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

• Status: Recruiting
• Trial end date: 2024-11-03
• Target enrollment: 0
• Participant gender: All

Summary

Patients with metastatic adenocarcinoma of the stomach or the esophagogastric junction (II-III type by Siewert) without previous therapy will be treated with one of two chemotherapy combinations . One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin (FOLFOX6), the others 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Irinotecan (mFOLFIRINOX). Main objective of the study is progression free survival.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Blokhin's Russian Cancer Research Center
• Treatments: Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin

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