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
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.
Arms & interventions
- DeviceDirectional Brachytherapy Source Implant
The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiaiton source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.
Outcome measures
Primary
Safety of CivaSheet Radiation Treatement
Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.
Time frame: 1 Year
Secondary
Efficacy of CivaSheet Radiation Treatment
Time frame: 1 Year
Morbidity of patients following surgery and radiation
Time frame: 2 Year
Post Operative Radiation Dosimetry Calculation
Time frame: 1 Month
Length of Hospital Stay
Time frame: 1 Month
Eligibility criteria
Study locations (6)
Tampa General Hospital
Tampa, Florida, 33612
Rush University Cancer Center
Chicago, Illinois, 60612
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
University Medical Center LSU
New Orleans, Louisiana, 70112
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298