Unique ID issued by UMIN | UMIN000022562 |
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Receipt number | R000024561 |
Scientific Title | Phase I trial of weekly gemcitabine with radiotherapy for unresectable locally advanced biliary tract cancer. |
Date of disclosure of the study information | 2016/06/01 |
Last modified on | 2016/06/08 22:42:41 |
Phase I trial of weekly gemcitabine with radiotherapy for unresectable locally advanced biliary tract cancer.
Phase I trial of weekly gemcitabine with radiotherapy for unresectable locally advanced biliary tract cancer.
Phase I trial of weekly gemcitabine with radiotherapy for unresectable locally advanced biliary tract cancer.
Phase I trial of weekly gemcitabine with radiotherapy for unresectable locally advanced biliary tract cancer.
Japan |
Biliary tract cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
The objective is to evaluate the safety of gemcitabine combined with radiotherapy, and to decide the recommended dose.
Safety
Exploratory
Explanatory
Phase I
Adverse events within two weeks after treatment.
Maximum tolerated dose, toxicity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Chemoradiotherapy (with gemcitabine)
Radiotherapy : total 50.4Gy/28Fr. Once a day ( 1.8Gy/day), five times a week.
Gemcitabine : div day1,8,15,22,29,36
Increase the dose of gemcitabine : 400mg/m2, 500mg/m2, 600mg/m2
20 | years-old | <= |
79 | years-old | >= |
Male and Female
Unresectable locally advanced biliary tract cancer
No previous history of treatment.
30
1st name | |
Middle name | |
Last name | Michihiro Ono |
Sapporo medical university
department of medical oncology
South 1, West 16, Chuo-ku, Sapporo, Hokkaido
011-611-2111
onomichihiro34@sapmed.ac.jp
1st name | |
Middle name | |
Last name | Michihiro Ono |
Sapporo medical university
department of medical oncology
South 1, West 16, Chuo-ku, Sapporo, Hokkaido
011-611-2111
onomichihiro34@sapmed.ac.jp
Sapporo medical university, department of medical oncology
Non
Other
NO
札幌医科大学(北海道)
2016 | Year | 06 | Month | 01 | Day |
Unpublished
2016 | Year | 02 | Month | 01 | Day |
2016 | Year | 02 | Month | 01 | Day |
2016 | Year | 06 | Month | 01 | Day |
2016 | Year | 06 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024561
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