Intraoperative Radiation Therapy for Resectable Pancreas Cancer

The purpose of this study is to determine safety of low kilovoltage radiotherapy delivery of a focused dose of radiation to the areas at high risk for locoregional recurrence following pancreaticoduodenectomy. This surgery is currently the only potentially curative approach for patients with pancreatic cancer. Unfortunately, following surgery alone \>50% of patients will have a local recurrence of disease \[5\]. Local control will become increasingly important as chemotherapy regimens continue to improve the distant metastases-free survival. Intraoperative radiation therapy allows direct access to the tumor bed and areas of concern while allowing displacement and shielding of normal tissue and organs at risk of radiation toxicity. Study Objectives The primary objective is to determine the maximum tolerated dose (MTD) for low kilovoltage (kV) intraoperative radiotherapy (IORT) The secondary objectives are: To develop acute and chronic toxicity profiles for this treatment modality To determine the feasibility of including low-kV IORT in the treatment of pancreatic cancer To evaluate the following physics and delivery parameters: treatment prescription dose, depth of treatment, applicator type, and treatment time. To measure patient's quality of life (QOL) before and after treatment, including change in pain level and fatigue level. To describe the disease specific outcomes of local regional control, progression free-survival, distant metastasis free-survival, disease free-survival and overall survival associated with low-kV IORT following pancreaticoduodenectomy.