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Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)


Phase 3
20 Years
80 Years
Not Enrolling
Both
Gastric Cancer

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Trial Information

Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)


Inclusion Criteria:



- Age 20 to 80

- Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3

- Hepatic AST and ALT ≤ 2.5 times upper limit of normal(ULN) Total bilirubin ≤ 1.5
mg/dL

- Renal Creatinine ≤ULN

Exclusion Criteria:

- Prior anticancer treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

every course for first three courses, then every other course

Safety Issue:

No

Principal Investigator

Mitsuru Sasako, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Upper Gastrointestinal Surgery, Hyogo College of Medicine

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

91023038

NCT ID:

NCT00152217

Start Date:

September 2001

Completion Date:

December 2010

Related Keywords:

  • Gastric Cancer
  • Stomach cancer
  • Stomach Neoplasms

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