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Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer

Phase 3
20 Years
74 Years
Not Enrolling
Gastric Cancer

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Trial Information

Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer

This is a randomized, controlled, open-label, parallel, multicenter study. Patients are
stratified according to 3 factors ; performance status (ECOG scale: 0, 1, 2), disease stage
(unresectable gastric cancer or recurrent gastric cancer (received prior adjuvant
chemotherapy or not)) and participating center. Patients are randomized to one of two
treatment arms. Arm A: Patients receive oral TS-1 twice daily on days 1-28 followed by 14
days rest. Treatment is repeated every 42 days for up to 4 courses. Arm B: Patients receive
CDDP iv on day 8 and oral TS-1 twice daily on days 1-21 followed by 14 days rest. Treatment
is repeated every 35 days for up to 5 courses. Patients are followed every 6 months for up
to 2 years from the day they participates in this study.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma

- Unresectable and recurrent gastric cancer

- Age 20 to 74

- Performance status 0, 1, or 2 (ECOG)

- Life expectancy 3 months

- No prior chemotherapy or radiotherapy for gastric cancer

- Able to take oral medication

- Evaluable or not evaluable lesion had already checked more than 28 days before
participated in this study

- Hematopoietic Absolute granulocyte count lower limit of normal-12,000/mm^3 Platelet
≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL

- Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤
1.5 mg/dL

- Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 50 mL/min

Exclusion Criteria:

- Pregnant or nursing

- Bleeding from gastrointestinal tract or no diarrhea

- Hypersensitivity to TS-1 or CDDP

- Psychiatric disorder that would preclude study compliance or giving informed consent

- Severe acute or chronic medical or psychiatric condition or laboratory abnormality

- Serious illness or medical condition

- Brain metastasis

- Ascites requiring drainage

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

every course for first three courses, then every other course

Safety Issue:


Principal Investigator

Wasaburo Koizumi, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

East Hospital, Kitasato University


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

March 2002

Completion Date:

December 2006

Related Keywords:

  • Gastric Cancer
  • Stomach cancer
  • Stomach Neoplasms