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

September 7, 2023 updated by: Kara Romano, MD, University of Virginia

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

Active, not recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Highest dose of radiation (in Gy) to the rectum and bladder for each patient
Time Frame: Fractions 2 and 3: About 1-2 weeks after starting brachytherapy
This number (dose) is based on the radiation treatment plan
Fractions 2 and 3: About 1-2 weeks after starting brachytherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy
Frequency, intensity, and duration of adverse events
Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy
Highest dose of radiation (in Gy) to the rectum and bladder for each patient at each treatment
Time Frame: Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy
This number (dose) is based on the radiation treatment plan
Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

BrachyFoam, LLC

Investigators

  • Principal Investigator: Kara Romano, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Estimated)

June 1, 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)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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