UMIN-CTR Clinical Trial

Public title

Pharmacokinetic Study of S-1 in Cancer Patients with Varying Degrees of Renal Dysfunction
(SCHOLAR Study)

Acronym

Pharmacokinetic Study of S-1 in Cancer Patients with Varying Degrees of Renal Dysfunction
(SCHOLAR Study)

Scientific Title

Pharmacokinetic Study of S-1 in Cancer Patients with Varying Degrees of Renal Dysfunction
(SCHOLAR Study)

Scientific Title:Acronym

Pharmacokinetic Study of S-1 in Cancer Patients with Varying Degrees of Renal Dysfunction
(SCHOLAR Study)

Region

Japan

Condition

The renal failure patients scheduled to intake TS-1

Classification by specialty

Gastroenterology	Hepato-biliary-pancreatic medicine	Pneumology
Hematology and clinical oncology	Gastrointestinal surgery	Hepato-biliary-pancreatic surgery
Chest surgery	Breast surgery	Dental medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To develop a simple formula of TS-1 dosage to the patients having renal failure.

Basic objectives2

Pharmacokinetics

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

To figure Area Under The Curve by measuring 5-FU blood level of the patients having renal failure.

Key secondary outcomes

Safety within 24 hours after TS-1 intake

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

TS-1 is orally administered before breakfast and blood sample is obtained 7 times from day1 to day2.
CLcr>60

Interventions/Control_2

TS-1 is orally administered before breakfast and blood sample is obtained 7 times from day1 to day2.
59>CLcr>30

Interventions/Control_3

TS-1 is orally administered before breakfast and blood sample is obtained 7 times from day1 to day2.
29>CLcr>15

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Stage 1 to 4 of renal function
2) Age over 20 at registration
3) dosing purpose does not matter
4) prior chemotherapy include TS-1 does not matter
5) The presence or absence of measurable lesion does not matter.
6) PS 0-2
7) oral intake
8) sufficient function of organs except renal function
WBC: >=3,000/mm3 and <=12,000/mm3
Neu:>=1,500/mm3
Platelet: >=100,000/mm3
Hem: >=10.0g/dl
AST(GOT): <= 100IU/l(or 150U/L if biliary drainage were present)
ALT(GPT): <= 100IU/l(or 150U/L if biliary drainage were present)
sT.bil: <=2.0mg/dl(or 3.0mg/dl if biliary drainage were present)
9) written informed consent

Key exclusion criteria

1) pulmonary fibrosis and interstitial pneumonia
2) diarrhea
3) active infection
4) require blood transfusion within 14 days
5) severe complications
6) massive abdominal and pleural effusion
7) Being treated with flucytosine.
8) mental disease
9) Any patients judged by the investigator to be unfit to participate in the study.

Target sample size

15

Name of lead principal investigator

1st name
Middle name
Last name	Hiroya Takeuchi

Organization

Keio University, school of medecine

Division name

Div. of Gastroenterology, Dept. of Surgery

Zip code

Address

35, Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-6440

Email

htakeuchi@a6.keio.jp

Name of contact person

1st name
Middle name
Last name	Eisuke Booka

Organization

Keio University, school of medecine

Division name

Div. of Gastroenterology, Dept. of Surgery

Zip code

Address

35, Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-6440

Homepage URL

Email

ebooka@a2.keio.jp

Institute

Keio University, School of Medicine, Div. of Gastroenterology, Dept.of Surgery.

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

St. Marianna University, School of Medicine
Shinshu University, School of Medicine

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

2013

Year

09

Month

27

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2013

Year

09

Month

27

Day

Date of IRB

Anticipated trial start date

2013

Year

09

Month

27

Day

Last follow-up date

2015

Year

03

Month

31

Day

Date of closure to data entry

2015

Year

03

Month

31

Day

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

09

Month

11

Day

Last modified on

2018

Year

08

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013688