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

Last updated: June 16, 2025
Sponsor: CivaTech Oncology
Overall Status: Active - Recruiting

Phase

1/2

Condition

Pancreatic Cancer

Digestive System Neoplasms

Pancreatic Disorders

Treatment

Directional Brachytherapy Source Implant

Clinical Study ID

NCT02843945
CT004
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 pancreaticadenocarcinoma

  • Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)

  • Chemotherapy was administered for 2-6 cycles with any combination of thefollowing agents:

  • Gemcitabine + nb-paclitaxel

  • FOLFIRINOX

  • Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), orSBRT (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

Exclusion Criteria:

  • Not surgical candidate

  • Any other invasive cancer in the past 5 years, except basal cell or squamous cellskin 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

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Directional Brachytherapy Source Implant
Phase: 1/2
Study Start date:
May 31, 2017
Estimated Completion Date:
October 30, 2028

Study 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.

Connect with a study center

  • Tampa General Hospital

    Tampa, Florida 33612
    United States

    Site Not Available

  • Rush University Cancer Center

    Chicago, Illinois 60612
    United States

    Completed

  • Advocate Christ Medical Center

    Oak Lawn, Illinois 60453
    United States

    Active - Recruiting

  • University Medical Center LSU

    New Orleans, Louisiana 70112
    United States

    Completed

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Completed

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Completed

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