A Phase 2 Study of 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