Unique ID issued by UMIN | UMIN000048555 |
---|---|
Receipt number | R000055315 |
Scientific Title | Neoadjuvant Gemcitabine+nab-Paclitaxel for resectable and borderline resectable pancreatic cancer-feasibility study for the elderly |
Date of disclosure of the study information | 2022/08/10 |
Last modified on | 2023/02/03 13:21:14 |
Neoadjuvant Gemcitabine+nab-Paclitaxel for resectable and borderline resectable pancreatic cancer-feasibility study for the elderly
GANAC-PE study
Neoadjuvant Gemcitabine+nab-Paclitaxel for resectable and borderline resectable pancreatic cancer-feasibility study for the elderly
GANAC-PE study
Japan |
Resectable and Borderline resectable pancreatic cancer
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To examine efficacy, safety and feasibility of neoadjuvant Gemcitabine + nab-Paclitaxel for resectable and borderline resectable pancreatic cancer, especially in a population of the elderly
Safety,Efficacy
Phase II
3-year recurrence-free survival
3-year overall survival
completion rate, adverse events and surgical outcomes, etc
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Neoadjuvant chemotherapy
Gemcitabine 1000mg/m2+nabPaclitaxel 125mg/m2
1/week for 3 weeks, 1-week rest
20 | years-old | <= |
90 | years-old | > |
Male and Female
Histologically proven resectable and borderline resectable pancreatic cancer
1) Patients with active multiple cancer lesions
2) Patients with any history of serious allergic reaction
3) Patients with serious comorbidity (Infectious, respiratory, cardiac, kidney and liver diseases)
4) Patients who are judged as inappropriate research subjects
50
1st name | Yasuyuki |
Middle name | |
Last name | Suzuki |
Hyogo Prefectural Awaji Medical Center
Surgery
656-0021
1-1-137 Shioya, Sumoto, Hyogo
0799221200
szk@awajimc.jp
1st name | Yasuyuki |
Middle name | |
Last name | Suzuki |
Hyogo Prefectural Awaji Medical Center
Surgery
656-0021
1-1-137 Shioya, Sumoto, Hyogo
0799221200
szk@awajimc.jp
Hyogo Prefectural Awaji Medical Center
Hyogo Prefectural Awaji Medical Center
Local Government
IRB, Hyogo Prefectural Awaji Medical Center
1-1-137 Shioya, Sumoto, Hyogo
0799221200
Awaji_hos@pref.hyogo.lg.jp
NO
2022 | Year | 08 | Month | 10 | Day |
Unpublished
Preinitiation
2022 | Year | 06 | Month | 01 | Day |
2022 | Year | 07 | Month | 01 | Day |
2022 | Year | 08 | Month | 10 | Day |
2030 | Year | 06 | Month | 30 | Day |
2022 | Year | 08 | Month | 02 | Day |
2023 | Year | 02 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055315
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