A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer
Primary Purpose
Cervical Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BrachyGel VHPS
Sponsored by
About this trial
This is an interventional supportive care trial for Cervical Cancer focused on measuring Brachytherapy
Eligibility Criteria
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
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A: BrachyGel in fractions 3 and 5
Arm B: BrachyGel in fractions 2 and 4
Arm Description
BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
Outcomes
Primary Outcome Measures
Highest dose of radiation (in Gy) to the rectum and bladder for each patient
This number (dose) is based on the radiation treatment plan
Secondary Outcome Measures
Adverse Events
Frequency, intensity, and duration of adverse events
Highest dose of radiation (in Gy) to the rectum and bladder for each patient at each treatment
This number (dose) is based on the radiation treatment plan
Full Information
NCT ID
NCT04499521
First Posted
July 22, 2020
Last Updated
September 7, 2023
Sponsor
University of Virginia
Collaborators
BrachyFoam, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04499521
Brief Title
A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
BrachyFoam, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Brachytherapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both groups will have two fractions of brachytherapy with a standard packing system and two fractions of brachytherapy with BrachyGel VHPS - only the timing will be different between the two groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: BrachyGel in fractions 3 and 5
Arm Type
Experimental
Arm Description
BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
Arm Title
Arm B: BrachyGel in fractions 2 and 4
Arm Type
Experimental
Arm Description
BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
Intervention Type
Device
Intervention Name(s)
BrachyGel VHPS
Intervention Description
Packing system for administering brachytherapy in cervical cancer patients
Primary Outcome Measure Information:
Title
Highest dose of radiation (in Gy) to the rectum and bladder for each patient
Description
This number (dose) is based on the radiation treatment plan
Time Frame
Fractions 2 and 3: About 1-2 weeks after starting brachytherapy
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Frequency, intensity, and duration of adverse events
Time Frame
Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy
Title
Highest dose of radiation (in Gy) to the rectum and bladder for each patient at each treatment
Description
This number (dose) is based on the radiation treatment plan
Time Frame
Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kara Romano
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer
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