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

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Krankenhaus Nordwest
• Treatments: Cisplatin; Docetaxel; Epirubicin; Fluorouracil; Leucovorin; Oxaliplatin

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 < 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