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Phase II trial of S-1 therapy for advanced or recurrent esophageal cancer resistant or intolerable existing treatments

Phase II trial of S-1 therapy for advanced or recurrent esophageal cancer resistant or intolerable existing treatments - Phase II trial of S-1 therapy for advanced or recurrent esophageal cancer resistant or intolerable existing treatments

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023736
Enrollment
50
Registered
2016-08-26
Start date
2016-08-26
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

esophageal cancer

Interventions

S-1 treatment (day1-28)

Sponsors

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) advanced or recurrent esophageal cancer proven histologically 2) aged >= 20 years old 3) ECOG PS of 0, 1 or 2 4) resistant or intolerable existing treatments 5) adequate food intake 6) with measurable lesions 7) Adequate organ functions 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Previous treatment with S-1 2) With active diseases (interstitial pneumonia, fibroid lung, intestinal obstruction, uncontrollable diabetes millutus or hypertentsion, history of myocardial infarction within 6 months, or unstable angina pectoris, liver cirrhosis, renal failure) 3) Simultaneous or metachronous cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer 4) History of severe allergic reactions to pyrimidine fluoride drug 5) Active infection 6) With severe diarrhea 7) With symptomatic metastasis to nerve 8) Psychosis 9) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium 10) Pregnant or lactating women, women of childbearing potential or women who like to have children in future 11) Participant to other clinical trials 12) Any patients judged by the investigator to be unfit to participate in the study

Design outcomes

Primary

MeasureTime frame
progression free survival

Countries

Japan

Contacts

Public ContactYoshito Hayashi

Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology

y.hayashi@gh.med.osaka-u.ac.jp06-6879-5111

Outcome results

None listed

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