every 3 weeks

Interventions

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5-Fluorouracil

2600 mg/m²d1 i.v. every 2 weeks

Intervention Type DRUG

Leucovorin

200 mg/m², d1, i.v., every 2 weeks

Intervention Type DRUG

Oxaliplatin

85 mg/m², d1, i.v., every 2 weeks

Intervention Type DRUG

Docetaxel

50mg/m2, d1, i.v., every 2 weeks

Intervention Type DRUG

Epirubicin

50 mg/m2, d1, i.v., every 3 weeks

Intervention Type DRUG

Cisplatin

60 mg/m², d1, i.v., every 3 weeks

Intervention Type DRUG

5-fluorouracil

200 mg/m², d1-d21, i.v., every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No