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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Device: BrachyGel VHPS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy showing cancer of the cervix (squamous cell carcinoma, adenocarcinoma, adenosquamous, neuroendocrine, etc) FIGO IB1 - IVB Staging according to FIGO and TNM guidelines Planning to receive brachytherapy as a part of the definitive treatment for cervical cancer Karnofsky performance status (KPS) ≥ 70 or ECOG status ≤1 Stated willingness to comply with all study procedures and availability for the duration of the study Age ≥ 18 years Agreement to adhere to Lifestyle Considerations throughout study duration Exclusion Criteria: History of pelvis or abdominal radiation therapy (RT) that is not a part of the definitive treatment plan for the cancer of interest History of total or partial hysterectomy Plan to receive external beam RT (EBRT) alone as the definitive treatment plan for the cancer of interest Known pregnancy or lactation (no pregnancy test required prior to participation) Known contraindications to brachytherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: BrachyGel in fractions 3 and 5<br>BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4 | Device: BrachyGel VHPS<br>* Packing system for administering brachytherapy in cervical cancer patients<br>|
| Experimental: Arm B: BrachyGel in fractions 2 and 4<br>BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5 | Device: BrachyGel VHPS<br>* Packing system for administering brachytherapy in cervical cancer patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | 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 | This number (dose) is based on the radiation treatment plan | Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brachytherapy