NCT02843945 · CivaTech Oncology
Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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.
Primary outcome measures
Safety of CivaSheet Radiation Treatement
Time frame: 1 Year
Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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 candidat
Where
- Tampa, Florida
- Chicago, Illinois
- Oak Lawn, Illinois
- New Orleans, Louisiana
- Philadelphia, Pennsylvania
- Richmond, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2025 · Source of record for eligibility and locations