Proton Image-guided Radiation Assignment for Therapeutic Escalation via Selection of locally advanced head and neck cancer patients [PIRATES]: A Phase I safety and feasibility trial of MRI-guided adaptive particle radiotherapy

Introduction: Radiation dose-escalation for head and neck cancer (HNC) patients aiming to improve cure rates is challenging due to the increased risk of unacceptable treatment-induced toxicities. With “Proton Image-guided Radiation Assignment for Therapeutic Escalation via Selection of locally advan...

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Autores principales:	Lisanne V. van Dijk, Steven J. Frank, Ying Yuan, Brandon Gunn, Amy C. Moreno, Abdallah S.R. Mohamed, Kathryn E. Preston, Yun Qing, Michael T. Spiotto, William H. Morrison, Anna Lee, Jack Phan, Adam S. Garden, David I. Rosenthal, Johannes A. Langendijk, Clifton D. Fuller
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2022
Materias:	Head and neck cancer Radiation dose-escalation Proton therapy Image guided RT Hyper-fractionation Phase I trial Medical physics. Medical radiology. Nuclear medicine R895-920 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/893d1d07fa6a4527a329dc4580851cb1
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spelling	oai:doaj.org-article:893d1d07fa6a4527a329dc4580851cb12021-11-20T05:07:49ZProton Image-guided Radiation Assignment for Therapeutic Escalation via Selection of locally advanced head and neck cancer patients [PIRATES]: A Phase I safety and feasibility trial of MRI-guided adaptive particle radiotherapy2405-630810.1016/j.ctro.2021.11.003https://doaj.org/article/893d1d07fa6a4527a329dc4580851cb12022-01-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S240563082100094Xhttps://doaj.org/toc/2405-6308Introduction: Radiation dose-escalation for head and neck cancer (HNC) patients aiming to improve cure rates is challenging due to the increased risk of unacceptable treatment-induced toxicities. With “Proton Image-guided Radiation Assignment for Therapeutic Escalation via Selection of locally advanced head and neck cancer patients” (PIRATES), we present a novel treatment approach that is designed to facilitate dose-escalation while minimizing the risk of dose-limiting toxicities for locally advanced HPV-negative HNC patients. The aim of this Phase I trial is to assess the safety & feasibility of PIRATES approach. Methods: The PIRATES protocol employs a multi-faceted dose-escalation approach to minimize the risk of dose-limiting toxicities (DLTs): 1) sparing surrounding normal tissue from extraneous dose with intensity-modulated proton therapy, 2) mid-treatment hybrid hyper-fractionation for radiobiologic normal tissue sparing; 3) Magnetic Resonance Imaging (MRI) guided mid-treatment boost volume adaptation, and 4) iso-effective restricted organ-at-risk dosing to mucosa and bone tissues.The time-to-event Bayesian optimal interval (TITE-BOIN) design is employed to address the challenge of the long DLT window of 6 months and find the maximum tolerated dose. The primary endpoint is unacceptable radiation-induced toxicities (Grade 4, mucositis, dermatitis, or Grade 3 myelopathy, osteoradionecrosis) occurring within 6 months following radiotherapy. The second endpoint is any grade 3 toxicity occurring in 3–6 months after radiation. Discussion: The PIRATES dose-escalation approach is designed to provide a safe avenue to intensify local treatment for HNC patients for whom therapy with conventional radiation dose levels is likely to fail. PIRATES aims to minimize the radiation damage to the tissue surrounding the tumor volume with the combination of proton therapy and adaptive radiotherapy and within the high dose tumor volume with hybrid hyper-fractionation and not boosting mucosal and bone tissues. Ultimately, if successful, PIRATES has the potential to safety increase local control rates in HNC patients with high loco-regional failure risk.Trial registration: ClinicalTrials.gov ID: NCT04870840; Registration date: May 4, 2021.Netherlands Trial Register ID: NL9603; Registration date: July 15, 2021.Lisanne V. van DijkSteven J. FrankYing YuanBrandon GunnAmy C. MorenoAbdallah S.R. MohamedKathryn E. PrestonYun QingMichael T. SpiottoWilliam H. MorrisonAnna LeeJack PhanAdam S. GardenDavid I. RosenthalJohannes A. LangendijkClifton D. FullerElsevierarticleHead and neck cancerRadiation dose-escalationProton therapyImage guided RTHyper-fractionationPhase I trialMedical physics. Medical radiology. Nuclear medicineR895-920Neoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENClinical and Translational Radiation Oncology, Vol 32, Iss , Pp 35-40 (2022)
institution	DOAJ
collection	DOAJ
language	EN
topic	Head and neck cancer Radiation dose-escalation Proton therapy Image guided RT Hyper-fractionation Phase I trial Medical physics. Medical radiology. Nuclear medicine R895-920 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	Head and neck cancer Radiation dose-escalation Proton therapy Image guided RT Hyper-fractionation Phase I trial Medical physics. Medical radiology. Nuclear medicine R895-920 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Lisanne V. van Dijk Steven J. Frank Ying Yuan Brandon Gunn Amy C. Moreno Abdallah S.R. Mohamed Kathryn E. Preston Yun Qing Michael T. Spiotto William H. Morrison Anna Lee Jack Phan Adam S. Garden David I. Rosenthal Johannes A. Langendijk Clifton D. Fuller Proton Image-guided Radiation Assignment for Therapeutic Escalation via Selection of locally advanced head and neck cancer patients [PIRATES]: A Phase I safety and feasibility trial of MRI-guided adaptive particle radiotherapy
description	Introduction: Radiation dose-escalation for head and neck cancer (HNC) patients aiming to improve cure rates is challenging due to the increased risk of unacceptable treatment-induced toxicities. With “Proton Image-guided Radiation Assignment for Therapeutic Escalation via Selection of locally advanced head and neck cancer patients” (PIRATES), we present a novel treatment approach that is designed to facilitate dose-escalation while minimizing the risk of dose-limiting toxicities for locally advanced HPV-negative HNC patients. The aim of this Phase I trial is to assess the safety & feasibility of PIRATES approach. Methods: The PIRATES protocol employs a multi-faceted dose-escalation approach to minimize the risk of dose-limiting toxicities (DLTs): 1) sparing surrounding normal tissue from extraneous dose with intensity-modulated proton therapy, 2) mid-treatment hybrid hyper-fractionation for radiobiologic normal tissue sparing; 3) Magnetic Resonance Imaging (MRI) guided mid-treatment boost volume adaptation, and 4) iso-effective restricted organ-at-risk dosing to mucosa and bone tissues.The time-to-event Bayesian optimal interval (TITE-BOIN) design is employed to address the challenge of the long DLT window of 6 months and find the maximum tolerated dose. The primary endpoint is unacceptable radiation-induced toxicities (Grade 4, mucositis, dermatitis, or Grade 3 myelopathy, osteoradionecrosis) occurring within 6 months following radiotherapy. The second endpoint is any grade 3 toxicity occurring in 3–6 months after radiation. Discussion: The PIRATES dose-escalation approach is designed to provide a safe avenue to intensify local treatment for HNC patients for whom therapy with conventional radiation dose levels is likely to fail. PIRATES aims to minimize the radiation damage to the tissue surrounding the tumor volume with the combination of proton therapy and adaptive radiotherapy and within the high dose tumor volume with hybrid hyper-fractionation and not boosting mucosal and bone tissues. Ultimately, if successful, PIRATES has the potential to safety increase local control rates in HNC patients with high loco-regional failure risk.Trial registration: ClinicalTrials.gov ID: NCT04870840; Registration date: May 4, 2021.Netherlands Trial Register ID: NL9603; Registration date: July 15, 2021.
format	article
author	Lisanne V. van Dijk Steven J. Frank Ying Yuan Brandon Gunn Amy C. Moreno Abdallah S.R. Mohamed Kathryn E. Preston Yun Qing Michael T. Spiotto William H. Morrison Anna Lee Jack Phan Adam S. Garden David I. Rosenthal Johannes A. Langendijk Clifton D. Fuller
author_facet	Lisanne V. van Dijk Steven J. Frank Ying Yuan Brandon Gunn Amy C. Moreno Abdallah S.R. Mohamed Kathryn E. Preston Yun Qing Michael T. Spiotto William H. Morrison Anna Lee Jack Phan Adam S. Garden David I. Rosenthal Johannes A. Langendijk Clifton D. Fuller
author_sort	Lisanne V. van Dijk
title	Proton Image-guided Radiation Assignment for Therapeutic Escalation via Selection of locally advanced head and neck cancer patients [PIRATES]: A Phase I safety and feasibility trial of MRI-guided adaptive particle radiotherapy
title_short	Proton Image-guided Radiation Assignment for Therapeutic Escalation via Selection of locally advanced head and neck cancer patients [PIRATES]: A Phase I safety and feasibility trial of MRI-guided adaptive particle radiotherapy
title_full	Proton Image-guided Radiation Assignment for Therapeutic Escalation via Selection of locally advanced head and neck cancer patients [PIRATES]: A Phase I safety and feasibility trial of MRI-guided adaptive particle radiotherapy
title_fullStr	Proton Image-guided Radiation Assignment for Therapeutic Escalation via Selection of locally advanced head and neck cancer patients [PIRATES]: A Phase I safety and feasibility trial of MRI-guided adaptive particle radiotherapy
title_full_unstemmed	Proton Image-guided Radiation Assignment for Therapeutic Escalation via Selection of locally advanced head and neck cancer patients [PIRATES]: A Phase I safety and feasibility trial of MRI-guided adaptive particle radiotherapy
title_sort	proton image-guided radiation assignment for therapeutic escalation via selection of locally advanced head and neck cancer patients [pirates]: a phase i safety and feasibility trial of mri-guided adaptive particle radiotherapy
publisher	Elsevier
publishDate	2022
url	https://doaj.org/article/893d1d07fa6a4527a329dc4580851cb1
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Proton Image-guided Radiation Assignment for Therapeutic Escalation via Selection of locally advanced head and neck cancer patients [PIRATES]: A Phase I safety and feasibility trial of MRI-guided adaptive particle radiotherapy

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