Status:
COMPLETED
A Study of Chemoradiotherapy Using Gem Plus Nab-paclitaxel for Pancreatic Cancer
Lead Sponsor:
Osaka Medical Center for Cancer and Cardiovascular Diseases
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine plus nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for unresectable locall...
Detailed Description
Gemcitabine plus nab-Paclitaxel is one of the standard chemotherapy for metastatic pancreatic adenocarcinoma. Gemcitabine plus nab-Paclitaxel realize the favorable anti-tumor effect and tolerable toxi...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed advanced pancreatic cancer
- Locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery)
- Performance Status:0-1(ECOG)
- Patients of age =\>20 and 75\>
- White Blood Cell (WBC) \>=3,500/mm3,12,000/mm3,
- Neutrophils \>=1,500/mm3, platelets=100,000/mm3,
- Hemoglobin \>=9.5 g/dl,
- GOT \</=2.0 X Upper Limit Number (ULN),
- Glutamate Pyruvate Transaminase (GPT) \</=2.0 X ULN,
- Alkaline Phosphatase (ALP) \</=2.0 X ULN,
- Total bilirubin \<=1.5mg/dl,
- Serum creatinine \<=1.2mg/dl,
- Creatinine clearance\>=50 ml/min
- arterial O2 pressure (PaO2) \>=70torr or arterial O2 saturation (SpO2) \>=96%
- Life expectancy more than 3 months.
- Written informed consent.
Exclusion
- Active infection
- Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT
- Severe complication (heart disease, cirrhosis, diabetes)
- Myocardial infarction within 3 months
- Active synchronous or metachronous malignancy
- Pregnant or lactation women, or women with known or suspected pregnancy
- Symptomatic brain metastasis
- History of severe drug allergy
- Peripheral neuropathy
- Patients who are judged inappropriate for the entry into the study by the investigator
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02272738
Start Date
August 1 2013
End Date
April 1 2016
Last Update
November 21 2017
Active Locations (1)
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1
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Japan, 537-8511