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

  • STATUS
    Recruiting
  • End date
    Nov 3, 2024
  • participants needed
    326
  • sponsor
    Blokhin's Russian Cancer Research Center
Updated on 21 April 2021

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.

Description

This parallel, randomized, open-label study 326 patients with metastatic ( adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After randomization patients receive 9 cycles FOLFOX6 or mFOLFIRINOX.

Stratification factors include ECOG, site of metastasis, age, pathological subtypes.

Efficacy will be evaluated every 3 cycles with RECIST. Toxicity will be assessed with WHO CTC 3.0 every 2 weeks.

Details
Condition Gastric Carcinoma Stage IV, Esophagogastric Junction Adenocarcinoma Stage IV
Treatment Irinotecan, Oxaliplatin, 5-FU, Leucovorin
Clinical Study IdentifierNCT04442984
SponsorBlokhin's Russian Cancer Research Center
Last Modified on21 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

histologically confirmed locally advanced, recurrent or metastatic adenocarcinoma of the esophagogastric junction (Siewert type II-III) or the stomach
no prior palliative chemotherapy or radiation therapy
Age 18-70 years (female and male)
Eastern Cooperative Oncology Group 2
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 palliative cytostatic chemotherapy
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, irinotecan
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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