Radiation Therapy with CivaSheet® for Sarcoma
Recruiting in Palo Alto (17 mi)
+1 other location
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: CivaTech Oncology
Disqualifiers: Pregnancy, Breastfeeding, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
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?
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
Trial 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 (Brachytherapy)
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
Research Locations NearbySelect from list below to view details:
Fox Chase Cancer CenterPhiladelphia, PA
Rush University Cancer CenterChicago, IL
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Who Is Running the Clinical Trial?
CivaTech OncologyLead Sponsor
TAB ClinicalCollaborator
References
[Brachytherapy in soft tissue sarcomas]. [2019]Soft tissue sarcomas are rare tumors with a high risk or local recurrence and a risk of distant metastases. Standard treatment advocated is the combination of conservative resection and external radiotherapy. Brachytherapy is an integrated part of the multidisciplinary treatment. Brachytherapy can increase local control with good functional results. Primary exclusive brachytherapy has been used and is effective and safe in high grade sarcomas (randomized trial of MSKCC). Brachytherapy seems to be important as part of the treatment of central localization (shoulder, groin) and sarcomas with positive resection margins, but its relation with external radiotherapy has to be defined. Brachytherapy used with special guidelines allows to obtain an improved local control with an acceptable level of complication.
High-dose-rate brachytherapy for soft tissue sarcoma in children: a single institution experience. [2021]To report our experience treating soft tissue sarcoma (STS) with high dose rate brachytherapy alone (HBRT) or in combination with external beam radiotherapy (EBRT) in pediatric patients.
Current results of brachytherapy for soft tissue sarcoma. [2019]Perioperative brachytherapy results in a better local control rate than surgery alone for extremity soft tissue sarcoma. Brachytherapy enables the delivery of a high radiation dose to a limited volume of tissue, allows the reduction of radiation treatment time, enables direct visualization of the tumor bed and surrounding critical structures, and costs less than external beam radiotherapy. The literature seems to regard the effectiveness of brachytherapy as comparable to that of external beam radiotherapy, and the side effect profile is acceptable. Traditional low-dose-rate brachytherapy methods require extended periods of patient isolation, but recent technologic advances may obviate this necessity. Newer high-dose-rate (HDR) brachytherapy delivery methods allow for the fractionation of radiation delivery and outpatient treatment in some cases. Furthermore, with HDR brachytherapy, the radiation dose distribution can be tailored around critical anatomic structures. Although the application of HDR brachytherapy to soft tissue sarcoma is relatively new, it seems to result in a satisfactory local control rate and may replace traditional low-dose-rate techniques.
Flap reconstruction and interstitial brachytherapy in nonextremity soft tissue sarcoma. [2019]Radiotherapy is an integral component of management of high-grade soft tissue sarcomas. Interstitial brachytherapy is used to deliver a boost or radical dose with several advantages over external beam radiotherapy. There has always been a concern to use brachytherapy with flap reconstruction of skin defects after wide excision. We preset our initial experience with interstitial brachytherapy in two patients of recurrent high-grade non-extremity sarcomas treated with surgical excision and soft tissue reconstruction of surgical defect.
Brachytherapy for Organ and Function Preservation in Soft-Tissue Sarcomas in Adult and Paediatric Patients. [2023]Adjuvant radiotherapy is an integral component in the management of soft-tissue sarcomas. Brachytherapy is a very convenient and conformal way of delivering adjuvant radiotherapy in such tumours, which spares the surrounding normal tissue. Randomised studies have established the efficacy of brachytherapy in the adjuvant setting, with a 5-year local control of 80-85%. High dose rate, low dose rate and pulsed dose rate have shown equivalent local control, but high dose rate has gained popularity owing to patient convenience, radiation safety and flexibility in dose optimisation. Freehand insertion perioperative brachytherapy (intraoperative placement and postoperative treatment) is the most commonly used technique in soft-tissue sarcomas, with intraoperative radiotherapy and radioactive seed placement being the less commonly used techniques. Brachytherapy can be used as monotherapy or in combination with external beam radiotherapy, such as in cases of close/positive margins for safe dose escalation. Although the quantum of side-effects with external beam radiotherapy has considerably reduced with the evolution of technology and the introduction of intensity modulation (intensity-modulated radiotherapy), brachytherapy still scores better in terms of dose conformality, especially in recurrent tumours (previously irradiated) and when used to treat paediatric and geriatric patients.
CivaSheet® use for soft tissue sarcoma: A single institution experience. [2023]CivaSheet is a palladium-103, implantable, intraoperative radiation therapy device which emits unidirectional radiation that enables boost doses in patients who have otherwise received the maximum radiation dose. Here, we present our initial clinical experience with the first 10 cases using this new technology.
Intraoperative implantation of a mesh of directional palladium sources (CivaSheet): Dosimetry verification, clinical commissioning, dose specification, and preliminary experience. [2018]Label="PURPOSE">To present the clinical commissioning of a novel 103Pd directional brachytherapy device (CivaSheet) for intraoperative radiation therapy.
CivaSheet intraoperative radiation therapy for pancreatic cancer. [2022]The treatment of borderline resectable (BR) pancreatic cancer is challenging and requires a multidisciplinary approach with chemotherapy, radiation and surgical resection. Despite using chemotherapy and radiotherapy in the neoadjuvant setting, achievement of negative surgical margins remains technically challenging. Positive margins are associated with increased local recurrences and worse overall survival and there are no standard options for treatment. The CivaSheet is an FDA-cleared implantable sheet with a matrix of unidirectional planar low-dose-rate (LDR) Palladium-103 (Pd-103) sources. The sources are shielded on one side with gold to spare radio-sensitive structures such as the bowel. The sheet can easily be customized and implanted at the time of surgery when there is concern for close or positive margins. The CivaSheet provides an interesting solution to target the region of close/positive margins after pancreatectomy. Here we discuss the physical properties, the dosimetry, clinical workflow and early patient outcomes with the CivaSheet in pancreatic cancer.
A directional 103Pd brachytherapy device: Dosimetric characterization and practical aspects for clinical use. [2018]Label="PURPOSE">A brachytherapy (BT) device has been developed with shielding to provide directional BT for preferentially irradiating malignancies while sparing healthy tissues. The CivaSheet is a flexible low-dose-rate BT device containing CivaDots with 103Pd shielded by a thin Au disk. This is the first report of a clinical dosimetric characterization of the CivaSheet device.
Dosimetric characterization of a new directional low-dose rate brachytherapy source. [2020]Label="PURPOSE" NlmCategory="OBJECTIVE">CivaTech Oncology Inc. (Durham, NC) has developed a novel low-dose rate (LDR) brachytherapy source called the CivaSheet.TM The source is a planar array of discrete elements ("CivaDots") which are directional in nature. The CivaDot geometry and design are considerably different than conventional LDR cylindrically symmetric sources. Thus, a thorough investigation is required to ascertain the dosimetric characteristics of the source. This work investigates the repeatability and reproducibility of a primary source strength standard for the CivaDot and characterizes the CivaDot dose distribution by performing in-phantom measurements and Monte Carlo (MC) simulations. Existing dosimetric formalisms were adapted to accommodate a directional source, and other distinguishing characteristics including the presence of gold shield x-ray fluorescence were addressed in this investigation.
Application of a directional palladium-103 brachytherapy device on a curved surface. [2019]Label="PURPOSE" NlmCategory="OBJECTIVE">The directional planar palladium-103 LDR device (CivaSheet TM ) may be used for intraoperative implantation at the interface between the tumor site and healthy tissue. Its dosimetric properties have been studied in the ideal case of application on a flat surface. The dosimetric impact of implanting this highly directional device on a curved surface that may be encountered in clinical treatments is analyzed.
[Comparison of intensity-modulated postoperative radiotherapy with conventional postoperative conformal radiotherapy for retroperitoneal sarcoma]. [2016]External postoperative radiation therapy for retroperitoneal sarcoma is an example of treatment using large fields for complex shaped volumes of irradiation. Prescribed dose is limited by tolerance of adjacent organs at risk (OAR). From a recent case treated by conventional conformal radiotherapy (3D-CRT), we evaluate the benefit of five theoretical IMRT plans. Criteria used are calculated from DVH related to delineated PTV and OAR. IMRT should permit to enhance the prescribed dose without increasing dose in the OAR (especially residual kidney, spinal cord and small bowel). This theoretical study show the feasibility of a dose escalation from a treatment dose of 45 Gy delivered by 3D-CRT up to a planning dose of 54 Gy calculated by IMRT with: for the PTV: an improvement of the dose homogeneity about 5% (range 2-6%) and moreover the coverage factor (CF) about 13% (range 9-16%); for the OAR: an improvement of the protection factor (PF) about 20% (range 11-24%); and thus an improved conformity index (CI = CF x PF) about 25% (range 15-32%).