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

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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Device: BrachyGel VHPS

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Biopsy showing cancer of the cervix (squamous cell carcinoma, adenocarcinoma, adenosquamous, neuroendocrine, etc)
2. FIGO IB1 - IVB Staging according to FIGO and TNM guidelines
3. Planning to receive brachytherapy as a part of the definitive treatment for cervical cancer
4. Karnofsky performance status (KPS) ≥ 70 or ECOG status ≤1
5. Stated willingness to comply with all study procedures and availability for the duration of the study
6. Age ≥ 18 years
7. Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria:

1. History of pelvis or abdominal radiation therapy (RT) that is not a part of the definitive treatment plan for the cancer of interest"
2. History of total or partial hysterectomy
3. Plan to receive external beam RT (EBRT) alone as the definitive treatment plan for the cancer of interest
4. Known pregnancy or lactation (no pregnancy test required prior to participation)
5. Known contraindications to brachytherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: BrachyGel in fractions 3 and 5; BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4	Device: BrachyGel VHPS; Packing system for administering brachytherapy in cervical cancer patients
Experimental: Arm B: BrachyGel in fractions 2 and 4; BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5	Device: BrachyGel VHPS; Packing system for administering brachytherapy in cervical cancer patients

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Frequency and intensity (CTCAE v5 grade) of AEs	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.	Fractions 2 and 5 about 1 - 4 weeks after starting brachytherapy

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: BrachyFoam, LLC
• Investigators: Principal Investigator: Kara Romano, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Actual): December 9, 2022
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Brachytherapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: HSR 200128

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No