Status:
UNKNOWN
FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma
Lead Sponsor:
Blokhin's Russian Cancer Research Center
Conditions:
Stomach Neoplasms
Gastrointestinal Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief 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 befor...
Detailed 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 p...
Eligibility Criteria
Inclusion
- сT4 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/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 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
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
538 Patients enrolled
Trial Details
Trial ID
NCT04393584
Start Date
January 29 2019
End Date
January 1 2026
Last Update
April 13 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Aleksei Kalinin
Moscow, Russia, 115478