A Study of Chemoradiotherapy Using Gem Plus Nab-paclitaxel for Pancreatic Cancer
NCT ID: NCT02272738
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
54 participants
INTERVENTIONAL
2013-08-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gemcitabine, Nab-Paclitaxel
A conformal phase I study using 3 plus 3 method.
Chemoradiotherapy while Gemcitabine, Nab-Paclitaxel are administered.
Both Gemcitabine and Nab-Paclitaxel are an interventional agents in this arm.
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.
Radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions.
Gemcitabine
Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Nab-Paclitaxel
Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Interventions
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Gemcitabine
Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Nab-Paclitaxel
Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
20 Years
75 Years
ALL
No
Sponsors
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Osaka Medical Center for Cancer and Cardiovascular Diseases
OTHER
Responsible Party
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Principal Investigators
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Tatsuya Ioka, MD
Role: STUDY_DIRECTOR
Osaka Medical Center for Cancer and Cardiovascular Diseases
Locations
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Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, , Japan
Countries
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Other Identifiers
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UMIN 000012254
Identifier Type: REGISTRY
Identifier Source: secondary_id
TatsuyaIoka2013
Identifier Type: -
Identifier Source: org_study_id
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