Unique ID issued by UMIN | UMIN000012254 |
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Receipt number | R000013500 |
Scientific Title | A phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic adenocarcinoma |
Date of disclosure of the study information | 2013/11/09 |
Last modified on | 2018/11/12 11:32:17 |
A phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic adenocarcinoma
A phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic adenocarcinoma
A phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic adenocarcinoma
A phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic adenocarcinoma
Japan |
Unresectable locally advanced pancreatic adenocarcinoma
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the clinical safety and efficacy of Gemcitabine plus nab-Paclitaxel chemoradiotherapy and to determine the MTD for unresectable locally advanced pancreatic adenocarcinoma
Safety
Exploratory
Pragmatic
Phase I
Safety
Response Rate, Overall Survival time, Palliative efficacy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Medicine |
Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Concurrent radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions.
20 | years-old | <= |
75 | years-old | > |
Male and Female
1.Histologically or cytologically confirmed advanced pancreatic cancer
2.Locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery)
3.Performance Status:0-1(ECOG)
4.Patients of age =>20 and 75>
5.WBC>=3,500/mm3,12,000/mm3,
neutrophils >=1,500/mm3, platelets=100,000/mm3,
hemoglobin >=9.5 g/dl,
GOT </=2.0 X ULN,
GPT </=2.0 X ULN,
AL-P </=2.0 X ULN,
total bilirubin <=1.5mg/dl,
serum creatinine <=1.2mg/dl,
creatinine clearance>=50 ml/min,
PaO2 >=70torr or SpO2 >=96%
6.Life expectancy more than 3 months.
7.Written informed consent.
1.Active infection
2.Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT
3.Severe complication (heart disease, cirrhosis, diabetes)
4.Myocardial infarction within 3 months
5.Active synchronous or metachronous malignancy
6.Pregnant or lactation women, or women with known or suspected pregnancy 7.Symptomatic brain metastasis
8.history of severe drug allergy
9.Peripheral neuropathy
10.Patients who are judged inappropriate for the entry into the study by the investigator
54
1st name | |
Middle name | |
Last name | Tatsuya Ioka |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division of Hepatobiliary and Pancreatic Oncology
3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
06-6972-1181
ioka-ta@mc.pref.osaka.jp
1st name | |
Middle name | |
Last name | Tatsuya Ioka |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division of Hepatobiliary and Pancreatic Oncology
3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
06-6972-1181
ioka-ta@mc.pref.osaka.jp
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division of Hepatobiliary and Pancreatic Oncology
Osaka foundation for the prevention of cancer and cardiovascular diseases
Non profit foundation
Japan
NO
大阪府立成人病センター(大阪府)
2013 | Year | 11 | Month | 09 | Day |
Partially published
No longer recruiting
2013 | Year | 07 | Month | 01 | Day |
2013 | Year | 08 | Month | 31 | Day |
2017 | Year | 12 | Month | 31 | Day |
2017 | Year | 12 | Month | 31 | Day |
2018 | Year | 01 | Month | 31 | Day |
2013 | Year | 11 | Month | 08 | Day |
2018 | Year | 11 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013500
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