Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

Phase 4

Active, not recruiting

• Conditions: Sarcoma
• Interventions: Device: CivaSheet

• Registration Number: NCT04033081
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-25
• Study Start: 2020-04-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2027-01
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CivaSheet Treatment	CivaSheet	Implanted with CivaSheet during tumor removal

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States