Pancreas Cancer Clinical Trial
Official title:
Phase I Study of Low Kilovoltage Intraoperative Radiation for Patients With Resectable Pancreatic Adenocarcinoma
Currently, for patients with pancreatic cancer the standard treatment is surgery followed by
chemotherapy and/or radiation therapy. An investigational approach is to perform the surgery
and treat the area of the tumor with intraoperative radiotherapy in one procedure.
Intraoperative radiation delivers low energy x-rays to a targeted area during the time of
tumor removal.
The purpose of this study is to learn about both the good and bad effects of adding
intraoperative radiation therapy. Another goal is to determine and compare the quality of
life before and after the procedure. We will also monitor the effect of the therapy on the
cancer lesion and any complications that may result.
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.
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