Unique ID issued by UMIN | UMIN000004682 |
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Receipt number | R000005490 |
Scientific Title | Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003) |
Date of disclosure of the study information | 2010/12/10 |
Last modified on | 2016/02/10 11:32:51 |
Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)
Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)
Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)
Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)
Japan |
Biliary Tract Cancer (Including intrahepatic cholangiocarcinoma)
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To decide MTD and/or RD of GEM or S-1 adjuvant therapy after hemihepatctomy
Safety
Exploratory
Phase I
MTD and RD
Interventional
Parallel
Non-randomized
Open -no one is blinded
Uncontrolled
2
Treatment
Medicine |
Gemcitabine
800mg/m2 - 1000mg/m2,
day 1 every 3 weeks.
day 1, 15 every 4 weeks.
day 1, 8 every 3 weeks.
day 1, 8, 15, every 4 weeks.
S-1
40mg/day - 120mg/day (depend on BSA)
day 1-14, every 3 weeks
day 1-28, every 6 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
1) Biliary tract cancer (>= UICC Stage IB)
2) R0 or R1 resection
3) ECOG PS 0 or 1
4) No other treatment than surgery for BTC
5) Neutrophil >= 1500/uL, PLT >=100,000/uL, AST, ALT <= x5 ULN, Total Bilirubin <= x3 ULN, crtn <1.2 mg/dL
6) Oral drug intake
7) 4 - 12 weeks after the surgery
8) Written informed consent
1) Active double cancer
2) Severe drug allergy
3) Severe complications (IP, HF, RF, LF, ileus, DM, etc)
4) Active infections
5) Pregnancy
6) Severe mental disorder
7) Others
6
1st name | |
Middle name | |
Last name | Hiroaki Nagano |
Osaka University, Graduate School of Medicine
Surgery
Yamadaoka 2-2, E2, Suita city, Osaka, JAPAN
1st name | |
Middle name | |
Last name | Shogo Kobayashi |
Osaka University
Surgery
Yamadaoka 2-2, E2, Suita city, Osaka, JAPAN
Kansai Hepatobiliary Oncology Group (KHBO)
Osaka Medical Center for Cancer and Cardiovascular Diseases
Other
NO
2010 | Year | 12 | Month | 10 | Day |
Published
Cancer Chemother Pharmacol. 2014 Oct;74(4):699-709
Main results already published
2010 | Year | 10 | Month | 13 | Day |
2010 | Year | 12 | Month | 01 | Day |
2010 | Year | 12 | Month | 08 | Day |
2016 | Year | 02 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005490
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