Last updated: May 16, 2022
Sponsor: University of Debrecen
Overall Status: Active - Recruiting
Phase
N/A
Condition
Stomach Cancer
Gastrointestinal Diseases And Disorders
Gastric Ulcers
Treatment
N/AClinical Study ID
NCT05238584
TOPO
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) I-III., Karnofsky Performance Score (KPS) >60, Eastern Cooperative Oncology Group (ECOG) 0-1
- Tis-T3 gastric cancer without serosal infiltration and treated with the radicaloperation (R0; D2 lymphadenectomy, lymph nodes >16)
- clinical stadium: Tis-3; M0
- written informed consent provided
- good patient compliance
- no previous chemotherapy or irradiation
Exclusion
Exclusion Criteria:
- serosal infiltration and/or distant metastasis, omental infiltration, peritonealcarcinosis, positive abdominal cytological lavage
- organ transplantation and/or immunological disease and/or immunomodulation therapy
- another primary tumor
- decompensated chronic disease (for example: liver cirrhosis with ascites, kidneyfailure treated with hemodialysis, New York Heart Association (NYHA) IV. cardiacstatus, etc.)
- unsuccessful follow-up
Study Design
Total Participants: 300
Study Start date:
January 01, 2022
Estimated Completion Date:
July 01, 2024
Study Description
Connect with a study center
University of Debrecen - Surgical Clinic
Debrecen, Hajdú - Bihar 4033
HungaryActive - Recruiting
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