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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2020
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2019
CompletedFirst Posted
Study publicly available on registry
July 25, 2019
CompletedStudy Start
First participant enrolled
April 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2030
March 23, 2026
March 1, 2026
6.7 years
July 23, 2019
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of acute toxicity
rate of greater than or equal to Grade 3 toxicity events based on CTCAE criteria
90 days post implant
Secondary Outcomes (4)
Local control rate
5 years
Reoperation rate
5 years
Complication rate
6 months
Dose to target and OAR
90 days
Study Arms (1)
CivaSheet Treatment
EXPERIMENTALImplanted with CivaSheet during tumor removal
Interventions
Implanting CivaSheet radiation therapy device at the time of surgery to irradiate surgical margin potentially preventing local recurrence
Eligibility Criteria
You may qualify if:
- Subject Signed Inform Consent
- Subject plans to remain in the long-term care of his/her enrolling center/investigators.
- Sarcoma evident on imaging. Pathology biopsy proven or suspected by imaging but not a biopsy candidate.
- Sarcoma in the retroperitoneum, abdomen, pelvis, or trunk
- Subject is able to undergo surgery
You may not qualify if:
- Is unable or unwilling to comply with protocol requirements.
- Is enrolled in another study/registry not approved by CivaTech Oncology.
- Pregnancy, breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dian Wang, MD
Rush University Medical Center
- PRINCIPAL INVESTIGATOR
Krisha Howell, MD
Michigan Healthcare Professionals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2019
First Posted
July 25, 2019
Study Start
April 30, 2020
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
April 1, 2030
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share