Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

Inclusion Criteria:

• Patients with resectable pancreatic adenocarcinoma
• Age over 18 years old and younger than 70 year old
• Performance status (ECOG scale): 0-1

• Adequate organ functions

  • Hb ≥9.0 g/dl
  • ANC ≥1,500/mm3
  • PLT ≥100,000/mm3
  • Liver function: Total Bilirubin ≤3.0 mg/dl AST/ALT/ALP ≤3× upper limit of normal
  • Creatinine ≤1.5 ULN
• Patients should sign a written informed consent before study entry.

Exclusion Criteria:

• Tumor type other than adenocarcinoma
• Unresectable for resection on preoperative evaluation
• Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
• Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy)
• Prior radiotherapy
• Major surgery within 4 weeks prior to study treatment

• Serious illness or medical conditions, as follows;

  • congestive heart failure (NYHA class III or IV)
  • unstable angina or myocardial infarction within the past 6 months,
  • significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
  • uncontrolled hypertension
  • hepatic cirrhosis( ≥ Child class B)
  • interstitial pneumonia, pulmonary adenomatosis
  • psychiatric disorder that may interfere with and/or protocol compliance
  • unstable diabetes mellitus
  • uncontrolled ascites or pleural effusion
  • active infection
• Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug
• Pregnant or lactating woman
• Women of child bearing potential not using a contraceptive method
• Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
• Any patients judged by the investigator to be unfit to participate in the study