Unique ID issued by UMIN | UMIN000013217 |
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Receipt number | R000015423 |
Scientific Title | Feasibility study of FOLFIRINOX as first-line chemotherapy for metastatic pancreatic cancer |
Date of disclosure of the study information | 2014/02/25 |
Last modified on | 2023/03/01 10:29:41 |
Feasibility study of FOLFIRINOX as first-line chemotherapy for metastatic pancreatic cancer
KOBE FOLFIRINOX study
Feasibility study of FOLFIRINOX as first-line chemotherapy for metastatic pancreatic cancer
KOBE FOLFIRINOX study
Japan |
pancreatic cancer
Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Malignancy
NO
Determining the maximum tolerated dose (MTD) and recommended dose (RD)
Safety,Efficacy
Exploratory
Phase I
Proportion of dose limiting toxicity
safety (adverse event, completion rate), efficacy (overall survival, progression free survival, response rate)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
FOLFIRINOX
18 | years-old | <= |
Not applicable |
Male and Female
1) Unresectable metastatic or recurrence pancreatic cancer
2) Histlogically proven adenocarcinoma
3) Age >= 18 years
4) ECOG performance status of 0, 1
5) Previous 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) diarrhea greater than Grade 2
11) ileus
12) massive pleural effusion,ascites
13) history for allergy of L-OHP,CPT-11,5-FU,L-LV,bevacizumab
18
1st name | Hisateru |
Middle name | |
Last name | Yasui |
Kobe City Medical Center General Hospital
medical oncology
650-0047
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
0783024321
hyasui@kcho.jp
1st name | Hisateru |
Middle name | |
Last name | Yasui |
Kobe City Medical Center General Hospital
medical oncology
650-0047
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
0783024321
hyasui@kcho.jp
Kobe City Medical Center General Hospital
Kobe City Medical Center General Hospital
Local Government
Kobe City Medical Center General Hospital
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
0783024321
ctc-crc@kcho.jp
NO
神戸市立医療センター中央市民病院(兵庫県)
2014 | Year | 02 | Month | 25 | Day |
Unpublished
Completed
2014 | Year | 02 | Month | 10 | Day |
2014 | Year | 02 | Month | 10 | Day |
2014 | Year | 02 | Month | 25 | 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 | 02 | Month | 21 | Day |
2023 | Year | 03 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015423
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