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Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

Primary Purpose

Sarcoma

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

CivaSheet

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring CivaSheet, IORT, Intraoperative Radiation Therapy, Brachytherapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Is unable or unwilling to comply with protocol requirements.
Is enrolled in another study/registry not approved by CivaTech Oncology.
Pregnancy, breast feeding

Sites / Locations

Rush University Cancer Center
Fox Chase Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CivaSheet Treatment

Arm Description

Implanted with CivaSheet during tumor removal

Outcomes

Primary Outcome Measures

Rate of acute toxicity

rate of greater than or equal to Grade 3 toxicity events based on CTCAE criteria

Secondary Outcome Measures

Local control rate

rate of local tumor recurrences

Reoperation rate

Rate of re-operation for any reason

Complication rate

Rate of complications following device implant related or unrelated to the device

Dose to target and OAR

Amount of radiation dose delivered to the target volume and the adjacent organs at risk

Full Information

NCT ID

NCT04033081

First Posted

July 23, 2019

Last Updated

September 7, 2023

Sponsor

CivaTech Oncology

1. Study Identification

Unique Protocol Identification Number

NCT04033081

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 30, 2020 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CivaTech Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma

Keywords

CivaSheet, IORT, Intraoperative Radiation Therapy, Brachytherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CivaSheet Treatment

Arm Type

Experimental

Arm Description

Implanted with CivaSheet during tumor removal

Intervention Type

Device

Intervention Name(s)

CivaSheet

Other Intervention Name(s)

brachytherapy, Intraoperative Radiation Therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of acute toxicity

Description

rate of greater than or equal to Grade 3 toxicity events based on CTCAE criteria

Time Frame

90 days post implant

Secondary Outcome Measure Information:

Title

Local control rate

Description

rate of local tumor recurrences

Time Frame

5 years

Title

Reoperation rate

Description

Rate of re-operation for any reason

Time Frame

5 years

Title

Complication rate

Description

Rate of complications following device implant related or unrelated to the device

Time Frame

6 months

Title

Dose to target and OAR

Description

Amount of radiation dose delivered to the target volume and the adjacent organs at risk

Time Frame

90 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: Is unable or unwilling to comply with protocol requirements. Is enrolled in another study/registry not approved by CivaTech Oncology. Pregnancy, breast feeding

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carra Castagnero

Phone

9193145515

clinical@civatechoncology.com

First Name & Middle Initial & Last Name or Official Title & Degree

Kristy Perez, PhD

Phone

9193145515

clinical@civatechoncology.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Krisha Howell, MD

Organizational Affiliation

Fox Chase Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dian Wang, MD

Organizational Affiliation

Rush University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rush University Cancer Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Riley Sticca

Phone

312-563-5769

riley_j_sticca@Rush.edu

First Name & Middle Initial & Last Name & Degree

Dian Wang, MD

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sara McCarney, BSN

Phone

215-728-3512

sara.mccarney@fccc.edu

First Name & Middle Initial & Last Name & Degree

Krisha Howell, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

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