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/AClinical Study ID
NCT04393584
2019-01
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- сT4 cN0 or cT1-4 cN+ histologically proven adenocarcinoma of the esophagogastricjunction (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/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 upperlimits of normal (ULN)
- Total Bilirubin less than 1.5 times the ULN
- Written informed consent.
Exclusion
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 AdverseEvents (CTCAE) version 4.1;
- Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Epirubicin andDocetaxel
- Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin,Irinotecan or Docetaxel
- Active coronary heart disease, Cardiomyopathy or cardiac insufficiency stage III-IVaccording to New York Heart Association (NYHA)
- Severe non-surgical accompanying disease or acute infection (uncontrolled arterialhypertension, 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 thecervix 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 causesthat may prevent the patient from participating in the protocol and observing theprotocol schedule
- 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
Connect with a study center
Aleksei Kalinin
Moscow, 115478
Russian FederationActive - Recruiting
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