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Trial record 1 of 1 for:    NCT04499521
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A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer

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ClinicalTrials.gov Identifier: NCT04499521
Recruitment Status : Active, not recruiting
First Posted : August 5, 2020
Last Update Posted : January 20, 2023
Sponsor:
Collaborator:
BrachyFoam, LLC
Information provided by (Responsible Party):
Kara Romano, MD, University of Virginia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Device: BrachyGel VHPS Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
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
Actual Study Start Date : March 17, 2021
Actual Primary Completion Date : September 30, 2022
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy ]
    Frequency, intensity, and duration of adverse events

  2. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04499521


Locations
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United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
BrachyFoam, LLC
Investigators
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Principal Investigator: Kara Romano University of Virginia
More Information
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Responsible Party: Kara Romano, MD, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT04499521    
Other Study ID Numbers: HSR 200128
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kara Romano, MD, University of Virginia:
Brachytherapy
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases