FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma

Launched by BLOKHIN'S RUSSIAN CANCER RESEARCH CENTER · May 17, 2020

Keywords

ClinConnect Summary

This clinical trial is comparing two different chemotherapy treatments for patients with resectable adenocarcinoma, which is a type of stomach or esophagogastric cancer. The goal is to find out which treatment helps patients live longer after their surgery. Participants in the trial will be randomly assigned to receive either the FLOT chemotherapy combination (which includes 5-Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel) or the FOLFIRINOX combination (which includes 5-Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan) both before and after their surgery.

To be eligible for this trial, participants must be between 18 and 70 years old, have a specific type of cancer (Siewert type II-III) that has not spread to other parts of the body, and have not received prior chemotherapy or radiation. Patients should also have good overall health and meet certain blood test requirements. If you or someone you know is considering joining this trial, it's important to understand that participation involves receiving one of the two chemotherapy treatments and regular follow-up appointments to monitor health and treatment effects.

Gender

ALL

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