RecruitingRecruiting
Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source
NCT02843945 · CivaTech Oncology
In plain English
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Official title
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
About this study
This is a Feasibility study to determine the safety and efficacy of a new brachytherapy device that provides unidirectional radiation which utilizes active components (Palladium-103) of standard devices in a novel configuration.This pilot study may benefit pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin. The appropriate dose and local control rate will be recorded the primary endpoint in order to provide an efficacy assessment.
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
Study design
Enrollment target: 80 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2017-05-31
Estimated completion: 2028-10-30
Last updated: 2025-06-17
Interventions
Device: Directional Brachytherapy Source Implant
Primary outcomes
- • Safety of CivaSheet Radiation Treatement (1 Year)
Sponsor
CivaTech Oncology · industry
Contacts & investigators
ContactCarra Castagnero · contact · ccastagnero@civatechoncology.com · 919-314-5515
ContactKristy Perez, PhD · contact · kperez@civatechoncology.com · 9193145515
InvestigatorJoshua Meyer, MD · principal_investigator, Fox Chase Cancer Center
All locations (6)
Tampa General HospitalNot Yet Recruiting
Tampa, Florida, United States
Rush University Cancer CenterCompleted
Chicago, Illinois, United States
Advocate Christ Medical CenterRecruiting
Oak Lawn, Illinois, United States
University Medical Center LSUCompleted
New Orleans, Louisiana, United States
Fox Chase Cancer CenterCompleted
Philadelphia, Pennsylvania, United States
Virginia Commonwealth University Massey Cancer CenterCompleted
Richmond, Virginia, United States