Spots Global Cancer Trial Database for Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source

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Trial Identification

Brief Title: Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source

Official Title: Initial Feasibility Study to Evaluate the Safety and Efficacy of the Permanently Implantable LDR CivaSheet® in Combination With External Beam Radiation in the Treatment of Pancreatic Cancer

Study ID: NCT02843945

Conditions

Pancreatic Cancer

Interventions

Directional Brachytherapy Source Implant

Study Description

Brief Summary: Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.

Detailed 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.