Status:
COMPLETED
A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
BrachyFoam, LLC
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
In this study, a new, low cost packing system ("BrachyGel VHPS") is being tested as a packing option during brachytherapy along with standard options to make sure that it keeps the unrelated organs aw...
Detailed Description
As part of vaginal brachytherapy, the organs that do not need to receive radiation (unrelated organs) are moved out of the way of the radiation with a "packing system". The usual low cost and availabl...
Eligibility Criteria
Inclusion
- Biopsy showing cancer of the cervix (squamous cell carcinoma, adenocarcinoma, adenosquamous, neuroendocrine, etc)
- FIGO IB1 - IVB Staging according to FIGO and TNM guidelines
- Planning to receive brachytherapy as a part of the definitive treatment for cervical cancer
- Karnofsky performance status (KPS) ≥ 70 or ECOG status ≤1
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥ 18 years
- Agreement to adhere to Lifestyle Considerations throughout study duration
Exclusion
- History of pelvis or abdominal radiation therapy (RT) that is not a part of the definitive treatment plan for the cancer of interest"
- History of total or partial hysterectomy
- Plan to receive external beam RT (EBRT) alone as the definitive treatment plan for the cancer of interest
- Known pregnancy or lactation (no pregnancy test required prior to participation)
- Known contraindications to brachytherapy
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04499521
Start Date
March 17 2021
End Date
October 31 2024
Last Update
March 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Virginia
Charlottesville, Virginia, United States, 22903