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Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

Sponsor
CivaTech Oncology (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04033081
Collaborator
TAB Clinical (Other)
100
Enrollment
2
Locations
1
Arm
103.1
Anticipated Duration (Months)
50
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This patient study will determine the safety and toxicity of a permanently implantable brachytherapy source - CivaSheet® - which is designed to deliver a therapeutic dose of low dose rate (LDR) radiation with polymer encased Palladium-103. CivaSheet will be implanted in sarcoma patients with disease presenting in the retroperitoneum, abdomen, pelvis and trunk.

Condition or Disease Intervention/Treatment Phase
  • Device: CivaSheet
 Phase 4

Detailed Description

CivaSheet® is an FDA-cleared product from CivaTech Oncology®. It is a series of small radioactive palladium-103 (Pd-103) sources on bio-absorbable, flexible, bio-compatible membrane. The CivaSheet can be custom cut in the operating room. The CivaSheet is 5 cm wide by 15 cm long and has a rim to allow an easy surface to suture. This flexible device can contour the surgical cavity delivering highly conformal and targeted radiation dose. CivaSheet can deliver a very high radiation dose to the surgical margin to potential prevent local cancer recurrence.

Sarcoma patients have up to 80% local recurrence rates, depending on histology and location of disease presentation. CivaSheet will be implanted at the surgical margin follow tumor removal. Monitoring the rate of acute toxicity is the primary endpoint. Secondary endpoints include disease progression and recurrence rates.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Registry of Retroperitoneal, Abdominal, Pelvic and Truncal Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet® to Evaluate the Safety and Feasibility Over 5 Years
Actual Study Start Date :
Apr 30, 2020
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: CivaSheet Treatment

Implanted with CivaSheet during tumor removal

Device: CivaSheet
Implanting CivaSheet radiation therapy device at the time of surgery to irradiate surgical margin potentially preventing local recurrence
Other Names:
  • brachytherapy
  • Intraoperative Radiation Therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of acute toxicity [90 days post implant]

      rate of greater than or equal to Grade 3 toxicity events based on CTCAE criteria

    Secondary Outcome Measures

    1. Local control rate [5 years]

      rate of local tumor recurrences

    2. Reoperation rate [5 years]

      Rate of re-operation for any reason

    3. Complication rate [6 months]

      Rate of complications following device implant related or unrelated to the device

    4. Dose to target and OAR [90 days]

      Amount of radiation dose delivered to the target volume and the adjacent organs at risk

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Subject Signed Inform Consent

    2. Subject plans to remain in the long-term care of his/her enrolling center/investigators.

    3. Sarcoma evident on imaging. Pathology biopsy proven or suspected by imaging but not a biopsy candidate.

    4. Sarcoma in the retroperitoneum, abdomen, pelvis, or trunk

    5. Subject is able to undergo surgery

    Exclusion Criteria:

    1. Is unable or unwilling to comply with protocol requirements.

    2. Is enrolled in another study/registry not approved by CivaTech Oncology.

    3. Pregnancy, breast feeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rush University Cancer Center Chicago Illinois United States 60612
    2 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111

    Sponsors and Collaborators

    • CivaTech Oncology
    • TAB Clinical

    Investigators

    • Principal Investigator: Krisha Howell, MD, Fox Chase Cancer Center
    • Principal Investigator: Dian Wang, MD, Rush University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CivaTech Oncology
    ClinicalTrials.gov Identifier:
    NCT04033081
    Other Study ID Numbers:
    • CT007
    First Posted:
    Jul 25, 2019
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    CivaSheet
    IORT
    Intraoperative Radiation Therapy
    Brachytherapy
    Additional relevant MeSH terms:
    Sarcoma

    Study Results

    No Results Posted as of Mar 2, 2022