Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2030-04-30

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.

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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.

Conditions

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Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CivaSheet Treatment

Implanted with CivaSheet during tumor removal

Group Type EXPERIMENTAL

CivaSheet

Intervention Type DEVICE

Implanting CivaSheet radiation therapy device at the time of surgery to irradiate surgical margin potentially preventing local recurrence

Interventions

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CivaSheet

Implanting CivaSheet radiation therapy device at the time of surgery to irradiate surgical margin potentially preventing local recurrence

Intervention Type DEVICE

Other Intervention Names

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brachytherapy Intraoperative Radiation Therapy

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No