Directional 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* • Subject signed inform consent
* Age \> 18 years
* Not pregnant or breast feeding
* Patient capable of undergoing anesthesia
* Patient selected to undergo Whipple procedure or distal pancreatectomy
* Patient does not have metastatic disease
* Patients will have close margins
* No prior radiation therapy to the region for separate cancer
* Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma
* Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)
* Chemotherapy was administered for 2-6 cycles with any combination of the following agents:
* Gemcitabine + nb-paclitaxel
* FOLFIRINOX
* Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN)
* up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil
Exclusion Criteria:
* Not surgical candidate
* Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer
* An IRE candidate (IRE is Percutaneous irreversible electroporation)
* Recurrent or previously resected tumors
* Documented History of Alcoholism and or drug abuse
* Participant in other clinical trials
Primary outcome measure(s)
Safety of CivaSheet Radiation Treatement — 1 Year Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.
Trial sites (6)
Facility
City
Region
Status
Tampa General Hospital
Tampa
Florida
Not Yet Recruiting
Rush University Cancer Center
Chicago
Illinois
Completed
Advocate Christ Medical Center
Oak Lawn
Illinois
Recruiting
University Medical Center LSU
New Orleans
Louisiana
Completed
Fox Chase Cancer Center
Philadelphia
Pennsylvania
Completed
Virginia Commonwealth University Massey Cancer Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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