Neoadjuvant FDR GX in Locally Advanced Pancreatic Cancer

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, neoadjuvant chemotherapy, gemcitabine, capecitabine Read More

Inclusion Criteria:

• Histologically or cytologically documented pancreatic adenocarcinoma
• Clinical T3 or T4 tumor according to AJCC staging system
• Tumors considered as borderline resectable or unresectable disease assessed by multidisciplinary team including pancreatic surgeon, gastroenterologist specializing in pancreas, medical oncologist, and radiation oncologist
• Age 18 years or older
• ECOG performance status 2 or less

• Adequate organ function

  • Adequate bone marrow function (WBCs> 3,500/µL, absolute neutrophil count [ANC]> 1,500/µL, hemoglobin > 9.0 g/dL, and platelets > 100,000/µL)
  • Adequate kidney function (creatinine < 1.5 mg/dL)
  • Adequate liver function (bilirubin < 1.5 mg/dL [<2.5 mg/dL for patients with obstructive jaundice due to pancreatic cancer with adequate decompression], transaminases levels < 3 times the upper normal limit)
• Patients must not have psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with this study
• Women of childbearing potential must have a negative pregnancy test on admission. Post-menopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Men and women of reproductive potential must have agreed to use an effective method of contraception while on treatment and for 6 months after study treatment
• The patient must be able to understand the study and has given written informed consent to participate in the study

Exclusion Criteria:

• Other tumor type than adenocarcinoma
• Evidence of gastrointestinal bleeding or obstruction
• Presence of the clinically relevant ascites or distant metastases
• Past or concurrent history of malignant neoplasm, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
• Pregnant or lactating women, women of childbearing potential not employing adequate contraception
• Hypersensitivity to any of the study drugs or ingredients

• Other serious illness or medical conditions

  • Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
  • History of significant neurologic or psychiatric disorders including dementia or seizures
  • Active uncontrolled infection
  • Pre-existing clinically significant diarrhea
  • Active peptic ulcer
  • Severe hypercalcemia of 12 mg/dL uncontrolled with bisphosphonates
  • Active disseminated intravascular coagulation
  • Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
• Concomitant or administration of any other experimental drug under investigation within 3 weeks before the study
• Concomitant chemotherapy, hormonal therapy, or immunotherapy