Status:
UNKNOWN
FOLFOX6 Versus mFOLFIRINOX as First Line Chemotherapy in Metastatic Gastric Cancer or Esophagogastric Junction Adenocarcinoma (Type II-III)
Lead Sponsor:
Blokhin's Russian Cancer Research Center
Conditions:
Gastric Carcinoma Stage IV
Esophagogastric Junction Adenocarcinoma Stage IV
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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/µl
- Platelets \> 100.000/µl
- Normal value of Serum Creatinin
- Albumin level \> 29 г/л
- 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
- 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
Key Trial Info
Start Date :
November 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 3 2024
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT04442984
Start Date
November 3 2019
End Date
November 3 2024
Last Update
April 13 2021
Active Locations (1)
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1
Blokhin's Russian Cancer Research Center
Moscow, Russia, 115478