100 Participants Needed

Radiation Therapy with CivaSheet® for Sarcoma

Recruiting at 1 trial location
KP
CC
Overseen ByCarra Castagnero
Age: Any Age
Sex: Any
Trial Phase: Phase 4
Sponsor: CivaTech Oncology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Radiation Therapy with CivaSheet® for Sarcoma is an effective treatment?

The available research shows that brachytherapy, which includes treatments like CivaSheet®, is effective for soft tissue sarcomas. It helps control the tumor locally, meaning it can stop the tumor from growing back in the same place after surgery. Studies have shown that brachytherapy can be as effective as other radiation treatments, like external beam radiotherapy, but with some added benefits. It can deliver high doses of radiation directly to the tumor area, which can reduce the time needed for treatment and lower costs. Additionally, it is less likely to affect the surrounding healthy tissue, which is important for preserving the function of the affected area. In some cases, it can be used alone or with other treatments to improve outcomes, especially in challenging cases like recurrent tumors or when the tumor is near critical body parts.12345

What safety data exists for CivaSheet in treating sarcoma?

The CivaSheet, a palladium-103 brachytherapy device, has been evaluated in various studies. Initial clinical experiences, such as the one involving 10 cases of soft tissue sarcoma, have been documented. The device is designed to emit unidirectional radiation, allowing for targeted treatment while sparing healthy tissues. It has been used in different cancer types, including pancreatic cancer, where it helps achieve negative surgical margins. The CivaSheet is FDA-cleared and has undergone dosimetric characterization to ensure its safety and effectiveness in clinical settings.678910

Is the treatment CivaSheet a promising treatment for sarcoma?

Yes, CivaSheet is a promising treatment for sarcoma because it allows for targeted radiation, which means it can deliver high doses to the tumor while protecting healthy tissues. This makes it a valuable option for patients who have already received the maximum safe dose of radiation.6781112

Research Team

Dian Wang, MD, PhD - Rush University ...

Dian Wang, MD, PhD

Principal Investigator

Rush University Medical Center

KH

Krisha Howell, MD

Principal Investigator

Michigan Healthcare Professionals

Eligibility Criteria

This trial is for sarcoma patients who can have surgery and whose cancer appears in the retroperitoneum, abdomen, pelvis, or trunk. Participants must be able to stay under the care of the enrolling center and give informed consent. It's not open to those unwilling to follow protocol requirements, involved in other unapproved studies, or women who are pregnant or breastfeeding.

Inclusion Criteria

I am fit for surgery.
Subject plans to remain in the long-term care of his/her enrolling center/investigators
My scans show sarcoma, confirmed by biopsy or suspected but not biopsied.
See 4 more

Exclusion Criteria

Pregnancy
Is unable or unwilling to comply with protocol requirements
Is enrolled in another study/registry not approved by CivaTech Oncology
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

CivaSheet is implanted during tumor removal to deliver targeted radiation

Immediate (during surgery)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Monitoring for disease progression, recurrence rates, and reoperation rates

5 years

Treatment Details

Interventions

  • CivaSheet
Trial OverviewThe study is testing CivaSheet®, a device that's implanted during surgery and releases low dose rate radiation directly into the tumor area using Palladium-103. The goal is to see how safe it is and what side effects might occur when used in treating sarcomas located within specific body regions.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: CivaSheet TreatmentExperimental Treatment1 Intervention
Implanted with CivaSheet during tumor removal

CivaSheet is already approved in United States for the following indications:

🇺🇸
Approved in United States as CivaSheet for:
  • Lung cancer
  • Pancreatic cancer
  • Soft tissue sarcomas
  • Colorectal cancer
  • Gynecologic cancer
  • Head and neck cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

CivaTech Oncology

Lead Sponsor

Trials
7
Recruited
310+

TAB Clinical

Collaborator

Trials
2
Recruited
130+

Findings from Research

Brachytherapy is an effective and safe treatment option for high-grade soft tissue sarcomas, particularly in cases with central localization or positive resection margins, as shown in a randomized trial by MSKCC.
When used according to specific guidelines, brachytherapy can enhance local control of the tumors while maintaining an acceptable level of complications, making it a valuable part of the multidisciplinary approach to treating soft tissue sarcomas.
[Brachytherapy in soft tissue sarcomas].Thomas, L., Delannes, M.[2019]
In a study of 18 pediatric patients with soft tissue sarcoma, high dose rate brachytherapy (HBRT) alone achieved a remarkable 100% local control rate, with an overall survival rate of 84.5% after a median follow-up of 79.5 months.
Combining HBRT with external beam radiotherapy (EBRT) resulted in a slightly lower local control rate of 90%, but both treatment approaches demonstrated tolerable side effects, primarily local erythema and wound dehiscence.
High-dose-rate brachytherapy for soft tissue sarcoma in children: a single institution experience.Viani, GA., Novaes, PE., Jacinto, AA., et al.[2021]
Perioperative brachytherapy provides better local control of extremity soft tissue sarcoma compared to surgery alone, allowing for high radiation doses to be delivered directly to the tumor site while minimizing exposure to surrounding healthy tissue.
Recent advancements in high-dose-rate (HDR) brachytherapy enable outpatient treatment and tailored radiation delivery, showing promising local control rates and potentially replacing traditional low-dose-rate methods, which required longer patient isolation.
Current results of brachytherapy for soft tissue sarcoma.Ballo, MT., Lee, AK.[2019]

References

[Brachytherapy in soft tissue sarcomas]. [2019]
High-dose-rate brachytherapy for soft tissue sarcoma in children: a single institution experience. [2021]
Current results of brachytherapy for soft tissue sarcoma. [2019]
Flap reconstruction and interstitial brachytherapy in nonextremity soft tissue sarcoma. [2019]
Brachytherapy for Organ and Function Preservation in Soft-Tissue Sarcomas in Adult and Paediatric Patients. [2023]
CivaSheet® use for soft tissue sarcoma: A single institution experience. [2023]
Intraoperative implantation of a mesh of directional palladium sources (CivaSheet): Dosimetry verification, clinical commissioning, dose specification, and preliminary experience. [2018]
A directional 103Pd brachytherapy device: Dosimetric characterization and practical aspects for clinical use. [2018]
CivaSheet intraoperative radiation therapy for pancreatic cancer. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Dosimetric characterization of a new directional low-dose rate brachytherapy source. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Application of a directional palladium-103 brachytherapy device on a curved surface. [2019]
[Comparison of intensity-modulated postoperative radiotherapy with conventional postoperative conformal radiotherapy for retroperitoneal sarcoma]. [2016]