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OpenTrials
Active, Not Recruiting

NCT Number: NCT04033081

Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject Signed Inform Consent
  • Subject plans to remain in the long-term care of his/her enrolling center/investigators.
  • Sarcoma evident on imaging. Pathology biopsy proven or suspected by imaging but not a biopsy candidate.
  • Sarcoma in the retroperitoneum, abdomen, pelvis, or trunk
  • Subject is able to undergo surgery

Exclusion criteria

  • Is unable or unwilling to comply with protocol requirements.
  • Is enrolled in another study/registry not approved by CivaTech Oncology.
  • Pregnancy, breast feeding

Treatment and study plan

CivaSheet

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CivaTech Oncology

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2027
Study completion
2030
First posted
Jul 25, 2019
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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