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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of acute toxicity
Secondary outcome measures
Complication rate
Dose to target and OAR
Local control rate
+1 moreTrial 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
2017
Completed Phase 1
~10
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
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial currently have openings for participants?
"Affirmative. Clinicaltrials.gov data supports the notion that this clinical trial is still actively recruiting participants, with it being initially posted on April 30th 2020 and recently updated on March 1st 2022. At present, they are seeking 100 patients from 2 sites to join their study."
Answered by AI
Has CivaSheet been authorized by the Food and Drug Administration?
"The safety of CivaSheet has been confirmed in this Phase 4 trial, thus earning it a score of 3."
Answered by AI
What is the uppermost number of subjects involved in this research?
"Affirmative. According to information displayed on clinicaltrials.gov, this medical trial is presently looking for participants and was initially posted in April of 2020 before being updated most recently in March of 2022. It seeks 100 patients across two different sites."
Answered by AI
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