Unique ID issued by UMIN | UMIN000015951 |
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Receipt number | R000018558 |
Scientific Title | 1st line chemotherapy of XELoda/OXaliplatin for advanced Gastric cancer PI |
Date of disclosure of the study information | 2014/12/15 |
Last modified on | 2017/06/17 10:44:07 |
1st line chemotherapy of XELoda/OXaliplatin for
advanced Gastric cancer PI
G-XELOX PI study
1st line chemotherapy of XELoda/OXaliplatin for
advanced Gastric cancer PI
G-XELOX PI study
Japan |
gastric cancer
Medicine in general | Gastroenterology | Hematology and clinical oncology |
Malignancy
NO
Determining the maximum tolerable dose(MTD) and recomended dose(RD)
Safety,Efficacy
Exploratory
Phase I
safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
capecitabine/oxaliplatin
20 | years-old | <= |
Not applicable |
Male and Female
1)histlogically proven gastric adenocarcinoma
2)chemotherapy naive
3)Performance status must be Eastern Cooperative Oncology Group (ECOG) 0, or 1
4)Age >= 20 years
5)Patients who can take medication orally
6)Adequate bone marrow, hepatic, renal, cardiac and respiratory functions
7)HER2 negative or unknown
8)Written informed consent
1) active synchronous or metachronous malignancy other than carcinoma in situ
2) pregnant or nursing
3) severe mental disorders
4) systemic steroid user
5) diabetes mellitus, uncontrolled or controlled with insulin
6) history of myocardial infarction, unstable angina within 3 months prior to the registration
7) serious coexisting illness
8) active infection
9) peripheral neuropathy greater than Grade 2
10) ileus
11) massive pleural effusion or ascites
9
1st name | |
Middle name | |
Last name | Akihito Tsuji |
Kobe City Medical Center General Hospital
Division of Oncology
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo
+81-(0)78-302-4321
hsatake@kcho.jp
1st name | |
Middle name | |
Last name | Hironaga Satake |
Kobe City Medical Center General Hospital
Division of Oncology / Gastroenterology,
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo
+81-(0)78-302-4321
hsatake@kcho.jp
Kobe City Medical Center General Hospital
Kobe City Medical Center General Hospital
Local Government
NO
2014 | Year | 12 | Month | 15 | Day |
Published
Completed
2014 | Year | 11 | Month | 25 | Day |
2014 | Year | 12 | Month | 07 | Day |
2014 | Year | 12 | Month | 15 | Day |
2017 | Year | 06 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018558
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