Table 1.
Inclusion criteria | Exclusion criteria |
---|---|
Histological evidence of locally advanced pancreatic cancer or small volume metastasis not amenable to systemic chemotherapy and surgical resection, if the patient is unfit or refuses surgical resection | Evidence of metastasis other than to lung or liver. If metastasis in the lung or liver, lesions must be <5 cm in diameter |
Age >18 years | Age <18 years, pregnancy, breast feeding, or porphyria |
Measurable tumor as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria | Locally advanced disease with more than 50% of the circumference of the duodenum involved or involvement of a major artery |
ECOG performance stage 0–2 | ECOG performance status 3–4 |
Estimated life expectancy of at least 12 weeks | Prior treatment with curative intent within the past 12 weeks before entry |
Capable of giving informed consent | Any psychiatric condition that makes informed consent impossible |
Adequate biliary drainage with total bilirubin <2.5 times the upper limit of normal | Documented hemorrhagic diathesis or coagulopathy, need for therapeutic anticoagulation, history of additional past or current malignancy that would interfere with treatment response evaluation |
Women of childbearing age require a negative pregnancy test before study and must remain on contraception for the duration of the study | Evidence of uncontrolled systemic disease or laboratory finding that would in the investigator’s opinion undesirable for the patient to participate in the trial |