Radiation Therapy with CivaSheet® for Sarcoma

Not currently recruiting at 1 trial location

Overseen By Carra Castagnero

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: CivaTech Oncology

Disqualifiers: Pregnancy, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate (during surgery)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CivaSheet, which delivers radiation directly to tumors. The goal is to assess its safety and effectiveness for people with sarcomas in the belly, pelvis, or trunk. Those with sarcoma visible on scans who can undergo surgery might be suitable candidates for this study. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

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 is the safety track record for CivaSheet?

Research has shown that the CivaSheet is generally well-tolerated as a treatment. In studies, this new radiation device did not cause significant radiation-related complications. It delivers focused radiation, targeting cancer cells while protecting nearby healthy tissues.

Reports from previous patients treated for pelvic sarcoma with the CivaSheet showed successful results without major side effects. However, using this device near sensitive organs requires extra care to prevent damage. Overall, other studies have used the CivaSheet effectively, suggesting it is safe for many patients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

CivaSheet is unique because it offers a new approach to treating sarcomas through direct, localized radiation therapy. Unlike traditional external beam radiation, which affects a broader area and can harm surrounding healthy tissues, CivaSheet is surgically implanted at the tumor site during removal. This means it delivers radiation precisely where it's needed, potentially reducing side effects and improving recovery times. Researchers are excited about CivaSheet because it targets cancer cells more directly and could lead to better outcomes for patients with sarcomas.

What evidence suggests that the CivaSheet device is effective for sarcoma?

In this trial, participants will receive treatment with the CivaSheet, which has shown promise in previous studies for treating sarcoma. Research has demonstrated that the CivaSheet delivers a controlled amount of radiation directly to the tumor. This targeted method helps protect the healthy tissue around the tumor while effectively treating the cancer. In past studies, patients received radiation doses between 20 to 60 Gy, which effectively shrank tumors. Additionally, the CivaSheet uses a special palladium-103 source that directs radiation in one direction, further reducing harm to nearby tissues. Overall, the CivaSheet aims to improve outcomes for sarcoma patients by focusing radiation precisely where needed. ^{1 2 4 6 7}

Who Is on the Research Team?

Dian Wang, MD, PhD

Principal Investigator

Rush University Medical Center

Krisha Howell, MD

Principal Investigator

Michigan Healthcare Professionals

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Pregnancy

Is unable or unwilling to comply with protocol requirements

Is enrolled in another study/registry not approved by CivaTech Oncology

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• CivaSheet

Trial Overview The 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.

How Is the Trial Designed?

Group I: CivaSheet Treatment Experimental Treatment 1 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

Who Is Running the Clinical Trial?

CivaTech Oncology

Lead Sponsor

Trials

7

Recruited

310+

TAB Clinical

Collaborator

Trials

2

Recruited

130+

Published Research Related to This Trial

The CivaSheet is an FDA-cleared implantable device that uses low-dose-rate Palladium-103 to target areas at risk of cancer recurrence after surgery for borderline resectable pancreatic cancer, potentially improving outcomes by addressing close or positive surgical margins.

This innovative approach allows for customized implantation during surgery, aiming to reduce local recurrences and improve overall survival, although the study also highlights the ongoing challenges in achieving negative margins in pancreatic cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CivaSheet intraoperative radiation therapy for pancreatic cancer. Taylor, RJ., Todor, D., Kaplan, BJ., et al.[2022]

CivaSheet, an implantable radiation therapy device, was used in 10 cases of soft tissue sarcoma, delivering an average radiation dose of 47 Gy, and showed potential as an alternative to traditional brachytherapy methods.

Despite a local recurrence rate of 40% and some significant complications (Grade 4), the initial clinical experience suggests that CivaSheet could be a viable option for patients who have reached their maximum radiation dose, especially in complex cases requiring reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CivaSheet® use for soft tissue sarcoma: A single institution experience. Seldon, C., Grossman, JG., Shrivastava, G., et al.[2023]

The CivaSheet brachytherapy device, designed to preferentially irradiate tumors while protecting healthy tissues, demonstrated a lower dose-rate constant compared to traditional 103Pd seeds, indicating a more controlled radiation delivery.

Dosimetric evaluations showed that the CivaSheet's shielding significantly reduces radiation exposure in certain directions, with a dramatic anisotropy factor, suggesting its potential for targeted cancer treatment while minimizing damage to surrounding healthy tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A directional 103Pd brachytherapy device: Dosimetric characterization and practical aspects for clinical use. Rivard, MJ.[2018]

The clinical commissioning of the CivaSheet, a novel 103Pd directional brachytherapy device, successfully established source calibration and validated treatment planning systems, ensuring accurate dose delivery for intraoperative radiation therapy.

Experimental verification showed that the dosimetry parameters were accurate within standard clinical uncertainties, with dose differences remaining within acceptable limits, confirming the device's efficacy for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative implantation of a mesh of directional palladium sources (CivaSheet): Dosimetry verification, clinical commissioning, dose specification, and preliminary experience. Cohen, GN., Episcopia, K., Lim, SB., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy for soft tissue sarcoma in children: a single institution experience. Viani, GA., Novaes, PE., Jacinto, AA., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Brachytherapy in soft tissue sarcomas]. Thomas, L., Delannes, M.[2019]

Intensity-modulated radiation therapy (IMRT) can potentially increase the prescribed dose for treating retroperitoneal sarcoma from 45 Gy to 54 Gy while better protecting adjacent organs at risk, such as the kidneys and spinal cord.

The study demonstrated that IMRT improves dose homogeneity and coverage for the target volume, with a 5% enhancement in dose uniformity and a 13% increase in coverage factor, while also improving the protection of surrounding organs by 20%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of intensity-modulated postoperative radiotherapy with conventional postoperative conformal radiotherapy for retroperitoneal sarcoma]. Musat, E., Kantor, G., Caron, J., et al.[2016]

The CivaDot brachytherapy source demonstrated excellent repeatability and reproducibility in primary source strength measurements, with less than 1.1% agreement across different measurement methods, indicating reliable performance for clinical use.

Dose distribution measurements showed that the CivaDot's predicted and measured dose rates were closely aligned, with differences generally within 2-3%, suggesting that the CivaDot can deliver precise radiation therapy effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric characterization of a new directional low-dose rate brachytherapy source. Aima, M., DeWerd, LA., Mitch, MG., et al.[2020]

The study analyzed the dosimetric impact of the CivaSheet device, which uses directional palladium-103 sources, when implanted on curved surfaces, revealing that curvature significantly affects dose distribution.

Results showed that on inward-facing curved implants, the dose could exceed the prescribed amount by about 20%, while outward-facing implants could lead to a 20% decrease in dose, highlighting the need for careful planning to avoid overdosing healthy tissue or underdosing the tumor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of a directional palladium-103 brachytherapy device on a curved surface. Veltchev, I., Price, R., Chen, X., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current results of brachytherapy for soft tissue sarcoma. Ballo, MT., Lee, AK.[2019]

Interstitial brachytherapy can be effectively used in the treatment of recurrent high-grade non-extremity sarcomas following surgical excision and soft tissue reconstruction, offering a targeted radiotherapy option.

This approach may provide advantages over traditional external beam radiotherapy, although concerns about its use with flap reconstruction have been noted, indicating a need for careful consideration in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flap reconstruction and interstitial brachytherapy in nonextremity soft tissue sarcoma. Goel, V., Goel, A., Gupta, N., et al.[2019]

Brachytherapy is an effective method for delivering adjuvant radiotherapy in soft-tissue sarcomas, achieving a 5-year local control rate of 80-85%, while minimizing damage to surrounding healthy tissue.

High dose rate brachytherapy is preferred due to its convenience, safety, and flexibility in dose optimization, making it suitable for various patient populations, including those with recurrent tumors and special age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brachytherapy for Organ and Function Preservation in Soft-Tissue Sarcomas in Adult and Paediatric Patients. Laskar, S., Manjali, JJ., Chargari, C., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12167782/

Prospective Evaluation of a Novel Unidirectional ... The CivaSheet is a novel radiation delivery device consisting of unidirectionally shielded Pd-103 sources embedded in a bioabsorbable polymer sheet.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480421004728

Initial Clinical Experience With Novel Directional Low-Dose ... An LDR brachytherapy dose of 20-60 Gy was administered, corresponding to biologically effective dose values of 15-53 Gy and equivalent dose values of 12-43 Gy.

3. advancesradonc.com advancesradonc.com/article/S2452-1094(17)30228-2/fulltext

Initial clinical experience using a novel Pd-103 surface ... Here we present our initial clinical experience with the first 2 cases using this new IORT technology to boost the tumor bed after preoperative RT.

4. civatechoncology.com civatechoncology.com/wp-content/uploads/2019/04/VCU-CivaSheet-sarcoma-trunk.pdf

The CivaSheet: The new frontier of intraoperative radiation ... The CivaSheet (CivaTech Oncology Inc., Durham, NC), an implantable unidirectional palladium-103 (Pd-103) planar low-dose brachytherapy device, overcomes many of ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37271655/

CivaSheet® use for soft tissue sarcoma: A single institution ... CivaSheet is a palladium-103, implantable, intraoperative radiation therapy device which emits unidirectional radiation that enables boost doses in patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7004947/

Report of the First Patient Treated for Pelvic Sarcoma With ... The present report describes this treatment approach and 3-year oncologic outcome of a patient with locally advanced leiomyosarcoma in the pelvic sidewall who ...

7. clinicaltrial.be clinicaltrial.be/en/details/62371?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&not_yet_recruiting=0&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Registry of Sarcoma Patients Treated With Permanently Imp... Sarcoma patients have up to 80% local recurrence rates, depending on histology and location of disease presentation. CivaSheet will be implanted ...