A Phase II study of combination chemotherapy with TS-1 and Trastuzumab for patients with HER2 positive advanced or recurrent gastric cancer.

A Phase II study of combination chemotherapy with TS-1 and Trastuzumab for patients with HER2 positive advanced or recurrent gastric cancer. - STAR study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008220

Enrollment

Registered

2012-06-20

Start date

2012-02-01

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

Drug:TS-1 and Trastuzumab TS-1:80mg/m2 on Day 1-28 Trastuzumab:6mg/kg on Day 1 and Day 22 (first time: 8mg/kg)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histopathological confirmation of Adenocarcinoma 2) Unresectable or recurrent gastric cancer 3) Previously-treated patient 4) HER2-positive tumor 5) Age 20 6) ECOG performance status of 0 to 2 7) Adequate organ function as follows: 1.Neu : >= 1,500 /mm3 2.Platelet : >= 100,000 /mm3 3.hemoglobin : >= 9.0 g/dL 4.AST, ALT : < 100 IU/L 5.St.bil : < 1.5 mg/dL 6.Serum creati : <= 1.2 mg/dL 7.Ccr : >= 60 ml/min 8) Ejection fraction more than 50% by ultrasound or MUGA 9) Normal electrocardiogram which was performed within 21 days 10) Sufficient oral intake 11) Expected more than 3 months survival 12) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Prior chemotherapy of TS-1 2) With severe allergy to TS-1 and Trastuzumab 3) Women in pregnancy, at risk of pregnancy, hoping to become pregnant. Men who want their partners to become pregnant. 4) Active infection and inflammation. 5) History of cardiac disease 6) Patients with Severe complications 7) Patients with resting dyspnea 8) Patients with gastrointestinal ulceration and bleed 9) Patients with diarrhea (4 or more times per day or watery diarrhea). 10) Massive pleural or abdominal effusion 11) Patients with metastasis to CNS 12) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 13) Patients under treatment with flucytosine, phenytoin or warfarin potassium 14) Patients who are received systemic administration of corticosteroid. 15) Other patients who are unfit for the study as determined by the attending physician.

Design outcomes

Primary

Measure	Time frame
treatment completion ratio	—

Secondary

Measure	Time frame
respons rete, progression-free survival, overall survival, time to treatment failure, Safety	—

Countries

Japan

Contacts

Public ContactNaotoshi Sugimoto

Osaka medical center for cancer and cardiovascular diseases Department of Clinical Oncology

sugimoyo-na2@mcpref.osaka.jp06-6972-1181

Outcome results

None listed

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