Randomized phase II study of daily administrations versus alternate-day administrations of TS-1 in advanced or recurrent gastric cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004578

Enrollment

120

Registered

2010-12-01

Start date

2010-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or recurrent gastric cancer

Interventions

Daily administrations: TS-1 is administered orally for 28 days, followed by 14 days rest. Alternate-day administrations: TS-1 is administered orally at Monday, Wednesday, Friday and Sunday.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically demonstrated adenocarcinoma of advanced or recurrent gastric carcinoma. 2) Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors. (RECIST) 3) No prior radiotherapy, chemotherapy or hormone therapy. 4) Adequate organ functions: i) WBC >=3000/mm3 and <=12000/mm3, ii) neutrophils >=2000/mm3, iii) platelets >=100,000/mm3, iv) hemoglobin >=8.0g/dL, v) total bilirubin <=1.5mg/dL, vi) AST(GOT)/ALT(GPT) <=100IU/L, vii) creatinine clearance >=50mL/min. 5) ECOG Performance status:0-2 6) Expected survival over 3 months. 7) Age of 20 years or older. 8) Sufficient oral intake. 9) Normal ECG. 10) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Limitation of use of TS-1. 2) Infection and inflammation. 3) Serious heart disease. 4) Symptomatic pulmonary fibrosis or interstitial pneumonia. 5) Severe complications, such as ileus, uncontrolled diabetes mellitus, heart failure, renal failure and hepatocirrhosis. 6) A large amount of pleural effusion or peritoneal fluid. 7) Widespread bone-marrow metastases. 8) Brain metastasis. 9) Fresh bleeding from digestive organs. 10) Diarrhea. 11) Severe mental disorders. 12) Active synchronous malignancy. 13) Patients under treatment with flucytosine, phenytoin or warfarin potassium. 14) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 15) Other patients who are unfit for the study as determined by the attending physician.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Secondary

Measure	Time frame
Safety, Overall Survival, Time to Treatment Failure, Disease Control Rate and Response Rate	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026