The tear and plasma pharmacokinetics study of TS-1 monotherapy for gastric cancer patients.

Not Applicable

• Conditions: Gastric Cancer

• Registration Number: JPRN-UMIN000021610
• Lead Sponsor: Shizuoka Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-04
• Results First Posted: 2019-04-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

1.Patients with metachronous double cancer / multiple cancer. 2.Patients with a history, complications of diseases of the eye, patients wearing contact lenses, dry eye cases, lacrimation Grade2 or more of the cases 3.Patients with sinusitis, patients with a nose trauma. 4.Other fluoropyrimidine anti-tumor agent flucytosine. 5.continued use is required cases of phenytoin and warfarin potassium Patients. 6.Patients with a history of Grade 3 or more of severe drug allergy. 7.Cases with serious complications 8.Cases of diarrhea can not be controlled by symptomatic therapy. 9.Cases of HBs antigen-positive or HCV antibody-positive. 10.Women who may have been pregnant or nursing women, pregnancy, women with intention of pregnancy. 11.Man who are willing to be pregnant 12.Other, investigator or sub-investigator has determined to be inappropriate as a subject of the present study case.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For patients TS-1 single-agent therapy is performed as unresectable recurrent gastric cancer or gastric cancer adjuvant chemotherapy, TS-1 oral administration on day 1 and day 14 in each 0,1,2,4,6, do the tear fluid collection and plasma pharmacokinetics in a total of 12 points after 8 hours, each of the measurement object compound, tegafur (FT), the pharmacokinetic parameters for 5-fluorouracil (5-FU) and gimeracil (CDHP) calculated for each subject, the average value of each scheduled sampling time, standard deviation, to calculate summary statistics such as the coefficient of variation, to examine the correlation between the concentration of the compound in the PK and tear.