Clinical trial NCT04033081: Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Sarcoma
Keywords: CivaSheet
IORT
Intraoperative Radiation Therapy
Brachytherapy
Lead sponsor: CivaTech Oncology
Sponsor class: INDUSTRY
First posted: 2019-07-25
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of acute toxicity
timeFrame: 90 days post implant
Secondary outcomes:
measure: Local control rate
timeFrame: 5 years
measure: Reoperation rate
timeFrame: 5 years
measure: Complication rate
timeFrame: 6 months
measure: Dose to target and OAR
timeFrame: 90 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Rush University Medical Center
name: Dian Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan Healthcare Professionals
name: Krisha Howell, MD
role: PRINCIPAL_INVESTIGATOR
References: