Clinical trial: FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma (NCT04393584)

Eligibility criteria:
Inclusion Criteria:

          1. сT4 cN0 or cT1-4 cN+ histologically proven adenocarcinoma of the esophagogastric
             junction (Siewert type II-III) or the stomach without distant metastases (M0)

          2. No previous cytostatic chemotherapy or radiation therapy

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

          4. Eastern Cooperative Oncology Group ≤ 2

          5. Surgical resectability

          6. Neutrophils> 2.000/µl

          7. Platelets > 100.000/µl

          8. Normal value of Serum Creatinin

          9. Albumin level > 29 г/л

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

         11. Total Bilirubin less than 1.5 times the ULN

         12. Written informed consent.

        Exclusion Criteria:

          1. Previous cytostatic chemotherapy or radiation therapy

          2. Distant metastases or all primarily not resectable stages

          3. Cancer relapse

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

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

          6. Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Epirubicin and
             Docetaxel

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

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

          9. 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)

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

         11. Peripheral polyneuropathy > Grad II

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

         13. Serum Creatinin >1,0xULN

         14. Chronic inflammable gastro-intestinal disease

         15. Inclusion in another clinical trial

         16. Pregnancy or lactation

         17. Hepatitis B or C in the active stage

         18. Human immunodeficiency virus(HIV) infected

         19. 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

         20. Foreigners or persons with limited legal status
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.
Subject must be at most 70 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