Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

Sarcoma Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04033081
• Other study ID #: CT007
• Status: Recruiting
• Phase: Phase 4
• Start date: April 30, 2020
• Est. completion date: December 2028

Study information

• Verified date: September 2023
• Source: CivaTech Oncology
• Contact: Carra Castagnero
• Phone: 9193145515
• Email: clinical[@]civatechoncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2028
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma

Intervention

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

Locations

Country	Name	City	State
United States	Rush University Cancer Center	Chicago	Illinois
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
CivaTech Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of acute toxicity	rate of greater than or equal to Grade 3 toxicity events based on CTCAE criteria	90 days post implant
Secondary	Local control rate	rate of local tumor recurrences	5 years
Secondary	Reoperation rate	Rate of re-operation for any reason	5 years
Secondary	Complication rate	Rate of complications following device implant related or unrelated to the device	6 months
Secondary	Dose to target and OAR	Amount of radiation dose delivered to the target volume and the adjacent organs at risk	90 days