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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 22, 2020
First Posted Date  ICMJE August 5, 2020
Last Update Posted Date January 20, 2023
Actual Study Start Date  ICMJE March 17, 2021
Actual Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2021)		 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2021)
  • Adverse Events [ Time Frame: Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy ]
    Frequency, intensity, and duration of adverse events
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Cervical Cancer
Intervention  ICMJE Device: BrachyGel VHPS
Packing system for administering brachytherapy in cervical cancer patients
Study Arms  ICMJE
  • Experimental: Arm A: BrachyGel in fractions 3 and 5
    BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
    Intervention: Device: BrachyGel VHPS
  • Experimental: Arm B: BrachyGel in fractions 2 and 4
    BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
    Intervention: Device: BrachyGel VHPS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 19, 2023)		 21
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE January 1, 2024
Actual Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04499521
Other Study ID Numbers  ICMJE HSR 200128
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kara Romano, MD, University of Virginia
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE University of Virginia
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE BrachyFoam, LLC
Investigators  ICMJE
Principal Investigator: Kara Romano University of Virginia
PRS Account University of Virginia
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP