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

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.

Interventions

• Directional Brachytherapy Source Implant · DEVICE

  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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (6)

• 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, Richmond, Virginia · COMPLETED