Pancreatic Cancer
Conditions
Brief summary
Gemcitabine plus nub-paclitaxel (GEMABR) 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 as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen.
Detailed description
Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. GEMABR 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 as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen. The investigators also evaluate the optimal treatment schedule of NAC-GEMABR therapy as neoadjuvant chemotherapy, optimal duration between surgery and chemotherapy, R0 resection rate, and resection rate for borderline resectable pancreatic cancer.
Interventions
DRUGNAC-GEMABR
NAC-GEMABR regimen includes gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 3 times weekly 1week rest.
Sponsors
Wakayama Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically proven invasive pancreatic ductal carcinoma * Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2) 1. Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma 2. Patients indicated distal pancreatectomy with en bloc celiac axis resection * PS (ECOG) 0-1 * ≧20 years old and \< 80 years old * First line treatment * The following criteria must be satisfied in laboratory tests within 14 days of registration White blood cell count ≦12,000/mm3 Neutrophil count ≧1,500/mm3 Platelet count ≧100,000mm3 Total bilirubin \<2.0mg/dL Serum Creatinine ≦upper limits of normal(ULN) AST, ALT≦2.5×ULN Albumin≧3.0g/dL Hemoglobin≧9.0g/dL * 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 * With intestinal paralysys, ileus * Interstitial pneumonia or pulmonary * With uncontrollable pleural effusion or ascites * Receiving atazanavir sulfate * With uncontrollable diabetes * With uncontrollable heart failure, angina, hypertension, arrhythmia * With severe psychological symptoms * With watery diarrhea * Pregnant or lactating women, or women with known or suspected pregnancy * Inappropriate patients for entry on this study in the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with toxicity of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. | Up to 30 weeks. | Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0. |
Secondary
| Measure | Time frame |
|---|---|
| The resection rate of NAC-GEMABR therapy as neoadjuvant chemothterapy for borderline resectable pancreatic cancer. | Up to 24 weeks |
| The R0 resection rate of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. | Up to 30 weeks |
Countries
Japan
Contacts
Primary ContactHiroki Yamaue, M.D., PhD
Outcome results
None listed