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

Last updated: April 11, 2021
Sponsor: Blokhin's Russian Cancer Research Center
Overall Status: Active - Recruiting

Phase

2

Condition

Stomach Cancer

Digestive System Neoplasms

Adenocarcinoma

Treatment

N/A

Clinical Study ID

NCT04442984
2020-01
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. histologically confirmed locally advanced, recurrent or metastatic adenocarcinoma ofthe 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 upperlimits of normal (ULN)
  10. Total Bilirubin less than 1.5 times the ULN
  11. Written informed consent.

Exclusion

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 AdverseEvents (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-IVaccording to New York Heart Association (NYHA)
  8. Severe non-surgical accompanying disease or acute infection (uncontrolled arterialhypertension, 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 thecervix 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 causesthat may prevent the patient from participating in the protocol and observing theprotocol schedule
  18. Foreigners or persons with limited legal status

Study Design

Total Participants: 326
Study Start date:
November 03, 2019
Estimated Completion Date:
November 03, 2024

Study 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.

Connect with a study center

  • Blokhin's Russian Cancer Research Center

    Moscow, 115478
    Russian Federation

    Active - Recruiting

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