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Phase 2 study of alternate-day administrations of S-1 in elderly patients with advanced/recurrent gastric cancer (KDOG 1301)

Phase 2 study of alternate-day administrations of S-1 in elderly patients with advanced/recurrent gastric cancer (KDOG 1301) - Phase 2 study of alternate-day administrations of S-1 in elderly patients with gastric cancer (KDOG 1301)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013019
Enrollment
45
Registered
2014-01-30
Start date
2014-01-30
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

S-1

Sponsors

Department of Gastroenterology, Kitasato University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Unresectable advanced or recurrent gastric carcinoma which was confirmed histologically 2. negative or non-measurement of HER2 3. Patient with the measurable lesion 4. 76 years or older 5. ECOG performance status: 0-2 6. Chemo-naive patient 7. Sufficient organ functions in laboratory data within 14 days before enrollment 8. Possible of oral ingestion 9. Written informed consent

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity for S-1 or ingredients of S-1 2. Patient who takes flucytosine, or phenytoin 3. Severe bone marrow suppression, severe renal dysfunction, or severe liver dysfunction 4. Severe concomitant disease (congestive heart failure, hemorrhagic peptic ulcer, ileus, symptomatic ischemic heart disease, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema or etc) 5. Patient who suffered from myocardial infarction or cerebral infarction within six months 6. symptomatic brain metastasis 7. Severe mental disorders 8. Active synchronous malignancy 9. Watery diarrhea 10. HBV carrier who has to take nucleotide analogues (e.g. Entecavir) during chemotherapy 11. Patient who is judged inappropriate for the entry into this study by the investigator

Design outcomes

Primary

MeasureTime frame
response rate

Countries

Japan

Contacts

Public ContactKenji Ishido

Kitasato University School of Medicine Department of Gastroenterology

k.ishido@kitasato-u.ac.jp042-778-8111

Outcome results

None listed

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