Intraoperative Radiation Therapy for Locally Advanced or Recurrent Abdomino-pelvic Solid Tumors With the CivaSheet
NCT ID: NCT02902107
Last Updated: 2024-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2016-09-09
2024-10-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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surgical resection and intraoperative radiation therapy (IORT)
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.
CivaSheet
Brachytherapy
surgical resection
Interventions
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CivaSheet
Brachytherapy
surgical resection
Eligibility Criteria
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Inclusion Criteria
* Maximum projected treatment length 15cm and width 5cm, which are the dimensions of the largest available CivaSheet
* Medically fit and willing to undergo resection of disease
* Age ≥ 18 years
* ECOG performance status 0, 1, or 2
* ANC ≥ 1.5 cells/mm3, PLT≥100,000/mm3, PT/aPTT within normal limits at time of surgery
* Life expectancy, in the clinician's judgment, greater than 1 year.
Exclusion Criteria
* 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
* Patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.
* Patients who, in the investigator's judgment, are unwilling or unable to consent to and return for recommended post-treatment scans as outlined in this study.
* Patients on concurrent anti-cancer therapy, unless specifically agreed to by the patient's medical oncologist and consenting professional.
* Patients with contraindications to general anesthesia, as determined by the treating physician or surgeon
18 Years
ALL
No
Sponsors
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CivaTech Oncology
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Abraham Wu, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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16-605
Identifier Type: -
Identifier Source: org_study_id
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