PRIMARY OBJECTIVES:
I. To evaluate the efficacy of hypofractionated radiation therapy concurrently with zoledronic acid (Zometa) and fluorouracil (5Fu) or capecitabine.
SECONDARY OBJECTIVES:
I. To examine the toxicity of Zometa while it is used concurrently with hypofractionated radiation therapy.
II. To evaluate local failure-free survival and overall survival, surgical resection rate and tumor response rate.
TERTIARY OBJECTIVES:
I. To quantify the amplitude of the expression of genes that are involved in cholesterol biosynthesis (ACAT2, DHCR7, ELFN2, FASN, SC4MOL, and SQLE) in pancreatic tumor tissue prior to and following the Zometa and radiation therapy if the pancreatic cancer tissue is available.
II. To measure Zometa pharmacokinetics at steady-state. III. To evaluate tumor and organ motion with 4 dimension(D) computed tomography (CT) and respiratory gating system and to evaluate the effect of tumor/organ motion on the dosimetry, local control and survival.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo hypofractionated stereotactic body radiation therapy in 5 fractions on days 1-5. Patients receive fluorouracil intravenously (IV) over 24 hours on day 1 weekly for 4 weeks or capecitabine orally (PO) every 12 hours starting the evening before day 1 of radiation therapy for 4 weeks as per standard of care. Patients then undergo surgery 6-8 weeks after completion of radiation therapy.
ARM B: Patients receive zoledronic acid IV over no less than 15 minutes 1 week prior to radiation therapy. Patients undergo hypofractionated stereotactic body radiation therapy and receive treatment with fluorouracil IV or capecitabine PO as in Arm A. Patients then undergo surgery 6-8 weeks after completion of radiation therapy.
After completion of study treatment, patients are followed up for 30 days, every 3 months for the first year, every 4 months for the second year, and then every 6 months thereafter.
Source: View full study details on ClinicalTrials.gov
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