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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT02843945Sponsor: CivaTech OncologyLast updated: 2025-06-17

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.

Detailed description

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.

Arms & interventions

  • DeviceDirectional 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.

Outcome measures

Primary

  • Safety of CivaSheet Radiation Treatement

    Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.

    Time frame: 1 Year

Secondary

  • Efficacy of CivaSheet Radiation Treatment

    Time frame: 1 Year

  • Morbidity of patients following surgery and radiation

    Time frame: 2 Year

  • Post Operative Radiation Dosimetry Calculation

    Time frame: 1 Month

  • Length of Hospital Stay

    Time frame: 1 Month

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (6)

Tampa General Hospital

Tampa, Florida, 33612

Not Yet Recruiting
Raegen Einsmann · Contact
Timothy Nywening, MD · Principal Investigator

Rush University Cancer Center

Chicago, Illinois, 60612

Completed

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453

Recruiting
Colleen Valenti, OCN · Contact
Paul Crossan, MD · Principal Investigator
Marc Mesleh, MD · Sub Investigator

University Medical Center LSU

New Orleans, Louisiana, 70112

Completed

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Completed

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298

Completed