UMIN-CTR Clinical Trial

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

Gastric Cancer

Classification by specialty

Gastroenterology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Shizuoka Cancer Center

Institute

Department

Personal name

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

Co-sponsor

Taiho Pharmaceutical co.,LTD

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

04

Month

04

Day

URL releasing protocol

Publication of results

Published

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

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 related 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