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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02843945
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : July 20, 2020
Information provided by (Responsible Party):
CivaTech Oncology

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Device: Directional Brachytherapy Source Implant Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Dose escalation Phase I followed by a feasibility trial in Phase II
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
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 :
  1. Safety of CivaSheet Radiation Treatement [ Time Frame: 1 Year ]
    Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.

Secondary Outcome Measures :
  1. Efficacy of CivaSheet Radiation Treatment [ Time Frame: 1 Year ]
    Patients will be monitored for one year to determine the local cancer recurrence rate

  2. Morbidity of patients following surgery and radiation [ Time Frame: 2 Year ]
    2 year survival rates for patients post surgery and CivaSheet radiation treatment

  3. Post Operative Radiation Dosimetry Calculation [ Time Frame: 1 Month ]
    Post procedure 3D treatment planning will be performed to determine if the radiation dose delivered was satisfactory

  4. Length of Hospital Stay [ Time Frame: 1 Month ]
    Length of hospital stay will be monitored to determine if CivaSheet radiation treatment alters the typical length of hospital stay for patients after surgery.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy 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
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02843945

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Contact: Carra Castagnero 919-314-5515
Contact: Kristy Perez, PhD 9193145515

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United States, Illinois
Rush University Cancer Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Zachary Miller    312-563-2008   
Principal Investigator: Dian Wang, MD         
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Colleen Valenti, OCN    708-684-4694   
Principal Investigator: Paul Crossan, MD         
Sub-Investigator: Marc Mesleh, MD         
United States, Louisiana
University Medical Center LSU Recruiting
New Orleans, Louisiana, United States, 70112
Principal Investigator: Jennifer Gnerlich, MD         
Sub-Investigator: Ellen Zakris, MD         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Andrew Novak    215-728-3512   
Principal Investigator: Josh Meyer, MD         
Sub-Investigator: Sanjay Reddy, MD         
United States, Virginia
Virginia Commonwealth University Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Daeryl Williamson    804-628-2334   
Principal Investigator: Emma Fields, MD         
Sub-Investigator: Brian Kaplan, MD         
Sponsors and Collaborators
CivaTech Oncology
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Principal Investigator: Joshua Meyer, MD Fox Chase Cancer Center
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Responsible Party: CivaTech Oncology Identifier: NCT02843945    
Other Study ID Numbers: CT004
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by CivaTech Oncology:
borderline resectable
locally advanced
intraoperative radiation
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases