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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021610
Receipt No. R000024922
Scientific Title The tear and plasma pharmacokinetics study of TS-1 monotherapy for gastric cancer patients.
Date of disclosure of the study information 2016/04/04
Last modified on 2019/04/24

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Basic information
Public title The tear and plasma pharmacokinetics study of TS-1 monotherapy for gastric cancer patients.
Acronym The TS-1 tear study-01
Scientific Title The tear and plasma pharmacokinetics study of TS-1 monotherapy for gastric cancer patients.
Scientific Title:Acronym The TS-1 tear study-01
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the relevance of pharmacokinetics in plasma of tear fluid of Gastric cancer patients with TS-1 monotherapyand.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Tears collection and blood sumpling for pharmacokinetics
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1.There is no treatment history of TS-1, gastric cancer patients to receive the first TS-1 therapy.
2.Cases of treatment of TS-1 is likely to be continued 1 course.
3.Creatinine clearance 60mL / min or more of the cases.
4.Cases of cases of age is below 80 years of age or 20 years of age at the time of registration.
5.After the start of treatment, it has been desired or consent hospitalization of a total of four days cases.
6.Cases of consent in writing has been obtained.
Key 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.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirofumi Yasui and Hiroya Kashiwagi
Organization Shizuoka Cancer Center
Division name Division of Gastrointestinal oncology and Opthalmology
Zip code
Address 1007 Shimonagakubo Nagaizumi-cho Sunto-gun Shizuoka,Japan
TEL 055-989-5222
Email h.yasui@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Kawakami
Organization Shizuoka Cancer Center
Division name Division of Gastrointestinal oncology
Zip code
Address 1007 Shimonagakubo Nagaizumi-cho Sunto-gun Shizuoka,Japan
TEL 055-989-5222
Homepage URL
Email t.kawakami@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

Funding Source
Organization Public Interest Incorporated Foundation- Shizuoka Industrial Foundation- Pharma Valley Center, Clinical Trial Promotion Section, Shizuoka, Japan.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Taiho Pharmaceutical co.,LTD
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s10147-018-01387-6
Number of participants that the trial has enrolled 8
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 04 Month 22 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 01 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 25 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024922

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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