UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021610 |
|---|---|
| Receipt number | 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 19:13:29 |
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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
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
t.kawakami@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024922
