Unique ID issued by UMIN | UMIN000012991 |
---|---|
Receipt number | R000015170 |
Scientific Title | Japanese phase I study of TRIplet + BEvacizumab for metastatic colorectal cancer. |
Date of disclosure of the study information | 2014/01/28 |
Last modified on | 2017/09/20 02:04:50 |
Japanese phase I study of TRIplet + BEvacizumab for metastatic colorectal cancer.
JI-TRIBE study
Japanese phase I study of TRIplet + BEvacizumab for metastatic colorectal cancer.
JI-TRIBE study
Japan |
Colorectal cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
Determining the maximum tolerable dose(MTD) and recomended dose(RD)
Safety
Exploratory
Phase I
Proportion of dose limiting toxicity
safety(adverse event,completion rate),efficacy(overall survival,progression free survival,responserate)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
5FU
Leucovorin
Irinotecan
Oxaliplatin
bevacizumab
20 | years-old | <= |
Not applicable |
Male and Female
1) Unresectable metastatic or recurrence colorectal cancer
2) Histlogically proven colorectal carcinoma
3) Age >= 18 years
4) ECOG performance status of 0, 1
5) Previous L-OHP based adjuvant chemotherapy was allowed if relapsed more than 6 months after last administration
6) UGT1A1*6*28 wild type or single hetero
7) No prior chemotherapy and radiotherapy for other malignancies
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
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,ascites
12) history for allergy of L-OHP,CPT-11,5-FU,L-LV,bevacizumab
18
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
hsatake@kcho.jp
Kobe City Medical Center General Hospital
Kobe City Medical Center General Hospital
Local Government
NO
神戸市立医療センター中央市民病院(兵庫県)
2014 | Year | 01 | Month | 28 | Day |
Partially published
http://www.sciencedirect.com/science/article/pii/S2213089615000195
Completed
2014 | Year | 01 | Month | 21 | Day |
2014 | Year | 01 | Month | 28 | Day |
2015 | Year | 07 | Month | 31 | Day |
2016 | Year | 07 | Month | 31 | Day |
2016 | Year | 07 | Month | 31 | Day |
2016 | Year | 07 | Month | 31 | Day |
2014 | Year | 01 | Month | 28 | Day |
2017 | Year | 09 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015170
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |