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Registry of Retroperitoneal, Abdominal, Pelvic and Truncal Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet® to Evaluate the Safety and Feasibility Over 5 Years

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.
 
ClinicalTrials.gov Identifier: NCT04033081
Recruitment Status : Not yet recruiting
First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
TAB Clinical
Information provided by (Responsible Party):
CivaTech Oncology

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
Sarcoma 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Rate of acute toxicity [ Time Frame: 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 [ Time Frame: 5 years ]
    rate of local tumor recurrences

  2. Reoperation rate [ Time Frame: 5 years ]
    Rate of re-operation for any reason

  3. Complication rate [ Time Frame: 6 months ]
    Rate of complications following device implant related or unrelated to the device

  4. Dose to target and OAR [ Time Frame: 90 days ]
    Amount of radiation dose delivered to the target volume and the adjacent organs at risk



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT04033081


Contacts
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Contact: Carra Castagnero 9193145515 clinical@civatechoncology.com
Contact: Kristy Perez, PhD 9193145515 clinical@civatechoncology.com

Locations
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United States, Illinois
Rush University Cancer Center
Chicago, Illinois, United States, 60612
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
CivaTech Oncology
TAB Clinical
Investigators
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Principal Investigator: Krisha Howell, MD Fox Chase Cancer Center
Principal Investigator: Dian Wang, MD Rush University Medical Center

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Responsible Party: CivaTech Oncology
ClinicalTrials.gov Identifier: NCT04033081    
Other Study ID Numbers: CT007
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
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:
CivaSheet
IORT
Intraoperative Radiation Therapy
Brachytherapy
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms