Unique ID issued by UMIN | UMIN000011062 |
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Receipt number | R000012944 |
Scientific Title | Phase I study of neoadjuvant chemotherapy with gemcitabine and nab paclitaxel for resectable pancreatic cancer. |
Date of disclosure of the study information | 2013/07/01 |
Last modified on | 2021/01/03 12:34:51 |
Phase I study of neoadjuvant chemotherapy with gemcitabine and nab paclitaxel for resectable pancreatic cancer.
NAC with GEM+nab-PTX for pancreatic cancer
Phase I study of neoadjuvant chemotherapy with gemcitabine and nab paclitaxel for resectable pancreatic cancer.
NAC with GEM+nab-PTX for pancreatic cancer
Japan |
resectable pancreatic cancer
Hepato-biliary-pancreatic surgery |
Malignancy
NO
Optimal dose of GEM + nab-PTX combination therapy as preoperative chemotherapy for pancreatic cancer surgery patients and I see all the properties.
Safety
We can evaluate the sensitivity of anti-cancer drugs at a time when evaluable lesions prior to surgery. Prolongation of disease free survival and overall survival.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
dose escalation of nab-PTX
20 | years-old | <= |
80 | years-old | >= |
Male and Female
resectble pancreatic cancer patients withour serious complications
1) Patients with anti-cancer agent administration in history past
2) Active another cancer
3) Severe complications
4) Patients with interstitial pneumonia or pulmonary fibrosis
5) Active infection
6) Pregnant woman
7) Severe mental disorder
8) Others
18
1st name | Hidehiro |
Middle name | |
Last name | Tajima |
Kanazawa University Hospital
Hepato-Biliary-Pancreatic Surgery
920-8641
13-1 Takaramachi, Kanazawa
076-265-2362
hidetaji@staff.kanazawa-u.ac.jp
1st name | Hidehiro |
Middle name | |
Last name | Tajima |
Kanazawa University Hospital
Hepato-Biliary-Pancreatic Surgery
920-8641
13-1 Takaramachi Kanazawa
076-265-2362
crc.irb-knz@esct.jp
Department of Gastroenterological Surgery, Kanazawa University
None.
Other
JP
Department of Gastroenterological Surgery, Kanazawa University
13-1 Takaramachi
+81762362
hidetaji@staff.kanazawa-u.ac.jp
NO
2013 | Year | 07 | Month | 01 | Day |
https://www.spandidos-publications.com/10.3892/mco.2020.2188
Published
https://www.spandidos-publications.com/10.3892/mco.2020.2188
39
Dose-limiting toxicity (neutropenia, anemia, thrombocytopenia and / or hepatic disorder) was 44.4% (21 patients) of patients treated at level 1 and 60.0 of patients treated at dose level 2. Observed in% (18 patients). Therefore, the maximum withstand capacity was set to level 1. Six patients discontinued protocol treatment due to non-hematological adverse events (skin rash, pancreatitis, biliary tract infection). In conclusion, NAC with GnP was safe and viable for resectable PDAC at dose level 1.
2021 | Year | 01 | Month | 03 | Day |
Resectable pancreatic cancer patients
NAC and resection
See paper
NAC using GnP for resectable pancreatic cancer to determine the maximum tolerated dose of each drug
Completed
2013 | Year | 05 | Month | 20 | Day |
2013 | Year | 06 | Month | 01 | Day |
2013 | Year | 08 | Month | 01 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2013 | Year | 06 | Month | 28 | Day |
2021 | Year | 01 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012944
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