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NCT Number: NCT04499521

A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BrachyGel VHPS

Device

Packing system for administering brachytherapy in cervical cancer patients

Primary outcomes

  1. 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

  1. Adverse Events

    Time frame: From the completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)

    Frequency and intensity (CTCAE v5 grade) of AEs

  2. Dosimetry Comparison of Packing System in OARs

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

    The mean difference in bladder and rectum doses between Gauze and BrachyGel for fractions 2 through 5.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • BrachyFoam, LLC

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Aug 5, 2020
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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