Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Sarcoma

Intervention / Treatment
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* Device: CivaSheet


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CivaSheet Treatment<br>Implanted with CivaSheet during tumor removal | Device: CivaSheet<br>* Implanting CivaSheet radiation therapy device at the time of surgery to irradiate surgical margin potentially preventing local recurrence<br>* Other names: Intraoperative Radiation Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of acute toxicity | rate of greater than or equal to Grade 3 toxicity events based on CTCAE criteria | 90 days post implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control rate | rate of local tumor recurrences | 5 years | 
| Reoperation rate | Rate of re-operation for any reason | 5 years | 
| Complication rate | Rate of complications following device implant related or unrelated to the device | 6 months | 
| Dose to target and OAR | Amount of radiation dose delivered to the target volume and the adjacent organs at risk | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CivaSheet, IORT, Intraoperative Radiation Therapy, Brachytherapy