Unique ID issued by UMIN | UMIN000022276 |
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Receipt number | R000025668 |
Scientific Title | A multicenter observational study of TAS-102 and regorafenib in patients with metastatic colorectal cancer |
Date of disclosure of the study information | 2016/05/12 |
Last modified on | 2016/11/14 14:57:17 |
A multicenter observational study of TAS-102 and regorafenib in patients with metastatic colorectal cancer
A multicenter observational study of TAS-102 and regorafenib in patients with metastatic colorectal cancer
A multicenter observational study of TAS-102 and regorafenib in patients with metastatic colorectal cancer
A multicenter observational study of TAS-102 and regorafenib in patients with metastatic colorectal cancer
Japan |
Metastatic colorectal cancer
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the efficacy and safety of TAS-102 and Regorafenib in patients with metastatic colorectal cancer
Safety,Efficacy
EuroQol 5 Dimension-5L (EQ5D-5L)
Quality-adjusted life year (QALY)
Incremental cost-utility ratio (ICUR)
Progression free survival (PFS)
Overall survival (OS)
Response rate (RR)
Disease control rate (DCR)
Safety
To investigate the reason for treatment selection
Analysis of factor what patients were unable to choose the treatment by themselves
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1. Histologically proven Adenocarcinoma
of colorectal cancer
2. Prior chemotherapy with more than two regimens
3. Written informed consent
4. Age under 20 years old at the time of informed consent
5. Patients are able to take medications orally.
1. Prior therapy with TAS-102 or regorafenib
2. Inappropriate for the study in the option of the investigator
50
1st name | |
Middle name | |
Last name | Shin Sasaki |
Omori Red Cross Hospital
Surgery
4-30-1, Chuo, Ota-ku, Tokyo
03-3775-3111
s-sasaki@omori.jrc.or.jp
1st name | |
Middle name | |
Last name | Ethics committee |
Omori Red Cross Hospital
Ethics committee
4-30-1, Chuo, Ota-ku, Tokyo
03-3775-3111
jinji@omori.jrc.or.jp
Omori Red Cross Hospital
None
Self funding
NO
2016 | Year | 05 | Month | 12 | Day |
Unpublished
2015 | Year | 08 | Month | 06 | Day |
2015 | Year | 10 | Month | 01 | Day |
according to the protocol
2016 | Year | 05 | Month | 11 | Day |
2016 | Year | 11 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025668
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