Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer

Phase I Trial of Adaptive Stereotactic Body Radiotherapy (SBRT) Dose Escalation in Pancreatic Cancer

This study is to determine the maximum tolerated dose (MTD) of five fraction stereotactic radiotherapy (SBRT) 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