FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma

  • STATUS
    Recruiting
  • End date
    Jan 1, 2026
  • participants needed
    538
  • sponsor
    Blokhin's Russian Cancer Research Center
Updated on 22 April 2021
combinations
absolute neutrophil count
fluorouracil
combination chemotherapy
metastasis
oxaliplatin
gastric adenocarcinoma
neutrophil count
leucovorin
irinotecan
docetaxel
cancer chemotherapy
adenocarcinoma
5-fluorouracil
cytostatic
folfirinox

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.

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.

Details
Condition Fluorouracil, Gastrointestinal Neoplasm, GASTROINTESTINAL DISORDER, Gastrointestinal Diseases and Disorders, Neoplasm of unspecified nature of digestive system, Digestive System Neoplasms, Gastropathy, Stomach Discomfort, Gastric Cancer, Gastric Cancer, Stomach Cancer, Stomach Discomfort, Gastrointestinal Diseases and Disorders, Docetaxel, Stomach Cancer, Digestive System Neoplasms, Oxaliplatin, Irinotecan Hydrochloride, gastric neoplasm, gastric tumor, 5-fluorouracil, 5-fu, gastrointestinal tumor, gastrointestinal tract tumor, gastrointestinal tumors, digestive system tumor
Treatment docetaxel, Irinotecan, Oxaliplatin, 5-FU, Leucovorin
Clinical Study IdentifierNCT04393584
SponsorBlokhin's Russian Cancer Research Center
Last Modified on22 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

T4 cN0 or cT1-4 cN+ histologically proven adenocarcinoma of the esophagogastric junction (Siewert type II-III) or the stomach without distant metastases (M0)
No previous cytostatic chemotherapy or radiation therapy
Age 18-70 years (female and male)
Eastern Cooperative Oncology Group 2
Surgical resectability
Neutrophils> 2.000/l
Platelets > 100.000/l
Normal value of Serum Creatinin
Albumin level > 29
Aspartate transaminase (AST) or alanine transaminase (ALT) less than 3 times the upper limits of normal (ULN)
Total Bilirubin less than 1.5 times the ULN
Written informed consent

Exclusion Criteria

Previous cytostatic chemotherapy or radiation therapy
Distant metastases or all primarily not resectable stages
Cancer relapse
Complicated gastric cancer (perforation, bleeding, sub or decompensated stenosis, dysphagia IV)
Diarrhea 2 according to the criteria of Common Terminology Criteria for Adverse Events (CTCAE) version 4.1
Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Epirubicin and Docetaxel
Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan or Docetaxel
Active coronary heart disease, Cardiomyopathy or cardiac insufficiency stage III-IV according to New York Heart Association (NYHA)
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)
Malignant secondary disease, dated back < 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)
Peripheral polyneuropathy > Grad II
Liver dysfunction (AST)/ALT>3,0xULN, ALT>3xULN, Bilirubin>1,5xULN)
Serum Creatinin >1,0xULN
Chronic inflammable gastro-intestinal disease
Inclusion in another clinical trial
Pregnancy or lactation
Hepatitis B or C in the active stage
Human immunodeficiency virus(HIV) infected
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
Foreigners or persons with limited legal status
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