Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

Registry of Retroperitoneal, Abdominal, Pelvic and Truncal Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet® to Evaluate the Safety and Feasibility Over 5 Years

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcoma
• Intervention / Treatment: Device: CivaSheet

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kristy Perez, PhD; Phone Number: 9193145515; Email: clinical@civatechoncology.com
• Study Contact Backup: Name: Carra Castagnero; Phone Number: 9193145515; Email: clinical@civatechoncology.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Not yet recruiting
      • RUSH University Cancer Center
      • Contact: Riley Sticca; Phone Number: 312-563-5769; Email: riley_j_sticca@Rush.edu
      • Principal Investigator: Dian Wang, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Recruiting
      • Fox Chase Cancer Center
      • Contact: Sara McCarney, BSN; Phone Number: 215-728-3512; Email: sara.mccarney@fccc.edu
      • Principal Investigator: Krisha Howell, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CivaTech Oncology
• Collaborators: TAB Clinical
• Investigators: Principal Investigator: Krisha Howell, MD, Fox Chase Cancer Center; Principal Investigator: Dian Wang, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Brachytherapy; IORT; CivaSheet; Intraoperative Radiation Therapy
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: CT007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No