A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone for Serosa-negative Advanced Gastric Cancer (NSAS-GC)
Phase 3
20 Years
75 Years
20 Years
75 Years
Not Enrolling
Both
Gastric Cancer
Both
Gastric Cancer
Trial Information
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone for Serosa-negative Advanced Gastric Cancer (NSAS-GC)
Inclusion Criteria:
- Age 20 to 75
- Performance status 0 , 1, or 2 (ECOG)
- Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3
- Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.5
times ULN
- Renal BUN ≤1.5 times ULN Creatinine ≤ 1.5 times ULN
Exclusion Criteria:
- Prior anticancer treatment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival and relapse-free survival
Outcome Time Frame:
every course for first three courses, then every other course
Safety Issue:
No
Principal Investigator
Toshifusa Nakajima, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Institute Hospital
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
01023003
NCT ID:
NCT00152243
Start Date:
June 1997
Completion Date:
August 2007
Related Keywords:
- Gastric Cancer
- Stomach Cancer
- Stomach Neoplasms
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