A Study of Chemoradiotherapy Using Gem Plus Nab-paclitaxel for Pancreatic Cancer

Study Overview
=================
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 locally advanced pancreatic adenocarcinoma.

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 toxicity. Gemcitabine plus nab-Paclitaxel is a promising regimen for concurrent chemoradiotherapy, but the investigators need to know the safety in the case of the concurrent chemoradiotherapy.

Official Title
-----------------
A Phase I Study of Chemoradiotherapy Using Gemcitabine Plus Nab-paclitaxel for Unresectable Locally Advanced Pancreatic Adenocarcinoma

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine
* Drug: Nab-Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine, Nab-Paclitaxel<br>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. | Drug: Gemcitabine<br>* Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.<br>* Other names: Gemcitabine ；gemzer;Drug: Nab-Paclitaxel<br>* Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.<br>* Other names: Nab-Paclitaxel ；Abraxane;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Adverse Events |  | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | 1 years | 
| Overall Survival time |  | 2 years |