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

Launched by BLOKHIN'S RUSSIAN CANCER RESEARCH CENTER · Jun 19, 2020

Keywords

ClinConnect Summary

This clinical trial is studying two different combinations of chemotherapy to see which one helps patients with advanced stomach cancer or cancer at the junction of the esophagus and stomach live longer without their disease getting worse. One group of patients will receive a treatment called FOLFOX6, which includes a combination of three drugs: 5-Fluorouracil (5-FU), Leucovorin, and Oxaliplatin. The other group will receive a more intense treatment called mFOLFIRINOX, which adds another drug called Irinotecan to the mix.

To participate in this trial, patients must be between 18 and 70 years old and have a specific type of advanced cancer that has not been treated before. They should also be generally healthy with normal blood tests. Patients will be monitored closely during the study to understand how well each treatment works and to track any side effects. This trial is currently recruiting participants, so it’s a good opportunity for eligible patients to contribute to important research while receiving treatment.

Gender

ALL

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