Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®
Status:
Recruiting
Sponsors
CivaTech Oncology
Collaborators
TAB Clinical
Abstract:
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.
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.
Last Verified:June/30/2020
First Submitted:July/22/2019
Estimated Enrollment Submitted:July/22/2019
First Posted:July/24/2019
Last Update Submitted:July/16/2020
Last Update Posted:July/20/2020
Actual Study Start Date:April/29/2020
Estimated Primary Completion Date:November/30/2021
Estimated Study Completion Date:July/31/2025
Condition or disease:Sarcoma
Intervention/treatment:
Device: CivaSheet Treatment
Phase:Phase 4
Study design:
Study Type:Interventional
Allocation:N/A
Primary Purpose:Treatment
Masking:None (Open Label)
Arm group:
ArmIntervention/treatment
Experimental: CivaSheet Treatment
Implanted with CivaSheet during tumor removal
Device: CivaSheet Treatment
Implanting CivaSheet radiation therapy device at the time of surgery to irradiate surgical margin potentially preventing local recurrence
Eligibility Criteria:
Sexes Eligible for Study:All
Accepts Healthy Volunteers:Yes
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

Outcome:
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
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