PhaseII study of S-1/CDDP therapy for Gastric Cancer that Recurs After Adjuvant Chemotherapy with S-1

PhaseII study of S-1/CDDP therapy for Gastric Cancer that Recurs After Adjuvant Chemotherapy with S-1 - PhaseII study of S-1/CDDP therapy for Gastric Cancer that Recurs After Adjuvant Chemotherapy with S-1(KSCC1001)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004303

Enrollment

Registered

2010-09-30

Start date

2012-07-03

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

Gastric Cancer

Interventions

S-1 80mg/m2 (day1-21) CDDP 60mg/m2 i.v. (day8) to be repeated every 5 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent. 2. Appropriate for the study at the physician's assessment. 3. Histologically confirmed gastric adenocarcinoma. 4. Patients who have HER2-nagative cancer confirmed with IHC and/or FISH. (IHC 0 or 1+ or 2+ and FISH negative(HER2/CEP17<2.0)) 5.Treated with S-1 adjuvant chemotherapy after gastrectomy and lymph node dissection and with no residual tumor. 6. S-1 adjuvant chemotherapy continued at least 6 months. 7. No neo-adjuvant therapy. 8. No prior therapy for recurrent gastric cancer. 9. 1)measurable lesion based on the RECIST criterion. 2)evaluable lesion in contrast enhanced CT, etc. 10. ECOG performance status of 0-1. 11. 20 years of age or older. 12. Required baseline laboratory parameters .(within 14 days before registration): WBC >= 3000/mm3 , <12,000/mm3 Neu >= 1,500/mm3 Plt >= 100,000/mm3 Hb >= 9.0g/dl T-Bil <= 2.0mg/dl AST <= 100U/L (in case of hepatic metastatic patients: <= 200U/L) ALT <= 100U/L (in case of hepatic metastatic patients: <= 200U/L) Cre < 1.5mg/dl CCr >= 50mL/min HER2 negative.(IHC 0 or 1+ or 2+ and FISH negative(HER2/CEP17<2.0)) 13. be able to take oral drugs.

Exclusion criteria

Exclusion criteria: 1. Active other malignancies. 2. Prior S-1 plus other anti-cancer drugs combination chemotherapy. 3. Adjuvant chemotherapy other than S-1 mono therapy. 4. Requiring flucytosine, phenytoin, Warfarin Potassium. 5. History of the severe(grade3 or 4) hypersensitivity 6. Co-mobility, such as interstitial lung disease, lung fibrosis, intestinal paralysis, ileus, uncontrolled diabetes, uncontrolled hypertension, heart failure, serious arrhythmia, myocardial infarction, unstable angina, hepatic failure, liver cirrhosis, requiring anticoagulation therapy, requiring steroid drug, and other severe complication. 7. Active infection 8. Infection with hepatitis B or C virus 9. Watery stools or diarrhea 10. Pregnant or lactating woman 11. No birth-control 12. Mental disorder, central nerve disorder. 13. Infection with HIV virus. 14. Not appropriate for the study at the physician's assessment

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Secondary

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

Countries

Japan

Contacts

Public ContactKSCC

Clinical Research Support Center Kyushu KSCC

kscc2@cres-kyushu.or.jp092-631-2920

Outcome results

None listed

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