UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011708 |
|---|---|
| Receipt number | R000013688 |
| Scientific Title | Pharmacokinetic Study of S-1 in Cancer Patients with Varying Degrees of Renal Dysfunction (SCHOLAR Study) |
| Date of disclosure of the study information | 2013/09/27 |
| Last modified on | 2018/08/30 10:43:37 |
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Basic information
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
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
Objectives
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
Assessment
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
htakeuchi@a6.keio.jp
Public contact
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
ebooka@a2.keio.jp
Sponsor or person
Institute
Keio University, School of Medicine, Div. of Gastroenterology, Dept.of Surgery.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
St. Marianna University, School of Medicine
Shinshu University, School of Medicine
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
| 2013 | Year | 09 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 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
Other related information
Management 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
