A Randomized, Non-Inferiority Study of a Hydrogel Packing System Compared to Standard of Care Packing During Image-Guided High-Dose Rate Brachytherapy Boost for Cervical Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Virginia
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Dosimetry Comparison of Packing System in OARs
Study Overview
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 away from radiation at least as well as the standard options, and to better understand the safety and patient discomfort associated with BrachyGel VHPS and the standard packing options.
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 available standard of care packing systems to move these unrelated organs out of the way can sometimes be uncomfortable for the patient, may not move all of the unrelated organs all the way out of the radiation's path, and rely on the doctor to place them correctly.
If you participate, you will receive 5 fractions of brachytherapy according to standard clinical care. For three of the fractions, a standard packing option will be used and for two of them BrachyGel VHPS will be used. For the first fraction both groups will have the same packing option but participants will be randomized to either have BrachyGel during fractions 2 and 4 or during fractions 3 and 5. You'll be asked to complete a questionnaire after fractions 2-5 to get your feedback on any discomfort you have during or after brachytherapy from the packing system.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Dosimetry Comparison of Packing System in OARs
Time Frame: Fractions 2 and 3 about 1 - 2 weeks after starting brachytherapy
The mean difference in bladder and rectum doses between Gauze and BrachyGel for fractions 2 and 3
Secondary Outcomes
- Adverse Events(From the completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days))
- Dosimetry Comparison of Packing System in OARs(Fractions 2 and 5 about 1 - 4 weeks after starting brachytherapy)
Investigators
Kara Romano, MD
Assistant Professor
University of Virginia