Unique ID issued by UMIN | UMIN000008415 |
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Receipt number | R000009765 |
Scientific Title | Phase I study of chemotherapy with gemcitabine, CDDP and S-1 for the patients with unresectable biliary tract cancer |
Date of disclosure of the study information | 2012/07/12 |
Last modified on | 2017/07/19 11:03:58 |
Phase I study of chemotherapy with gemcitabine, CDDP and S-1 for the patients with unresectable biliary tract cancer
Chemotherapy for the patients with unresectable biliary tract
Phase I study of chemotherapy with gemcitabine, CDDP and S-1 for the patients with unresectable biliary tract cancer
Chemotherapy for the patients with unresectable biliary tract
Japan |
biliary tract cancer
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the safity and toxicity of the treatment with GEM/CDDP/S-1 and to determine the MTD and RD
Safety,Efficacy
Phase I
To evaluate the safety and determine RD
Interventional
Single arm
Non-randomized
Open -no one is blinded
Dose comparison
1
Treatment
Medicine |
dose escalation
20 | years-old | <= |
80 | years-old | > |
Male and Female
1)The patients with inoperable advanced biliary tract cancer including intrahepatic cholangiocarcinoma and ampullary carcinoma diagnosed by pathologically methods or graphically visualizes examination Patients with post-operative recurrent is excluded)
2)Patients of age =>20 and 80>
3)Patientswith Eastern Chemotherapy Oncology Group (ECOG) performance status of 0,1
4)Life expectancy more than 3 months
5)Hemoglobin >=9.0g/dl,
WBC>=3,000/mm3,12,000/mm3,
neutrophils >=1,500/mm3, platelets >=100,000/mm3,
AST/ALT </=100,
Total bilirubin </=2.0 x ULN,
Serum creatinine </=1.0 x ULN,
BUN </=1.0 x ULN,
PaO2 >= 70 torr
Creatinine clearance>=60 ml/min
6)No other treatments, such as radiation or chemotherapy
7)Written informed consent
1)Pulmonary fibrosis or interstitial pneumonia detectable on chest X-ray
2)Active infection
3)Uncontrollable heart disease and myocardial infarction within 6 months
4)Uncontrollable DM
5)Pregnant or lactation women, or women with known or suspected pregnancy
6)History of severe drug allergy
7)Active synchronous or metachronous malignancy
24
1st name | |
Middle name | |
Last name | Tadashi Uwagawa |
Jikei University School of Medicine
Department of Surgery, Division of hepatobiliary pancreatic surgery
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
03-3433-1111
uwatadashi@msn.com
1st name | |
Middle name | |
Last name | Tadashi Uwagawa |
Jikei University School of Medicine
Department of surgery, Division of hepatobiliary pancreatic surgery
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
03-3433-1111
uwagawa@jikei.ac.jp
Jikei University School of Medicine
Jikei University school of Medicine
Department of surgery
Division of hepatobiliary pancreatic surgery
Self funding
NO
東京慈恵会医科大学附属病院
2012 | Year | 07 | Month | 12 | Day |
Unpublished
Completed
2012 | Year | 05 | Month | 28 | Day |
2012 | Year | 07 | Month | 01 | Day |
2012 | Year | 07 | Month | 12 | Day |
2017 | Year | 07 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009765
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