Clinical trial: 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced, Resectable Gastric Cancer (NCT01216644)

Eligibility 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment