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

University of Virginia21 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cervical Cancer

Interventions

BrachyGel VHPSDEVICE

Packing system for administering brachytherapy in cervical cancer patients

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

Dosimetry Comparison of Packing System in OARs

The mean difference in bladder and rectum doses between Gauze and BrachyGel for fractions 2 and 3

Time frame: Fractions 2 and 3 about 1 - 2 weeks after starting brachytherapy

Secondary Outcomes

Adverse Events

Frequency and intensity (CTCAE v5 grade) of AEs

Time frame: From the completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)

Dosimetry Comparison of Packing System in OARs

The mean difference in bladder and rectum doses between Gauze and BrachyGel for fractions 2 through 5.

Time frame: Fractions 2 and 5 about 1 - 4 weeks after starting brachytherapy

Data from ClinicalTrials.gov

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