This phase I trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with pancreatic cancer that cannot be removed by surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02454140.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of stereotactic body radiotherapy (stereotactic body radiation therapy) (SBRT) in pancreatic cancer.
SECONDARY OBJECTIVES:
I. To estimate the rate of local tumor progression after SBRT.
II. To estimate the rate of distant disease progression after SBRT.
III. To measure overall survival after SBRT.
IV. To estimate a dose-response between radiation dose and local control.
V. To measure longitudinal quality of life before and after SBRT.
VI. To determine the correlation between quality of life, and disease progression after SBRT.
VII. To determine if any dose-volume parameters predict grade >= 3 duodenal toxicity.
VIII. To determine if patients are able to receive additional chemotherapy after SBRT.
IX. To identify natural anatomical surrogates that best correlate with the motion of the fiducial markers.
X. To determine if adaptive radiation therapy (RT) would be beneficial.
OUTLINE: This is a dose-escalation study.
Patients undergo stereotactic body radiation therapy once daily (QD) on days 1-5.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months thereafter.
Lead OrganizationUC San Diego Medical Center - Hillcrest
Principal InvestigatorJames D. Murphy
