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A prospective, multicenter, open-label, single-arm clinical trial design to evaluate the safety and efficacy of (90)Y resin microspheres for the treatment of unresectable HCC: the DOORwaY90 (Duration Of Objective Response with arterial Ytrrium-90) study
BACKGROUND: Selective internal radiation therapy (SIRT) with yttrium-90 ((90)Y) resin microspheres is an established locoregional treatment option for unresectable hepatocellular carcinoma (HCC), which delivers a lethal dose of radiation to hepatic tumors, while sparing surrounding healthy tissue. D...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8962126/ https://www.ncbi.nlm.nih.gov/pubmed/35346070 http://dx.doi.org/10.1186/s12876-022-02204-1 |
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author | Mahvash, Armeen Chartier, Steven Turco, Mark Habib, Paula Griffith, Steven Brown, Scott Kappadath, S. Cheenu |
author_facet | Mahvash, Armeen Chartier, Steven Turco, Mark Habib, Paula Griffith, Steven Brown, Scott Kappadath, S. Cheenu |
author_sort | Mahvash, Armeen |
collection | PubMed |
description | BACKGROUND: Selective internal radiation therapy (SIRT) with yttrium-90 ((90)Y) resin microspheres is an established locoregional treatment option for unresectable hepatocellular carcinoma (HCC), which delivers a lethal dose of radiation to hepatic tumors, while sparing surrounding healthy tissue. DOORwaY90 is a prospective, multicenter, open-label, single arm study, designed to evaluate the safety and effectiveness of (90)Y resin microspheres as first-line treatment in patients with unresectable/unablatable HCC. It is unique in that it is the first study with resin microspheres to utilize a personalized (90)Y dosimetry approach, and independent review for treatment planning and response assessment. METHODS: Eligibility criteria include unresectable/unablatable HCC, Barcelona Clinic Liver Cancer stage A, B1, B2, or C with a maximal single tumor diameter of ≤ 8 cm, and a sum of maximal tumor diameters of ≤ 12 cm, and at least one tumor ≥ 2 cm (long axis) per localized, modified Response Evaluation Criteria in Solid Tumors. Partition model dosimetry is used to determine the optimal dose; the target mean dose to tumor is ≥ 150 Gy. Patients are assessed at baseline and at regular intervals up until 12 months of treatment for response rates, safety, and quality of life (QoL). Post-treatment dosimetry is used to assess dose delivered to tumor and consider if retreatment is necessary. The co-primary endpoints are best objective response rate and duration of response. Secondary endpoints include grade ≥ 3 toxicity, QoL, and incidence of liver resection and transplantation post SIRT. Target recruitment is 100 patients. DISCUSSION: The results of this trial should provide further information on the potential use of SIRT with (90)Y resin microspheres as first-line therapy for unresectable HCC. TRIAL REGISTRATION: Clinicaltrials.gov; NCT04736121; date of 1st registration, January 27, 2021, https://clinicaltrials.gov/ct2/show/NCT04736121. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12876-022-02204-1. |
format | Online Article Text |
id | pubmed-8962126 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-89621262022-03-30 A prospective, multicenter, open-label, single-arm clinical trial design to evaluate the safety and efficacy of (90)Y resin microspheres for the treatment of unresectable HCC: the DOORwaY90 (Duration Of Objective Response with arterial Ytrrium-90) study Mahvash, Armeen Chartier, Steven Turco, Mark Habib, Paula Griffith, Steven Brown, Scott Kappadath, S. Cheenu BMC Gastroenterol Study Protocol BACKGROUND: Selective internal radiation therapy (SIRT) with yttrium-90 ((90)Y) resin microspheres is an established locoregional treatment option for unresectable hepatocellular carcinoma (HCC), which delivers a lethal dose of radiation to hepatic tumors, while sparing surrounding healthy tissue. DOORwaY90 is a prospective, multicenter, open-label, single arm study, designed to evaluate the safety and effectiveness of (90)Y resin microspheres as first-line treatment in patients with unresectable/unablatable HCC. It is unique in that it is the first study with resin microspheres to utilize a personalized (90)Y dosimetry approach, and independent review for treatment planning and response assessment. METHODS: Eligibility criteria include unresectable/unablatable HCC, Barcelona Clinic Liver Cancer stage A, B1, B2, or C with a maximal single tumor diameter of ≤ 8 cm, and a sum of maximal tumor diameters of ≤ 12 cm, and at least one tumor ≥ 2 cm (long axis) per localized, modified Response Evaluation Criteria in Solid Tumors. Partition model dosimetry is used to determine the optimal dose; the target mean dose to tumor is ≥ 150 Gy. Patients are assessed at baseline and at regular intervals up until 12 months of treatment for response rates, safety, and quality of life (QoL). Post-treatment dosimetry is used to assess dose delivered to tumor and consider if retreatment is necessary. The co-primary endpoints are best objective response rate and duration of response. Secondary endpoints include grade ≥ 3 toxicity, QoL, and incidence of liver resection and transplantation post SIRT. Target recruitment is 100 patients. DISCUSSION: The results of this trial should provide further information on the potential use of SIRT with (90)Y resin microspheres as first-line therapy for unresectable HCC. TRIAL REGISTRATION: Clinicaltrials.gov; NCT04736121; date of 1st registration, January 27, 2021, https://clinicaltrials.gov/ct2/show/NCT04736121. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12876-022-02204-1. BioMed Central 2022-03-28 /pmc/articles/PMC8962126/ /pubmed/35346070 http://dx.doi.org/10.1186/s12876-022-02204-1 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Mahvash, Armeen Chartier, Steven Turco, Mark Habib, Paula Griffith, Steven Brown, Scott Kappadath, S. Cheenu A prospective, multicenter, open-label, single-arm clinical trial design to evaluate the safety and efficacy of (90)Y resin microspheres for the treatment of unresectable HCC: the DOORwaY90 (Duration Of Objective Response with arterial Ytrrium-90) study |
title | A prospective, multicenter, open-label, single-arm clinical trial design to evaluate the safety and efficacy of (90)Y resin microspheres for the treatment of unresectable HCC: the DOORwaY90 (Duration Of Objective Response with arterial Ytrrium-90) study |
title_full | A prospective, multicenter, open-label, single-arm clinical trial design to evaluate the safety and efficacy of (90)Y resin microspheres for the treatment of unresectable HCC: the DOORwaY90 (Duration Of Objective Response with arterial Ytrrium-90) study |
title_fullStr | A prospective, multicenter, open-label, single-arm clinical trial design to evaluate the safety and efficacy of (90)Y resin microspheres for the treatment of unresectable HCC: the DOORwaY90 (Duration Of Objective Response with arterial Ytrrium-90) study |
title_full_unstemmed | A prospective, multicenter, open-label, single-arm clinical trial design to evaluate the safety and efficacy of (90)Y resin microspheres for the treatment of unresectable HCC: the DOORwaY90 (Duration Of Objective Response with arterial Ytrrium-90) study |
title_short | A prospective, multicenter, open-label, single-arm clinical trial design to evaluate the safety and efficacy of (90)Y resin microspheres for the treatment of unresectable HCC: the DOORwaY90 (Duration Of Objective Response with arterial Ytrrium-90) study |
title_sort | prospective, multicenter, open-label, single-arm clinical trial design to evaluate the safety and efficacy of (90)y resin microspheres for the treatment of unresectable hcc: the doorway90 (duration of objective response with arterial ytrrium-90) study |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8962126/ https://www.ncbi.nlm.nih.gov/pubmed/35346070 http://dx.doi.org/10.1186/s12876-022-02204-1 |
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