This phase I/II trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with pancreatic or ampulla of Vater 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 NCT01342354.
PRIMARY OBJECTIVES:
I. To assess the maximum tolerated dose (MTD) of delivering three fractions of stereotactic body radiation therapy (SBRT), and identify the appropriate dose for treatment of unresected carcinoma of the ampulla or pancreas.
SECONDARY OBJECTIVES:
I. Define toxicities, effect on pain score, and quality of life, the rate of post-treatment resectability, and local control (as measured by computed tomography [CT] or magnetic resonance imaging [MRI] and defined as lack of progressive disease by Response Evaluation Criteria in Solid Tumors [RECIST] criteria).
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients undergo SBRT delivered in 3 fractions over 1-2 hours over 8-10 days.
After completion of study treatment, patients are followed up at 1, 2, 4, 6, 9, and 12 months and then every 6 months thereafter.
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
Principal InvestigatorStanley Lawrence Liauw