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

RECRUITING
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18 years and over
This study is NOT accepting healthy volunteers
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

DEVICE: Directional Brachytherapy Source Implant

Pancreatic Cancer

brachytherapy, CivaSheet, CivaTech, whipple, radiation, borderline resectable, locally advanced, Pd-103, intraoperative radiation

Carra Castagnero - ccastagnero@civatechoncology.com
Fields, Emma, C
PHASE1
HM20010844
NCT02843945
See this study on ClinicalTrials.gov

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