Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer

This trial is designed to find the maximum tolerated dose of radiation under a fixed
5-fraction SBRT regimen escalating the dose from 40 Gy in 5 fractions, to 60 Gy in 5
fractions, at 5 Gy intervals.

Inclusion Criteria:

- Diagnosis: Histologically-proven invasive adenocarcinoma of the pancreas.

- Disease Status: Medically unresectable (any stage), or locally advanced (stage III).

- Tumor Location: Primary tumor may be located anywhere in the pancreas.

- Treatment eligibility: The patient must be able to have fiducial markers implanted
into the pancreatic tumor, and receive radiation regimen as specified in the
protocol.

- Performance Level: Karnofsky Performance Status ≥ 60

- Adequate Renal Function Defined As: Serum creatinine ≤ 1.5 x upper limit of normal

- Informed Consent: All subjects must sign a written informed consent.

Exclusion Criteria:

- Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on
this study due to risks of fetal and teratogenic adverse events. (Note: Serum
Pregnancy tests must be obtained in women of child bearing potential). Sexually
active females may not participate unless they have agreed to use an effective
contraceptive method (such as abstinence, diaphragm, condom, or intrauterine device)
to prevent pregnancy for the duration of the study.

- Life expectancy < 6 months

- The patient cannot have had prior radiation therapy to the thorax or upper abdomen.

- Incarcerated individuals

- Subjects unable to give informed consent