The relationship between ocular toxicity induced by S-1 and pharmacokinetic analysis in both blood and tear

The relationship between ocular toxicity induced by S-1 and pharmacokinetic analysis in both blood and tear - The relationship between ocular toxicity induced by S-1 and pharmacokinetic analysis in both blood and tear

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015415

Enrollment

100

Registered

2014-11-01

Start date

2014-10-01

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

Malignancy

Interventions

S-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed malignancy 2) Advanced cancers that S-1 are effective or gastric cancers that S-1 is indicated as adjuvant chemotherapy 3) Age is over 20 years. 4) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 5)Adequate organ function, evidenced by following laboratory results within 14 days prior to starting chemotherapy. Absolute neutrophil count>1,500/mm3 Platelet count<100,000/mm3 Hemoglobin<8.0g/dl Total bilirubin<2.0mg/dl AST and ALT<2.5 times the upper limit of normal(ULN) Creatinine<1.5mg/dl 6)Signed, written informed concent is obtained.

Exclusion criteria

Exclusion criteria: 1) interstitial pneumonia, pulmonary fibrosis 2) Severe active infection 3) Serological positive for HBs-antigen or HCV-antibody 4) Unstable angina or myocardial infarction within 3 months 5) Severe complication (e.g., uncontrollable diabetis mellitus, liver disease) 6) Active synchronous cancer 7) Severe psychiatric disorder 8) Pregnant or lactating women, or men and women without wanting pregnancy 9) Severe hypersensitivity to medicine 10) Patients who were judged inappropriate for the study

Design outcomes

Primary

Measure	Time frame
To identify the pharmacokinetic factors that is associated with ocular toxicity induced by S-1	—

Countries

Japan

Contacts

Public ContactHiroo Ishida

Showa University School of Medicine Division of Medical Oncology, Department of Medicine

hishida@med.showa-u.ac.jp03-3784-8000

Outcome results

None listed

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