Cervical CancerNCT04499521

A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer

A study testing BrachyGel VHPS in people with Cervical Cancer, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Cervical Cancer
What is being tested?: BrachyGel VHPS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 17 Mar 2021to 31 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia
Charlottesville, Virginia, 22903

Other trials in United States

About this study

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

Read the 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.

Conditions: Cervical Cancer
Being tested: BrachyGel VHPS
Keywords: Brachytherapy
Medical subject headings: Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BrachyGel VHPSDevice
Packing system for administering brachytherapy in cervical cancer patients

Study groups in NCT04499521
Study group	Role	What they receive
Arm A: BrachyGel in fractions 3 and 5	Experimental	BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4 Receives: Device: BrachyGel VHPS
Arm B: BrachyGel in fractions 2 and 4	Experimental	BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5 Receives: Device: BrachyGel VHPS

What is being measured

The primary outcome is the main question the study is designed to answer.

Dosimetry Comparison of Packing System in OARs
The mean difference in bladder and rectum doses between Gauze and BrachyGel for fractions 2 and 3
Measured: Fractions 2 and 3 about 1 - 2 weeks after starting brachytherapy

Secondary outcomes (2)

Adverse Events
Frequency and intensity (CTCAE v5 grade) of AEs
Measured: 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
The mean difference in bladder and rectum doses between Gauze and BrachyGel for fractions 2 through 5.
Measured: Fractions 2 and 5 about 1 - 4 weeks after starting brachytherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Mar 202131 Oct 2024

First posted5 Aug 2020
Study start17 Mar 2021
Primary completion9 Dec 2022
Study completion31 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cervical CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04499521
Sponsor's protocol ID: HSR 200128
Status last verified: Mar 2025
First submitted: 22 Jul 2020
Last updated: 17 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04499521
Acronym / sponsor ID: HSR 200128
Conditions: Cervical Cancer
Keywords: Brachytherapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Collaborators: BrachyFoam, LLC
Study start: 17 Mar 2021 (actual)
Primary completion: 9 Dec 2022 (actual)
Study completion: 31 Oct 2024 (actual)
First posted: 5 Aug 2020 (actual)
Results: Posted 17 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Arm A: BrachyGel in fractions 3 and 5	Experimental	Device: BrachyGel VHPSBrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
Arm B: BrachyGel in fractions 2 and 4	Experimental	Device: BrachyGel VHPSBrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BrachyGel VHPSPacking system for administering brachytherapy in cervical cancer patients	Device	Arm A: BrachyGel in fractions 3 and 5, Arm B: BrachyGel in fractions 2 and 4

Primary outcome

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

2 secondary outcomes

Adverse Events
Time frame: 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
Time frame: Fractions 2 and 5 about 1 - 4 weeks after starting brachytherapy

Results and safety

Results posted to the registry on 17 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: BrachyGel in Fractions 3 and 5	11	10
Arm B: BrachyGel in Fractions 2 and 4	10	10

Primary outcome: Dosimetry Comparison of Packing System in OARs

Time frame: Fractions 2 and 3 about 1 - 2 weeks after starting brachytherapy. Mean (Standard Deviation). Unit: Mean in Dose (Gray)

Measure	ARM A Fraction 2 n = 10	ARM A Fraction 3 n = 10	ARM B Fraction 2 n = 9	ARM B Fraction 3 n = 10
Bladder D2cc	3.436 (0.684)	3.319 (0.586)	3.636 (0.772)	3.573 (0.791)
Rectum D2cc	3.071 (0.386)	3.26 (0.357)	3.211 (0.693)	3.03 (0.722)
Bladder D1cc	3.745 (0.774)	3.601 (0.586)	4.026 (0.845)	3.908 (0.828)
Rectum D1cc	3.417 (0.492)	3.591 (0.405)	3.51 (0.789)	3.316 (0.812)
Bladder D0.1cc	4.457 (1.035)	4.311 (0.78)	4.911 (1.018)	4.705 (0.916)
Rectum D0.1cc	4.117 (0.713)	4.34 (0.681)	4.381 (1.06)	4.028 (1.134)
HR-CTVD90	6.518 (1.313)	6.638 (0.901)	5.917 (0.893)	6.575 (0.869)

ARM A Fraction 2 vs ARM A Fraction 3: Median Difference (Final Values): 0.12 (95% CI -0.27 to 0.50)
ARM B Fraction 2 vs ARM B Fraction 3: Median Difference (Final Values): 0.01 (95% CI -0.94 to 0.96)
ARM A Fraction 2 vs ARM A Fraction 3: Mean Difference (Final Values): -0.19 (95% CI -0.54 to 0.16)

Population analysed: 19 participants were evaluated. A major protocol deviation that occurred for one ARM B subject during fraction (Fx) 2 of brachytherapy (use of an incorrect packing method). This subject is not included in the analysis of this endpoint.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BrachyGel for Arm A	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Gauze for Arm A	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Other for Arm A	0 of 10 (0%)	5 of 10 (50%)	0 of 10
BrachyGel for Arm B	0 of 10 (0%)	5 of 10 (50%)	0 of 10
Gauze for Arm B	0 of 10 (0%)	3 of 10 (30%)	0 of 10
Other for Arm B	0 of 10 (0%)	6 of 10 (60%)	0 of 10

Limitations and caveats (from the sponsor): The limitations of this study include unblinded participants, lack of MRI for treatment planning, and a smaller than planned sample size. The study was designed as a non-inferiority trial with a planned accrual of 40 participants (20 per arm); however, the trial accrued 20 participants. No formal statistical significance calculations were performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kara Romano principal investigator

University of Virginia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BrachyGel VHPS in people with Cervical Cancer, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dosimetry Comparison of Packing System in OARs (time frame: Fractions 2 and 3 about 1 - 2 weeks after starting brachytherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04499521.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.