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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04499521
• Other study ID #: HSR 200128
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: September 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: June 1, 2024
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Device:
• BrachyGel VHPS
Packing system for administering brachytherapy in cervical cancer patients

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	BrachyFoam, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Highest dose of radiation (in Gy) to the rectum and bladder for each patient	This number (dose) is based on the radiation treatment plan	Fractions 2 and 3: About 1-2 weeks after starting brachytherapy
Secondary	Adverse Events	Frequency, intensity, and duration of adverse events	Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy
Secondary	Highest dose of radiation (in Gy) to the rectum and bladder for each patient at each treatment	This number (dose) is based on the radiation treatment plan	Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy