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

• Sponsor: University of Virginia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04499521
• Collaborator: BrachyFoam, LLC (Other)
• Enrollment: 45
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 33.5
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 45 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.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: Mar 17, 2021
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

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

Primary Outcome Measures

1. Highest dose of radiation (in Gy) to the rectum and bladder for each patient [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 [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 [Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy]

   This number (dose) is based on the radiation treatment plan

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia	Charlottesville	Virginia	United States	22903

Sponsors and Collaborators

• University of Virginia
• BrachyFoam, LLC

Investigators

• Principal Investigator: Kara Romano, University of Virginia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kara Romano, MD, Assistant Professor, University of Virginia
• ClinicalTrials.gov Identifier: NCT04499521
• Other Study ID Numbers: HSR 200128
• First Posted: Aug 5, 2020
• Last Update Posted: Jul 8, 2022
• Last Verified: Jul 1, 2022

• 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
• Keywords provided by Kara Romano, MD, Assistant Professor, University of Virginia: Brachytherapy
• Additional relevant MeSH terms: Uterine Cervical Neoplasms

Study Results

No Results Posted as of Jul 8, 2022