N/A
Completed N=21
A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer
Source: ClinicalTrials.gov NCT04499521 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Dosimetry Comparison of Packing System in OARs — 3.436; 3.319; 3.636; 3.573 Mean in Dose (Gray)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dosimetry Comparison of Packing System in OARs |
3.436; 3.319; 3.287; 3.798; 3.636; 3.573 | — |
| SECONDARY Adverse Events |
2; 0; 2; 0; 0; 3 | — |
| SECONDARY Dosimetry Comparison of Packing System in OARs |
3.436; 3.319; 3.287; 3.798; 3.636; 3.573 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04499521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.