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Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source
RecruitingPhase 1/2
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Directional Brachytherapy Source Implant (device)
Sponsor: CivaTech Oncology · Participants: 80 · Started: May 31, 2017
Contact the study team
- Carra Castagnero · Phone: 919-314-5515
- Kristy Perez, PhD · Phone: 9193145515
Official record on ClinicalTrials.gov — NCT02843945
Locations in the U.S.
| Florida | Tampa General Hospital, Tampa (Not yet recruiting) |
| Illinois | Advocate Christ Medical Center, Oak Lawn |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.