Unique ID issued by UMIN | UMIN000011164 |
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Receipt number | R000013076 |
Scientific Title | Hepatectomy + XELOX for Liver Metastasis of Colorectal Cancer. |
Date of disclosure of the study information | 2013/07/20 |
Last modified on | 2019/02/09 09:15:32 |
Hepatectomy + XELOX for Liver Metastasis of Colorectal Cancer.
adjXELOX study
Hepatectomy + XELOX for Liver Metastasis of Colorectal Cancer.
adjXELOX study
Japan |
colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
feasibility of adjuvant XELOX for post curative resection of liver metastasis from colorectal cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
completion rate of adjuvant chemotherapy
OS,PFS,AE,recurrence,dose-intensity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
adjuvant Xeloda followed by XELOX total 5 course after curative resection of liver metastasis from colorectal carcinoma.
20 | years-old | <= |
Not applicable |
Male and Female
1)histlogically proven colorectal carcinoma
2)Curatively resected metastatic liver tumors form colorectal cancer
3)No extrahepatic sites of disease
4)wihtin 90 days from the date of liver resection
5)age >= 20 years
6)Performance status must be Eastern Cooperative Oncology Group (ECOG) 0, or 1
7)No prior chemotherapy and radiotherapy to the liver
8)Adequate bone marrow, hepatic, renal, cardiac and respiratory functions
9)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
27
1st name | |
Middle name | |
Last name | Akihito Tsuji |
Kobe City Medical Center General Hospital
medical oncology
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
0783024321
hsatake@kcho.jp
1st name | |
Middle name | |
Last name | Hironaga Satake |
Kobe City Medical Center General Hospital
medical oncology
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
0783024321
takeh1977@gmail.com
Kobe City Medical Center General Hospital
Kobe City Medical Center General Hospital
Local Government
Kobe City Medical Center West Hospital,Nishikobe Medical Center,Takarazuka city hospital,Himeji red cross hospital,Nishinomiya Hospital et al.
NO
2013 | Year | 07 | Month | 20 | Day |
Unpublished
Main results already published
2013 | Year | 03 | Month | 22 | Day |
2013 | Year | 05 | Month | 01 | Day |
2017 | Year | 04 | Month | 30 | Day |
2019 | Year | 04 | Month | 30 | Day |
2019 | Year | 04 | Month | 30 | Day |
2019 | Year | 04 | Month | 30 | Day |
2013 | Year | 07 | Month | 10 | Day |
2019 | Year | 02 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013076
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