Unique ID issued by UMIN | UMIN000023880 |
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Receipt number | 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 13:22:55 |
Validation Study of the S-1 dosage formula based on renal function (SCHOLAR Study: Part 2)
Validation Study of the S-1 dosage formula based on renal function (SCHOLAR Study: Part 2)
Validation Study of the S-1 dosage formula based on renal function (SCHOLAR Study: Part 2)
Validation Study of the S-1 dosage formula based on renal function (SCHOLAR Study: Part 2)
Japan |
Patients with cancer scheduled to have S-1 monotherapy
Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Pneumology | Hematology and clinical oncology | Surgery in general |
Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Adult |
Malignancy
NO
To confirm PK and safety when S-1 calculated by B-B formula was administered
Safety
To confirm AUC of 5-FU was valid when S-1 calculated by B-B formula was administered
To evaluate safety when S-1 calculated by B-B formula was administered
Interventional
Parallel
Non-randomized
Open -no one is blinded
Dose comparison
3
Treatment
Medicine |
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
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
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
20 | years-old | <= |
Not applicable |
Male and Female
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
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.
30
1st name | Hirofumi |
Middle name | |
Last name | Kawakubo |
Keio University School of medicine
Department of Surgery
160-8582
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-3353-1211
hkawakubo@z3.keio.jp
1st name | Hirofumi |
Middle name | |
Last name | Kawakubo |
Keio University School of medicine
Department of Surgery
160-8582
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-3353-1211
hkawakubo@z3.keio.jp
Keio University School of medicine
Keio University School of medicine
Self funding
Keio University School of Medicine, Ethics Committee
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
NO
2016 | Year | 09 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 09 | Month | 01 | Day |
2016 | Year | 11 | Month | 10 | Day |
2016 | Year | 11 | Month | 10 | Day |
2018 | Year | 03 | Month | 22 | Day |
2016 | Year | 08 | Month | 31 | Day |
2019 | Year | 08 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027507
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