A randomized trial evaluating a novel hydrogel packing system compared to standard packing during image-guided high-dose rate brachytherapy boost for cervical cancer.

Autor:	Romano KD; Department of Radiation Oncology, University of Virginia, Charlottesville, Virginia, USA. Electronic address: ked7c@virginia.edu., Petroni G; School of Public Health Sciences, Division of Biostatistics, University of Virginia, Charlottesville, Virginia, USA., Ward K; Department of Radiation Oncology, Emory University, Atlanta, Georgia, USA., Zheng W; Department of Radiation Oncology, University of Virginia, Charlottesville, Virginia, USA., Mistro M; Department of Radiation Oncology, University of Virginia, Charlottesville, Virginia, USA., Libby B; H. Lee Moffitt Cancer Center, Department of Radiation Oncology, Tampa, Florida, USA., McLaughlin C; Department of Radiation Oncology, University of Virginia, Charlottesville, Virginia, USA., Showalter TN; Department of Radiation Oncology, University of Virginia, Charlottesville, Virginia, USA., Janowski EM; Department of Radiation Oncology, University of Virginia, Charlottesville, Virginia, USA.
Jazyk:	angličtina
Zdroj:	Brachytherapy [Brachytherapy] 2024 May-Jun; Vol. 23 (3), pp. 248-256. Date of Electronic Publication: 2024 Mar 21.
DOI:	10.1016/j.brachy.2024.02.004
Abstrakt:	Introduction: The purpose of this prospective randomized trial was to compare the use of a novel vaginal hydrogel packing system (BrachyGel) to standard vaginal packing (VP) during high dose rate (HDR) brachytherapy (BT) for locally advanced cervical cancer (LACC). Methods: This cross-over study included LACC patients receiving HDR BT boost (intracavitary +/- interstitial). All patients received alternating gauze or BrachyGel VP on Arms A and B. Patients, physicians, and physicists evaluated BT characteristics via a 4-point Likert scale. Adverse events (AEs) were prospectively collected and scored per CTCAE. Results: The 20 patients enrolled. The mean bladder D2cc difference between gauze and BrachyGel in Arm A was 0.117 Gray (Gy) and in Arm B 0.013 Gy. The mean difference in rectum D2cc in Arm A and Arm B was -0.189 Gy and -0.191 Gy, respectively. The mean dose to 90% of the high-risk clinical target volume (HR-CTV) for gauze compared to BrachyGel was -0.032 Gy (95% CI: 0.472, 0.409). Patient-reported discomfort was similar with BrachyGel and gauze ("mild/moderate" 70.0% vs 74.0%, respectively). The clarity of VP was similar between BrachyGel and gauze (86.8% vs 89.7%, respectively). The completeness of VP was more frequently "excellent/good" with BrachyGel (79.0%) compared to gauze (56.4%). The ease of packing was more frequently "extremely easy" with BrachyGel (21.2% vs 0%). No serious AEs were reported. Conclusion: This randomized trial found no clinically significant difference in OAR or HR-CTV dosimetry between BrachyGel and standard VP. BrachyGel performed well compared to gauze for the patient and physician use experience. (Copyright © 2024 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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