Clinical trial · Interventional
A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BrachyGel VHPS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: BrachyGel in fractions 3 and 5
- description
- BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
- interventionNames
- Device: BrachyGel VHPS
- type
- EXPERIMENTAL
- label
- Arm B: BrachyGel in fractions 2 and 4
- description
- BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
- interventionNames
- Device: BrachyGel VHPS
Primary outcomes (1)
- measure
- Dosimetry Comparison of Packing System in OARs
- timeFrame
- Fractions 2 and 3 about 1 - 2 weeks after starting brachytherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available