FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with resectable 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 before and after surgery. One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX). Main objective of the study is median overall survival.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

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

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