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

NCT04499521 | Completed Results DMC FDA Device

• 1 other identifier: HSR 200128
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

Brachytherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Arm A: BrachyGel in fractions 3 and 5

EXPERIMENTAL

BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4

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

Device: BrachyGel VHPS

Interventions

BrachyGel VHPS DEVICE

Packing system for administering brachytherapy in cervical cancer patients

Arm A: BrachyGel in fractions 3 and 5; Arm B: BrachyGel in fractions 2 and 4

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• BrachyFoam, LLC: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Kara Romano, MD
• Organization: University of Virginia

ked7c@uvahealth.org

434-982-6278

Study Officials

• Kara Romano

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 5, 2020
• Study Start: March 17, 2021
• Primary Completion: December 9, 2022
• Study Completion: October 31, 2024
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2025-03

Locations

US (1)