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Clinical Trials in the USA / NCT02843945
Recruiting Phase 1/2

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

NCT02843945 · tracked via the Priya Life Science USA tracker
Sponsor
CivaTech Oncology
Phase
Phase 1/2
Started
2017-05-31
Last updated
2025-06-17

Condition(s) studied

Pancreatic Cancer

Investigational drug(s) / intervention(s)

Directional Brachytherapy Source Implant

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)

Trial sites (6)

FacilityCityRegionStatus
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

More CivaTech Oncology trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT02843945 on ClinicalTrials.gov ↗ ← All trials in the USA