FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma

Last updated: April 12, 2021
Sponsor: Blokhin's Russian Cancer Research Center
Overall Status: Active - Recruiting

Phase

2/3

Condition

Digestive System Neoplasms

Gastric Ulcers

Adenocarcinoma

Treatment

N/A

Clinical Study ID

NCT04393584
2019-01
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. сT4 cN0 or cT1-4 cN+ histologically proven adenocarcinoma of the esophagogastricjunction (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 upperlimits of normal (ULN)
  11. Total Bilirubin less than 1.5 times the ULN
  12. Written informed consent.

Exclusion

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 AdverseEvents (CTCAE) version 4.1;
  6. Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Epirubicin andDocetaxel
  7. Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin,Irinotecan or Docetaxel
  8. Active coronary heart disease, Cardiomyopathy or cardiac insufficiency stage III-IVaccording to New York Heart Association (NYHA)
  9. Severe non-surgical accompanying disease or acute infection (uncontrolled arterialhypertension, 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 thecervix 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 causesthat may prevent the patient from participating in the protocol and observing theprotocol schedule
  20. Foreigners or persons with limited legal status

Study Design

Total Participants: 538
Study Start date:
January 29, 2019
Estimated Completion Date:
January 01, 2026

Study Description

538 Patients with resectable (cT4cN0 or cT1-4 and cN+, cM0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After randomization patients receive perioperatively 4 cycles FLOT or FOLFIRINOX, followed by a restaging of the tumour status and surgery. Subsequently another 4 cycles of FLOT or FOLFIRNOX are applicated.

Connect with a study center

  • Aleksei Kalinin

    Moscow, 115478
    Russian Federation

    Active - Recruiting

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