Study of NAC of GA Therapy for Patients With BRPC

Study Overview
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Brief Summary
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Gemcitabine plus nub-paclitaxel (GA) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy on survival time as a preoperative chemotherapy, the investigators use the NAC-GA regimen includes only two cycles (three times weekly and one week rest) of GA regimen.

Detailed Description
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Gemcitabine plus nub-paclitaxel (GA) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. GA is one of the high response rate treatment regimen, the investigators considered as a promising treatment as neoadjuvant chemotherapy. On the other hand, incidences of grade 3 or 4 neutropenia, febrile neutropenia and peripheral neuropathy were significantly higher in the g group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy on survival time as a preoperative chemotherapy, the investigators use the NAC-GA regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen. The investigators also evaluate Recurrence free survival from the first day of protocol therapy, safety of the protocol therapy(Adverse effect), morbidity based on Clavien Dindo classification of more than Grade 3, response rate, preoperative/postoperative tumor marker (CA19-9, CEA), rate of mornalization, reduction rate of SUVmax value on PET-CT (limited only for PET-CT available institutions), chemotherapeutic effect grade based on Evans classification, resection rate, R0 resection rate, surgical data (operative time, blood loss, transfusion, postoperative hospital day), the overall morbidity rates (Reoperation, rate of re-admission, mortality), number of patient rate in postoperative adjuvant therapy (entry rate, completion rate), dose intensity for borderline resectable pancreatic cancer.

Official Title
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Phase II Study of Neoadjuvant Chemotherapy of Gemcitabine+Nab-paclitaxel Therapy for Patients With Borderline Resectable Pancreatic Cancer

Conditions
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Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Drug: Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically diagnosed as pancreatic adenocarcinoma, and consistent with NCCN guideline (Version 2. 2016) borderline resectable-arterial, borderline resectable-venous Case with measurable lesion First line treatment PS (ECOG) 0-1 >= 20 years old and <80 years old The following criteria must be satisfied in laboratory tests within 14 days of registration WBC count<=12,000/mm3 Neutrophil count>=1,500/mm3 Hb >= 9.0g/dl Plt >= 100,000/mm3 T.Bil <2.0mg/dl (<3=.0mg/dl in biliary drainage case) Serum Cr<=upper limits of normal (ULN) AST, ALT <= 2.5xULN Written informed consent to participate in this study Exclusion Criteria: Severe drug hypersensitivity Multiple primary cancers within 5 years Severe infection With grade2 or more severe peripheral neuropathy Interstitial pneumonia or pulmonary fibrosis With uncontrollable pleural effusion or ascites With uncontrollable diabetes mellitus With uncontrollable heart failure, angina, hypertension, arrhythmia With severe neurological/psychological symptoms With watery diarrhea Pregnant or lactating women or women with unknown or suspected pregnancy Inappropriate patients for entry on this study in the judgement of the investigator Diagnosed as Resectable/Unresectable pancreatic carcinoma on NCCN guideline (Version 2.2016)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine plus nab-paclitaxel<br>Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel: Enrolled patients were administered a 30-min intravenous infusion of nab-paclitaxel at a dose of 125 mg/m2, followed by a 30-min intravenous infusion of gemcitabine at a dose of 1000 mg/m2, on day 1, 8, and 15 evey 4 weeks as one cycle of regimen. | Drug: Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel<br>* Enrolled patients were administered a 30-min intravenous infusion of nab-paclitaxel at a dose of 125 mg/m2, followed by a 30-min intravenous infusion of gemcitabine at a dose of 1000 mg/m2, on day 1, 8, and 15 evey 4 weeks as one cycle of regimen.<br>* Other names: NAC-GA for BRPC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival time from the first day of protocol therapy |  | Up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival from the first day of protocol therapy |  | Up to 60 months | 
| Adverse effect | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | Up to 30 weeks | 
| Morbidity based on Clavien Dindo classification of more than Grade3 |  | Up to 30 weeks | 
| Response rate |  | Up to 12 weeks | 
| Chemotherapeutic effect grade based on Evans classification |  | Up to 12 weeks | 
| Resection rate |  | Up to 30 weeks | 
| R0 resection rate |  | Up to 30 weeks | 
| Intraoperative blood loss |  | Up to 30 weeks | 
| The overall morbidity rates based on Clavien Dindo classification |  | Up to 50 weeks | 
| Number of patient rate in postoperative adjuvant therapy |  | Up to 30 weeks | 
| Dose intensity |  | Up to 12 weeks |