Unique ID issued by UMIN | UMIN000016630 |
---|---|
Receipt number | R000018969 |
Scientific Title | The phaseI,II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with locally-advanced pancreatic cancer |
Date of disclosure of the study information | 2015/02/25 |
Last modified on | 2022/09/02 17:58:31 |
The phaseI,II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with locally-advanced pancreatic cancer
GAS Study I/II
The phaseI,II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with locally-advanced pancreatic cancer
GAS Study I/II
Japan |
locally-advanced pancreatic cancer
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To investigate the safety and efficacy of gemcitabine+nab-paclitaxel+S-1(GAS)therapy as a neoadjuvant therapy for locally-advanced pancreatic cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
Phase I: incidence of adverse enent which apply for discontinuance criteria
Phase II: 2 year survival rate, median survival time
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
gemcitabine+nab-paclitaxel+S-1
gemcitabine
(Level I:800mg/m2)
(Level II:1000mg/m2)
nab-paclitaxel
(Level I:100mg/m2)
(Level II:125mg/m2)
S-1 (65mg/m2)
20 | years-old | <= |
80 | years-old | > |
Male and Female
(1)Histologically confirmed pancreatic cancer
(2)Locally advanced pancteatic cancer on imaging examinations
(3)Performance status(ECOG):0-1
(4)Initial therapy
(5)Agreement with signiture of aplicant has obtained before initiation of therapy
(1)severe allegy for medicine
(2)Patients with other malignant disease within 5 years
(3)Patients with active infection
(4)Patients with severe neuropathy(>Grade2)
(5)Patients with ileus
(6)Patients with interstitial pneumonia
(7)Patients with uncontrallable ascites or pleural fluid
(8)Patients with uncontrallable diabetes
(9)Patients with uncontrallable heart disease
(10)Patients with pregnant or possibly pregnant
(14)Patients who have judged not suitable for this study by doctor.
60
1st name | |
Middle name | |
Last name | Yoshiaki Murakami |
Hiroshima University
Institute of Biomedical and Health Sciences Applied Life Sciences Surgery
Kasumi,Minami-Ku, Hiroshima, JAPAN
082-257-5215
k-naru-surg@hiroshima-u.ac.jp
1st name | |
Middle name | |
Last name | Naru Kondo |
Hiroshima University
Institute of Biomedical and Health Sciences Applied Life Sciences Surgery
Kasumi,Minami-Ku, Hiroshima, JAPAN
082-257-5215
k-naru-surg@hiroshima-u.ac.jp
Hiroshima University
No
Other
NO
2015 | Year | 02 | Month | 25 | Day |
Unpublished
Completed
2015 | Year | 01 | Month | 10 | Day |
2015 | Year | 03 | Month | 25 | Day |
2015 | Year | 03 | Month | 27 | Day |
2021 | Year | 12 | Month | 31 | Day |
2021 | Year | 11 | Month | 30 | Day |
2015 | Year | 02 | Month | 25 | Day |
2022 | Year | 09 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018969