Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: Phase I Study of Neoadjuvant Chemotherapy for Patients With Borderline Resectable Pancreatic Cancer.

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.

Eligibility: 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

Relevance to patient case: not relevant