Unique ID issued by UMIN | UMIN000012975 |
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Receipt number | R000015149 |
Scientific Title | A I/II phase study of chemotherapy using irinotecan plus L-OHP plus S-1 treatment (SOXIRI) for unresectable advanced pancreatic cancer |
Date of disclosure of the study information | 2014/01/27 |
Last modified on | 2014/01/27 16:04:36 |
A I/II phase study of chemotherapy using irinotecan plus L-OHP plus S-1 treatment (SOXIRI) for unresectable advanced pancreatic cancer
A phase I/II study of chemotherapy(SOXIRI)
A I/II phase study of chemotherapy using irinotecan plus L-OHP plus S-1 treatment (SOXIRI) for unresectable advanced pancreatic cancer
A phase I/II study of chemotherapy(SOXIRI)
Japan |
unresectable advanced pancreatic cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
Exploring for SOXIRI of MTD and DLT and RD.
Efficacy
MTD and DLT and RD
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Irinotecan is administered with 90 min intravenous infusion on day 1,15 every 4 weeks.
L-OHP is administered with 120 min intravenous infusion on day 1,15 every 4 weeks.
S-1 is taken orally on day 1-14 every 4 weeks.20
20 | years-old | <= |
80 | years-old | > |
Male and Female
(1)unresectable invasive or reccurence advanced pancraatic carcinoma
(2)first line treatment
(3)Patients must be >=20 years old and <=80 years old
(4)ECOG Performance Status must be 0 or 1.
(5)The following criteria must be satisfied in laboratory tests.
1) Hemoglobin >= 9.0 g/dL
2) White blood cell count >=3,000/mm3
,Neutrophil count >=1,500/mm3
3)Platelet count >=75,000mm3
4)Total bilirubin <=one and a half times as many as average level baseline
5)AST,ALT,ALP<= two and a half times as many as average level baseline
6) Serum Creatinine <=average level baseline
(6)Life expectancy > 90 days.
(7)Patients or legal representative must have signed the consent form.
(1) infusion of blood products within 7days
(2) not first line treatment
(3) severe Allergie
(4) much ascites or pleural effusion
(5) infection
(6) diarrea
(7) ileus
(8) neuropathy
(9) severe heart disorder
(10) neuropsychiatric disorder
(11) idiopathic pulmonary fibrosis or Idiopathic interstitial pneumonia
(12) brain metastasis
(13) pregnancy case
(14) unsuitable case
30
1st name | |
Middle name | |
Last name | Takayama tetsuji |
the univercity of tokushima
department of gastroenterology
3-18-15 kuramoto town tokushima city
088-633-9116
takayama@tokushima-u.ac.jp
1st name | |
Middle name | |
Last name | takayama tetsuji |
the university of tokushima
department of gastroenterology
3-18-15 kuramoto town tokushima city
088-633-9116
takayama@tokushima-u.ac.jp
the university of tokushima
the university of tokushima
Self funding
NO
2014 | Year | 01 | Month | 27 | Day |
Unpublished
Open public recruiting
2014 | Year | 01 | Month | 27 | Day |
2014 | Year | 01 | Month | 27 | Day |
2014 | Year | 01 | Month | 27 | Day |
2014 | Year | 01 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015149
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