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Brachytherapy
Radiation Therapy with CivaSheet® for Sarcoma
Phase 4
Recruiting
Led By Krisha Howell, MD
Research Sponsored by CivaTech Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is able to undergo surgery
Sarcoma evident on imaging. Pathology biopsy proven or suspected by imaging but not a biopsy candidate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Summary
This trial will determine the safety and toxicity of a permanently implantable brachytherapy source, CivaSheet®, which delivers a therapeutic dose of low dose rate radiation with polymer encased Palladium-103.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include typical reactions associated with radiation therapy such as localized pain, swelling at implant site, infection risk increase around the surgical area where CivaSheet® is placed, and possible damage to nearby organs or tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fit for surgery.
Select...
My scans show sarcoma, confirmed by biopsy or suspected but not biopsied.
Select...
My sarcoma is located in my abdomen, pelvis, trunk, or behind my abdomen.
Select...
My scans show a sarcoma, confirmed by biopsy or suspected but not biopsied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of acute toxicity
Secondary study objectives
Complication rate
Dose to target and OAR
Local control rate
+1 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CivaSheet TreatmentExperimental Treatment1 Intervention
Implanted with CivaSheet during tumor removal
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CivaSheet
2016
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
TAB ClinicalUNKNOWN
1 Previous Clinical Trials
25 Total Patients Enrolled
CivaTech OncologyLead Sponsor
6 Previous Clinical Trials
206 Total Patients Enrolled
Krisha Howell, MDPrincipal InvestigatorFox Chase Cancer Center
1 Previous Clinical Trials
11 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fit for surgery.My scans show sarcoma, confirmed by biopsy or suspected but not biopsied.My sarcoma is located in my abdomen, pelvis, trunk, or behind my abdomen.My scans show a sarcoma, confirmed by biopsy or suspected but not biopsied.
Research Study Groups:
This trial has the following groups:- Group 1: CivaSheet Treatment
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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