NCT00197431

Brief Summary

S-1 is a novel oral fluorouracil antitumor drug that consists of tegafur which is a prodrug of 5-fluorouracil (5-FU); 5-chloro-2,4-dihydropyridine (CDHP), which inhibits dihydropyrimidine dehydrogenase (DPD) activity; and potassium oxonate (Oxo), which reduces gastrointestinal toxicity. 5-FU is metabolized by CYP2A6 and DPD. In this study, the researchers investigate the influences of differences in activities of CYP2A6 and DPD on pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes in digestive organ cancer patients treated with S-1.

Trial Health

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Trial Health Score

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Geographic Reach
1 country

1 active site

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

March 22, 2006

Status Verified

December 1, 2003

First QC Date

September 12, 2005

Last Update Submit

March 21, 2006

Conditions

Gastric CancerEsophageal CancerPancreatic CancerColon Cancer

Outcome Measures

Primary Outcomes (1)

  • Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes

Secondary Outcomes (1)

  • Side effect and motility of patients treated with S-1

Interventions

S-1DRUG

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with digestive organ cancer

You may not qualify if:

  • Patients without digestive organ cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

RECRUITING

MeSH Terms

Conditions

Stomach NeoplasmsEsophageal NeoplasmsPancreatic NeoplasmsColonic Neoplasms

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesColorectal NeoplasmsIntestinal NeoplasmsColonic DiseasesIntestinal Diseases

Study Officials

  • Naohito Shirai, MD., PhD

    Department Laboratory Medicine, Hamamatsu University School of Medicine

    STUDY CHAIR

Central Study Contacts

Naohito Shirai, MD., PhD

CONTACT

81-534-2788naohito@hama-med.ac.jp

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

January 1, 2004

Last Updated

March 22, 2006

Record last verified: 2003-12

Locations

JP(1)