Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source
NCT ID: NCT02843945
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
80 participants
INTERVENTIONAL
2017-05-31
2028-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Directional Brachytherapy Source Implant
Patients undergoing a pancreatic cancer resection will receive a CivaSheet LDR directional brachytherapy implant at the time of surgery. The directional nature of the FDA cleared CivaSheet is expected to allow physicians to increase the radiation dose given to the surgical margin safely, reducing risk of recurrence without increasing radiation side effects.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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CivaTech Oncology
INDUSTRY
Responsible Party
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Principal Investigators
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Joshua Meyer, MD
Role: PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center
Locations
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Tampa General Hospital
Tampa, Florida, United States
Rush University Cancer Center
Chicago, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
University Medical Center LSU
New Orleans, Louisiana, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CT004
Identifier Type: -
Identifier Source: org_study_id
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