Unique ID issued by UMIN | UMIN000007875 |
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Receipt number | R000008356 |
Scientific Title | Prospective study for gemcitabine and S1 refractory pancreatic cancer with FOLFOX treatment |
Date of disclosure of the study information | 2012/05/01 |
Last modified on | 2017/10/03 10:41:00 |
Prospective study for gemcitabine and S1 refractory pancreatic cancer with FOLFOX treatment
FOLFOX for GEM/S1 refractory pancreatic cancer
Prospective study for gemcitabine and S1 refractory pancreatic cancer with FOLFOX treatment
FOLFOX for GEM/S1 refractory pancreatic cancer
Japan |
unresectable or recurrent pancreatic cancer
Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the feasibility and efficacy of modified FOLFOX6 therapy for unresectable or recurrent pancreatic cancer which is refractory for gemcitabine and S1
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Feasibility (treatment continuation rate for 3 course)
Overall survival
Response rate, Progression free survival, Adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
modified FOLFOX6 therapy against gemcitabine and S1 refractory pancreatic cancer
20 | years-old | <= |
Not applicable |
Male and Female
1. Histologically confirmed pancreatic adenocarcinoma
2. Unresectable or recurrent disease
3. Gemcitabine and S-1 refractory
4. Age over 20
5. ECOG PS=0, 1, 2
6. Life expectancy over 12 weeks
7. Well controlled sympton
8. Needs adequate organ function
9. Written informed consent
1. Uncontrollable diarrhea
2. Administration of phenytoin, warfarin, flucytosine
3. Pleural effusion, Ascites
4. Active serious infection
5. Active multiple cancer
6. Active peptic ulcer
7. Serious complication
8. Serious mental disorder
9. Serious drug allergy
10. Pregnancy woman, or woman with suspected pregnancy
11. Any subject judged by the investigator to be unfit for any reason to participate in the study
20
1st name | |
Middle name | |
Last name | Fuyuhiko Motoi |
Tohoku University Hospital
Division of hepato-biliary pancreatic surgery
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
022-717-7205
fmotoi@surg1.med.tohoku.ac.jp
1st name | |
Middle name | |
Last name | Fuyuhiko Motoi |
Tohoku University Hospital
Division of hepato-biliary pancreatic surgery
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
022-717-7205
http://www.surg1.med.tohoku.ac.jp/
fmotoi@surg1.med.tohoku.ac.jp
Division of hepato-biliary pancreatic surgery, Tohoku University (Graduate School of Medicine)
Division of hepato-biliary pancreatic surgery, Tohoku University (Graduate School of Medicine)
Self funding
NO
2012 | Year | 05 | Month | 01 | Day |
Unpublished
Completed
2012 | Year | 04 | Month | 17 | Day |
2012 | Year | 05 | Month | 01 | Day |
2016 | Year | 05 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2017 | Year | 10 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008356
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