Unique ID issued by UMIN | UMIN000013385 |
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Receipt number | R000015616 |
Scientific Title | PhaseII study of 5-FU/I-LV+L-OHP+CPT-11 combination chemotherapy(FOLFIRINOX) in 1st line treatment for locally advanced pancreatic cancer |
Date of disclosure of the study information | 2014/03/10 |
Last modified on | 2019/06/21 09:21:13 |
PhaseII study of 5-FU/I-LV+L-OHP+CPT-11 combination chemotherapy(FOLFIRINOX) in 1st line treatment for locally advanced pancreatic cancer
FOLFIRINOX
PhaseII study of 5-FU/I-LV+L-OHP+CPT-11 combination chemotherapy(FOLFIRINOX) in 1st line treatment for locally advanced pancreatic cancer
FOLFIRINOX
Japan |
locally advanced pancreatic cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
Evaluation of the efficacy and safety of 5-FU/I-LV+L-OHP+CPT-11 combination chemotherapy(FOLFIRINOX) in 1st line treatment for locally advanced pancreatic cancer
Safety,Efficacy
Phase II
1 year survival rate
Progression free survival (PFS), Overall survival (OS), Response Rate (RR), Incidence of adverse events, Incidence of grade 3/4 adverse events, R0 resection rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
L-OHP; 85mg/m2 administration on day1, LV; 400mg/m2 administration on day1, CPT-11; 180mg/m2 administration on day1, 5-FU bolus; 400mg/m2 administration on day1, 5-FU 46h infusion; 2400mg/m2 administration on day1 46hour
One course lasts 2 weeks (14 days)
Not applicable |
75 | years-old | >= |
Male and Female
1)Histology from pancreatic mass and image diagnosis are suitable for adenocarcinoma; papillary, tubular, poorly, adenosquamous. There is no distant metastasis.
2)Unresectable locally advanced pancreatic cancer(a definition; NCCN guide line Version 1.2014)
3)Age under 75
4)PS(ECOG) between 0 and 1
5)No previous surgical resection, radiation and chemotherapy for pancreatic cancer
6)No previous therapy for other cancer within 5 years(exept for endoscopic surgery)
7)with a good condition of important organs within 14 days of registration
1. neutrophil>=1,500/mm3
2. hemoglobin>=9.0g/dL
3. platelet>=100,000/mm3
4. Albumin>=3.0g/dL
5. total bilirubin<=upper limits of normal(ULN)
6. AST<=2.5 x ULN
7. AST<=2.5 x ULN
8. serum creatinine<=1.2mg/dL
8)written informed consent to participate in this study
1)with pulmonary fibrosis or interstital pneumonia which can be detected from X-ray incontrovertibly or has clinical symptom
2)with severe diarrhea within 3 days before entry
3)with other severe diseases(heart failure, renal disfunction, liver disfunction, intestinal paralysys, ileus, uncontrolled DM)
4)patients whom administered flucitosine or Fenitoin or Warfarin
5)with active double cancers whose disease free period is shorter than 5 years Carcinoma in situ can be excluded.
6)with infectious disease which needs therapy
7)with body temperature over 38 degrees Celsius
8)women who are pregnant or expect to be pregnant, or nursing female
9)patients whom doctor in chief decides not to register to this study due to psychological disease or symptoms
10)general administration of steroids
11)with grade 2 or more severe peripheral neuropathy
12)with UGT1A1*28 and/or UGT1A1*6 polymorphisms
45
1st name | |
Middle name | |
Last name | Masahiro Goto |
Osaka Medical College Hospital
Cancer Chemotherapy Center
2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
072-683-1221
in2030@poh.osaka-med.ac.jp
1st name | |
Middle name | |
Last name | Masahiro Goto |
Osaka Medical College Hospital
Cancer Chemotherapy Center
2-7, Daigaku-machi, Takatsuki City, Osaka, JAPAN
072-683-1221
in2030@poh.osaka-med.ac.jp
Osaka Medical College Hospital
Osaka Medical College Hospital
Self funding
Japan
NO
大阪医科大学附属病院
2014 | Year | 03 | Month | 10 | Day |
Unpublished
Completed
2014 | Year | 03 | Month | 04 | Day |
2016 | Year | 03 | Month | 03 | Day |
2014 | Year | 04 | Month | 01 | Day |
2017 | Year | 02 | Month | 28 | Day |
2014 | Year | 03 | Month | 10 | Day |
2019 | Year | 06 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015616
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