Clinical trial: FOLFOX6 Versus mFOLFIRINOX as First Line Chemotherapy in Metastatic Gastric Cancer or Esophagogastric Junction Adenocarcinoma (Type II-III) (NCT04442984)

Eligibility criteria:
Inclusion Criteria:

          1. histologically confirmed locally advanced, recurrent or metastatic adenocarcinoma of
             the esophagogastric junction (Siewert type II-III) or the stomach

          2. no prior palliative chemotherapy or radiation therapy

          3. Age 18-70 years (female and male)

          4. Eastern Cooperative Oncology Group ≤ 2

          5. Neutrophils> 2.000/µl

          6. Platelets > 100.000/µl

          7. Normal value of Serum Creatinin

          8. Albumin level > 29 г/л

          9. Aspartate transaminase (AST) or alanine transaminase (ALT) less than 3 times the upper
             limits of normal (ULN)

         10. Total Bilirubin less than 1.5 times the ULN

         11. Written informed consent.

        Exclusion Criteria:

          1. Previous palliative cytostatic chemotherapy

          2. Cancer relapse

          3. Complicated gastric cancer (perforation, bleeding, sub or decompensated stenosis,
             dysphagia IV)

          4. Diarrhea ≥ 2 according to the criteria of Common Terminology Criteria for Adverse
             Events (CTCAE) version 4.1;

          5. Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, irinotecan

          6. Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin,
             Irinotecan or Docetaxel

          7. Active coronary heart disease, Cardiomyopathy or cardiac insufficiency stage III-IV
             according to New York Heart Association (NYHA)

          8. Severe non-surgical accompanying disease or acute infection (uncontrolled arterial
             hypertension, diabetes mellitus, stroke less than 6 months old, mental disorders,
             other tumors and others)

          9. Malignant secondary disease, dated back < 5 years (exception: In-situ-carcinoma of the
             cervix uteri, adequately treated skin basal cell carcinoma)

         10. Peripheral polyneuropathy > Grad II

         11. Liver dysfunction (AST)/ALT>3,0xULN, ALT>3xULN, Bilirubin>1,5xULN) Serum Creatinin
             >1,0xULN

         12. Chronic inflammable gastro-intestinal disease

         13. Inclusion in another clinical trial

         14. Pregnancy or lactation

         15. Hepatitis B or C in the active stage

         16. Human immunodeficiency virus(HIV) infected

         17. Serious concomitant somatic and mental illnesses / deviations or territorial causes
             that may prevent the patient from participating in the protocol and observing the
             protocol schedule

         18. Foreigners or persons with limited legal status
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years

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? 1