Clinical Trial TitleSafety and efficacy of permanently implantable LDR CivaSheet® in combination with external beam radiation in the treatment of pancreatic cancer.
Clinical Trial Protocol Description:
This is a feasibility study to determine the safety and efficacy of a new brachytherapy device that provides unidirectional radiation which utilizes active components (Palladium-103) of standard devices in a novel configuration. This pilot study may benefit pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin. The appropriate dose and local control rate will be recorded the primary endpoint in order to provide an efficacy assessment.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are capable of undergoing anesthesia.
- Have been selected to undergo Whipple procedure.
- Do not have metastatic disease.
- Have suspected R0 or R1 margins.
- Have no prior radiation therapy to the region for separate cancer.
- Have a confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma.
This is a partial list of elgibility requirements.