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A pharmacogenomics study for adverse effects and clinical outcome to S-1 in gastric cancer patients

A pharmacogenomics study for adverse effects and clinical outcome to S-1 in gastric cancer patients - Pharmacogenomics study for individual response to S-1

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000004968
Enrollment
100
Registered
2011-02-10
Start date
2011-02-01
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

gastric cancer

Interventions

None listed

Sponsors

Department of Clinical Pharmacology and Genitics, School of Pharmaceutical Science, Univercity of Shizuoka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed Gastric cancer 2) Life expectancy of at least 12 weeks at the pre-treatment evaluation 3) No prior chemotherapy or radiotherapy before enrollment 4) Oral intake is possible 5) 20 years of age or older 6) ECOG PS 0-2 7) Adequate organ function obtained within 2 weeks prior to registration. Laboratory values must be as follows; WBC count >= 3,000 /mm3, and <= 12,000 /mm3 absolute neutrophil count >= 1,500 /mm3, hemoglobin >= 8.0 g/dL platelet count >= 100,000 /mm3 AST <= 100 IU/L ALT <= 100 IU/L total bilirubin less than or equal to 1.5 mg/dL serum creatinine <= 1.5 mg/dL 8)Informed consent by the document

Exclusion criteria

Exclusion criteria: 1) Known prior severe hypersensitivity to clinical trial medicines 2) Patients who do not have enough whole body state to the antineoplastic agents treatment 3) Pregnant, breastfeeding or expecting woman 4) Other clinical difficulties in this study

Design outcomes

Primary

MeasureTime frame
To investigate the single nucleotide polymorphisms correlated with S-1 induced adverse drug reactions

Secondary

MeasureTime frame
1) To investigate the single nucleotide polymorphisms correlated with progression-free survival (advanced gastric cancer) 2) To investigate the single nucleotide polymorphisms correlated with recurrence-free survival (resectable gastric cancer)

Countries

Japan

Contacts

Public ContactDaiki Tsuji

Univercity of Shizuoka School of Pharmaceutical Science

d-tsuji@u-shizuoka-ken.ac.jp054-264-5674

Outcome results

None listed

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