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Brachytherapy
Intraoperative Radiation Therapy for Abdomino-pelvic Cancer
Phase 1
Waitlist Available
Led By Abraham Wu, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0, 1, or 2
Age ≥ 18 years
Must not have
Women who are pregnant
Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy after the receipt of brachytherapy. Male subjects must also agree to use effective contraception during the treatment period and until 1 year after the completion of brachytherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
This trialtests a new device for radiation therapy (IORT) during surgery for abdominal/pelvic tumors. It may offer better treatment with fewer side effects. Success could mean wider availability.
Who is the study for?
Adults with a life expectancy over 1 year and advanced or recurrent abdominal/pelvic solid tumors suitable for surgery can join. They must be in decent health, not pregnant, agree to use contraception, and have certain blood counts within normal ranges.Check my eligibility
What is being tested?
The trial is testing the CivaSheet device during surgery for treating abdominal and pelvic cancers. It's an FDA-approved intraoperative radiation therapy that could become a more common treatment if this pilot study shows it's easy to use and effective.See study design
What are the potential side effects?
Possible side effects of using the CivaSheet may include typical risks associated with radiation therapy such as skin irritation, fatigue, localized pain or discomfort post-surgery, but specific side effects will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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I am healthy enough and agree to have surgery to remove my disease.
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My cancer in the abdomen or pelvis needs surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently pregnant.
Select...
I am using, or willing to use, effective birth control during and up to one year after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
number of successful implantation of the device in patients
Trial Design
1Treatment groups
Experimental Treatment
Group I: surgical resection and intraoperative radiation therapy (IORT)Experimental Treatment3 Interventions
Brachytherapy will be administered using the CivaSheet, a novel permanent LDR palladium-103 (Pd-103) planar brachytherapy device that is applied directly to the surgical resection bed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CivaSheet
2017
Completed Phase 1
~10
Brachytherapy
2007
Completed Phase 3
~2100
surgical resection
2016
Completed Phase 3
~280
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
589,737 Total Patients Enrolled
CivaTech OncologyIndustry Sponsor
6 Previous Clinical Trials
292 Total Patients Enrolled
Abraham Wu, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
80 Total Patients Enrolled
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