NCT02843945
Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source
Recruiting
PHASE1Ages 18+InterventionalTreatmentCivaTech Oncology
~80 participants
Updated 2025-06-17 on ClinicalTrials.gov
What's tested:Directional Brachytherapy Source Implant
At a glance
Recruiting sites
1 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of CivaSheet Radiation Treatement
Measured over 1 Year
Conditions
Where it's being run
6 sites across 5 statesIllinois2
Florida1
Louisiana1
Pennsylvania1
Virginia1
Study leadership
- Joshua Meyer, MD · PRINCIPAL_INVESTIGATOR · Fox Chase Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
• 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
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
What this trial measures
- Safety of CivaSheet Radiation Treatement1 Year
Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.