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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023880
Receipt No. R000027507
Scientific Title Validation Study of the S-1 dosage formula based on renal function (SCHOLAR Study: Part 2)
Date of disclosure of the study information 2016/09/01
Last modified on 2019/08/06

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Basic information
Public title Validation Study of the S-1 dosage formula based on renal function (SCHOLAR Study: Part 2)
Acronym Validation Study of the S-1 dosage formula based on renal function (SCHOLAR Study: Part 2)
Scientific Title Validation Study of the S-1 dosage formula based on renal function (SCHOLAR Study: Part 2)
Scientific Title:Acronym Validation Study of the S-1 dosage formula based on renal function (SCHOLAR Study: Part 2)
Region
Japan

Condition
Condition Patients with cancer scheduled to have S-1 monotherapy
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Hematology and clinical oncology Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm PK and safety when S-1 calculated by B-B formula was administered
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To confirm AUC of 5-FU was valid when S-1 calculated by B-B formula was administered
Key secondary outcomes To evaluate safety when S-1 calculated by B-B formula was administered

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1 is orally administered before breakfast and blood sample is obtained 6 times from day1 to day2.
S-1 is administered for 4 weeks and rest for 2 weeks.
CLcr>60
Interventions/Control_2 S-1 is orally administered before breakfast and blood sample is obtained 6 times from day1 to day2.
S-1 is administered for 4 weeks and rest for 2 weeks.
59>CLcr>30
Interventions/Control_3 S-1 is orally administered before breakfast and blood sample is obtained 6 times from day1 to day2.
S-1 is administered for 4 weeks and rest for 2 weeks.
29>CLcr>15
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Scheduled to S-1 monotherapy
2) CLcr>15mL/min
3) Age over 20 at registration
4) prior chemotherapy include S-1 does not matter
5) The presence or absence of measurable lesion does not matter.
6) PS 0, 1
7) oral intake
8) sufficient function of organs except renal function
WBC: >=3,500/mm3 and <=12,000/mm3
Neu:>=2,000/mm3
Platelet: >=100,000/mm3
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: <=1.5mg/dl
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) dialysis
7) massive abdominal and pleural effusion
8) Being treated with flucytosine.
9) mental disease
10) hypersensitive to 5-FU
11) Any patients judged by the investigator to be unfit to participate in the study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hirofumi
Middle name
Last name Kawakubo
Organization Keio University School of medicine
Division name Department of Surgery
Zip code 160-8582
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Email hkawakubo@z3.keio.jp

Public contact
Name of contact person
1st name Hirofumi
Middle name
Last name Kawakubo
Organization Keio University School of medicine
Division name Department of Surgery
Zip code 160-8582
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email hkawakubo@z3.keio.jp

Sponsor
Institute Keio University School of medicine
Institute
Department

Funding Source
Organization Keio University School of medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine, Ethics Committee
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel 03-5363-3503
Email med-rinri-jimu@adst.keio.ac.jp

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 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
2016 Year 11 Month 10 Day
Anticipated trial start date
2016 Year 11 Month 10 Day
Last follow-up date
2018 Year 03 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 31 Day
Last modified on
2019 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027507

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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