Unique ID issued by UMIN | UMIN000016595 |
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Receipt number | R000019258 |
Scientific Title | A feasibility study of the use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy for unresectable pancreatic cancer |
Date of disclosure of the study information | 2015/02/21 |
Last modified on | 2016/11/04 11:40:12 |
A feasibility study of the use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy for unresectable pancreatic cancer
A feasibility study of the use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy for unresectable pancreatic cancer
A feasibility study of the use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy for unresectable pancreatic cancer
A feasibility study of the use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy for unresectable pancreatic cancer
Japan |
unresectable pancreatic cancer
Gastroenterology | Hepato-biliary-pancreatic surgery | Adult |
Malignancy
NO
To evaluate the feasibility of the use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy for unresectable pancreatic cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase II
relative dose indensity
neutropenia, febrile neutropenia, other adverse events(anemia, thrombocytopenia, anorexia, nausea, vommiting, diarrhea, peripheral sensory neuropathy), treatment cycles
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Prevention
Medicine |
The use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy
20 | years-old | <= |
Not applicable |
Male and Female
The inclusion criteria were: unresectable pancreatic cancer (locally advanced or metasitatic); an Eastern Cooperative Oncology Group PS of 0 or 1; adequate organ fuction (neutrophil count>2000/mm3, platelet count>10,000/mm3, total bilirubin <upper limit of normal*1.5); with written informed concent
Patients are excluded if they have received prior chemotherapy or radiation therapy (
except for adjuvant chemotherapy); UGT genetic polymorphisms of homozygous UGT1A1*28 or UGT1A1*6 or heterozygous UTG1A1*6 and UGT1A1*28; diarrrhea including water stools; active infection or other serious concomitant diseases.
40
1st name | |
Middle name | |
Last name | Yuichi Ando |
Nagoya University Hospital
Department of Clinical Oncology and Chemotherapy
65 Tsuruma-Cho, Showa-Ku, Nagoya, Japan
052-744-1903
yando@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Ayumu Matsuoka |
Nagoya University Hospital
Department of Clinical Oncology and Chemotherapy
65 Tsuruma-Cho, Showa-Ku, Nagoya, Japan
052-744-1903
ayumu0611@med.nagoya-u.ac.jp
Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
Management Expenses Grants
NO
2015 | Year | 02 | Month | 21 | Day |
Unpublished
2015 | Year | 02 | Month | 20 | Day |
2015 | Year | 04 | Month | 01 | Day |
2015 | Year | 02 | Month | 21 | Day |
2016 | Year | 11 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019258
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