Protocol of a phase II study to evaluate the efficacy and safety of deep-inspiration breath-hold daily online adaptive radiotherapy for centrally located lung tumours (PUDDING study)

Background Centrally located lung tumours present a challenge because of their tendency to exhibit symptoms such as airway obstruction, atelectasis, and bleeding. Surgical resection of these tumours often requires sacrificing the lungs, making definitive radiotherapy the preferred alternative to avoid pneumonectomy. However, the proximity of these tumours to mediastinal organs at risk increases the potential for severe adverse events. To mitigate this risk, we propose a dual-method approach: deep inspiration breath-hold (DIBH) radiotherapy combined with adaptive radiotherapy. The aim of this single-centre, single-arm phase II study is to investigate the efficacy and safety of DIBH daily online adaptive radiotherapy. Methods Patients diagnosed with centrally located lung tumours according to the International Association for the Study of Lung Cancer recommendations, are enrolled and subjected to DIBH daily online adaptive radiotherapy. The primary endpoint is the one-year cumulative incidence of grade 3 or more severe adverse events, as classified by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Discussion Delivering definitive radiotherapy for centrally located lung tumours presents a dilemma between ensuring optimal dose coverage for the planning target volume and the associated increased risk of adverse events. DIBH provides measurable dosimetric benefits by increasing the normal lung volume and distancing the tumour from critical mediastinal organs at risk, leading to reduced toxicity. DIBH adaptive radiotherapy has been proposed as an adjunct treatment option for abdominal and pelvic cancers. If the application of DIBH adaptive radiotherapy to centrally located lung tumours proves successful, this approach could shape future phase III trials and offer novel perspectives in lung tumour radiotherapy. Trial registration. Registered at the Japan Registry of Clinical Trials (jRCT; https://jrct.niph.go.jp/); registration number: jRCT1052230085 (https://jrct.niph.go.jp/en-latest-detail/jRCT1052230085). Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Kishi, Noriko [verfasserIn] Yoneyama, Masahiro Inoo, Hiroyuki Inoue, Minoru Iramina, Hiraku Nakakura, Akiyoshi Ono, Tomohiro Hirashima, Hideaki Adachi, Takanori Matsushita, Norimasa Sasaki, Makoto Fujimoto, Takahiro Nakamura, Mitsuhiro Matsuo, Yukinori Mizowaki, Takashi

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2024

Schlagwörter:	Primary lung tumour Metastatic lung tumour Deep-inspiration breath-hold Adaptive radiotherapy

Anmerkung:	© The Author(s) 2024

Übergeordnetes Werk:	Enthalten in: Radiation oncology - London : BioMed Central, 2006, 19(2024), 1 vom: 08. März
Übergeordnetes Werk:	volume:19 ; year:2024 ; number:1 ; day:08 ; month:03

Links:	Volltext

DOI / URN:	10.1186/s13014-024-02427-4

Katalog-ID:	SPR055075045

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allfields	10.1186/s13014-024-02427-4 doi (DE-627)SPR055075045 (SPR)s13014-024-02427-4-e DE-627 ger DE-627 rakwb eng Kishi, Noriko verfasserin aut Protocol of a phase II study to evaluate the efficacy and safety of deep-inspiration breath-hold daily online adaptive radiotherapy for centrally located lung tumours (PUDDING study) 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background Centrally located lung tumours present a challenge because of their tendency to exhibit symptoms such as airway obstruction, atelectasis, and bleeding. Surgical resection of these tumours often requires sacrificing the lungs, making definitive radiotherapy the preferred alternative to avoid pneumonectomy. However, the proximity of these tumours to mediastinal organs at risk increases the potential for severe adverse events. To mitigate this risk, we propose a dual-method approach: deep inspiration breath-hold (DIBH) radiotherapy combined with adaptive radiotherapy. The aim of this single-centre, single-arm phase II study is to investigate the efficacy and safety of DIBH daily online adaptive radiotherapy. Methods Patients diagnosed with centrally located lung tumours according to the International Association for the Study of Lung Cancer recommendations, are enrolled and subjected to DIBH daily online adaptive radiotherapy. The primary endpoint is the one-year cumulative incidence of grade 3 or more severe adverse events, as classified by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Discussion Delivering definitive radiotherapy for centrally located lung tumours presents a dilemma between ensuring optimal dose coverage for the planning target volume and the associated increased risk of adverse events. DIBH provides measurable dosimetric benefits by increasing the normal lung volume and distancing the tumour from critical mediastinal organs at risk, leading to reduced toxicity. DIBH adaptive radiotherapy has been proposed as an adjunct treatment option for abdominal and pelvic cancers. If the application of DIBH adaptive radiotherapy to centrally located lung tumours proves successful, this approach could shape future phase III trials and offer novel perspectives in lung tumour radiotherapy. Trial registration. Registered at the Japan Registry of Clinical Trials (jRCT; https://jrct.niph.go.jp/); registration number: jRCT1052230085 (https://jrct.niph.go.jp/en-latest-detail/jRCT1052230085). Primary lung tumour (dpeaa)DE-He213 Metastatic lung tumour (dpeaa)DE-He213 Deep-inspiration breath-hold (dpeaa)DE-He213 Adaptive radiotherapy (dpeaa)DE-He213 Yoneyama, Masahiro aut Inoo, Hiroyuki aut Inoue, Minoru aut Iramina, Hiraku aut Nakakura, Akiyoshi aut Ono, Tomohiro aut Hirashima, Hideaki aut Adachi, Takanori aut Matsushita, Norimasa aut Sasaki, Makoto aut Fujimoto, Takahiro aut Nakamura, Mitsuhiro aut Matsuo, Yukinori aut Mizowaki, Takashi aut Enthalten in Radiation oncology London : BioMed Central, 2006 19(2024), 1 vom: 08. März (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:19 year:2024 number:1 day:08 month:03 https://dx.doi.org/10.1186/s13014-024-02427-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2119 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2024 1 08 03
spelling	10.1186/s13014-024-02427-4 doi (DE-627)SPR055075045 (SPR)s13014-024-02427-4-e DE-627 ger DE-627 rakwb eng Kishi, Noriko verfasserin aut Protocol of a phase II study to evaluate the efficacy and safety of deep-inspiration breath-hold daily online adaptive radiotherapy for centrally located lung tumours (PUDDING study) 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background Centrally located lung tumours present a challenge because of their tendency to exhibit symptoms such as airway obstruction, atelectasis, and bleeding. Surgical resection of these tumours often requires sacrificing the lungs, making definitive radiotherapy the preferred alternative to avoid pneumonectomy. However, the proximity of these tumours to mediastinal organs at risk increases the potential for severe adverse events. To mitigate this risk, we propose a dual-method approach: deep inspiration breath-hold (DIBH) radiotherapy combined with adaptive radiotherapy. The aim of this single-centre, single-arm phase II study is to investigate the efficacy and safety of DIBH daily online adaptive radiotherapy. Methods Patients diagnosed with centrally located lung tumours according to the International Association for the Study of Lung Cancer recommendations, are enrolled and subjected to DIBH daily online adaptive radiotherapy. The primary endpoint is the one-year cumulative incidence of grade 3 or more severe adverse events, as classified by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Discussion Delivering definitive radiotherapy for centrally located lung tumours presents a dilemma between ensuring optimal dose coverage for the planning target volume and the associated increased risk of adverse events. DIBH provides measurable dosimetric benefits by increasing the normal lung volume and distancing the tumour from critical mediastinal organs at risk, leading to reduced toxicity. DIBH adaptive radiotherapy has been proposed as an adjunct treatment option for abdominal and pelvic cancers. If the application of DIBH adaptive radiotherapy to centrally located lung tumours proves successful, this approach could shape future phase III trials and offer novel perspectives in lung tumour radiotherapy. Trial registration. Registered at the Japan Registry of Clinical Trials (jRCT; https://jrct.niph.go.jp/); registration number: jRCT1052230085 (https://jrct.niph.go.jp/en-latest-detail/jRCT1052230085). Primary lung tumour (dpeaa)DE-He213 Metastatic lung tumour (dpeaa)DE-He213 Deep-inspiration breath-hold (dpeaa)DE-He213 Adaptive radiotherapy (dpeaa)DE-He213 Yoneyama, Masahiro aut Inoo, Hiroyuki aut Inoue, Minoru aut Iramina, Hiraku aut Nakakura, Akiyoshi aut Ono, Tomohiro aut Hirashima, Hideaki aut Adachi, Takanori aut Matsushita, Norimasa aut Sasaki, Makoto aut Fujimoto, Takahiro aut Nakamura, Mitsuhiro aut Matsuo, Yukinori aut Mizowaki, Takashi aut Enthalten in Radiation oncology London : BioMed Central, 2006 19(2024), 1 vom: 08. März (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:19 year:2024 number:1 day:08 month:03 https://dx.doi.org/10.1186/s13014-024-02427-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2119 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2024 1 08 03
allfields_unstemmed	10.1186/s13014-024-02427-4 doi (DE-627)SPR055075045 (SPR)s13014-024-02427-4-e DE-627 ger DE-627 rakwb eng Kishi, Noriko verfasserin aut Protocol of a phase II study to evaluate the efficacy and safety of deep-inspiration breath-hold daily online adaptive radiotherapy for centrally located lung tumours (PUDDING study) 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background Centrally located lung tumours present a challenge because of their tendency to exhibit symptoms such as airway obstruction, atelectasis, and bleeding. Surgical resection of these tumours often requires sacrificing the lungs, making definitive radiotherapy the preferred alternative to avoid pneumonectomy. However, the proximity of these tumours to mediastinal organs at risk increases the potential for severe adverse events. To mitigate this risk, we propose a dual-method approach: deep inspiration breath-hold (DIBH) radiotherapy combined with adaptive radiotherapy. The aim of this single-centre, single-arm phase II study is to investigate the efficacy and safety of DIBH daily online adaptive radiotherapy. Methods Patients diagnosed with centrally located lung tumours according to the International Association for the Study of Lung Cancer recommendations, are enrolled and subjected to DIBH daily online adaptive radiotherapy. The primary endpoint is the one-year cumulative incidence of grade 3 or more severe adverse events, as classified by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Discussion Delivering definitive radiotherapy for centrally located lung tumours presents a dilemma between ensuring optimal dose coverage for the planning target volume and the associated increased risk of adverse events. DIBH provides measurable dosimetric benefits by increasing the normal lung volume and distancing the tumour from critical mediastinal organs at risk, leading to reduced toxicity. DIBH adaptive radiotherapy has been proposed as an adjunct treatment option for abdominal and pelvic cancers. If the application of DIBH adaptive radiotherapy to centrally located lung tumours proves successful, this approach could shape future phase III trials and offer novel perspectives in lung tumour radiotherapy. Trial registration. Registered at the Japan Registry of Clinical Trials (jRCT; https://jrct.niph.go.jp/); registration number: jRCT1052230085 (https://jrct.niph.go.jp/en-latest-detail/jRCT1052230085). Primary lung tumour (dpeaa)DE-He213 Metastatic lung tumour (dpeaa)DE-He213 Deep-inspiration breath-hold (dpeaa)DE-He213 Adaptive radiotherapy (dpeaa)DE-He213 Yoneyama, Masahiro aut Inoo, Hiroyuki aut Inoue, Minoru aut Iramina, Hiraku aut Nakakura, Akiyoshi aut Ono, Tomohiro aut Hirashima, Hideaki aut Adachi, Takanori aut Matsushita, Norimasa aut Sasaki, Makoto aut Fujimoto, Takahiro aut Nakamura, Mitsuhiro aut Matsuo, Yukinori aut Mizowaki, Takashi aut Enthalten in Radiation oncology London : BioMed Central, 2006 19(2024), 1 vom: 08. März (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:19 year:2024 number:1 day:08 month:03 https://dx.doi.org/10.1186/s13014-024-02427-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2119 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2024 1 08 03
allfieldsGer	10.1186/s13014-024-02427-4 doi (DE-627)SPR055075045 (SPR)s13014-024-02427-4-e DE-627 ger DE-627 rakwb eng Kishi, Noriko verfasserin aut Protocol of a phase II study to evaluate the efficacy and safety of deep-inspiration breath-hold daily online adaptive radiotherapy for centrally located lung tumours (PUDDING study) 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background Centrally located lung tumours present a challenge because of their tendency to exhibit symptoms such as airway obstruction, atelectasis, and bleeding. Surgical resection of these tumours often requires sacrificing the lungs, making definitive radiotherapy the preferred alternative to avoid pneumonectomy. However, the proximity of these tumours to mediastinal organs at risk increases the potential for severe adverse events. To mitigate this risk, we propose a dual-method approach: deep inspiration breath-hold (DIBH) radiotherapy combined with adaptive radiotherapy. The aim of this single-centre, single-arm phase II study is to investigate the efficacy and safety of DIBH daily online adaptive radiotherapy. Methods Patients diagnosed with centrally located lung tumours according to the International Association for the Study of Lung Cancer recommendations, are enrolled and subjected to DIBH daily online adaptive radiotherapy. The primary endpoint is the one-year cumulative incidence of grade 3 or more severe adverse events, as classified by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Discussion Delivering definitive radiotherapy for centrally located lung tumours presents a dilemma between ensuring optimal dose coverage for the planning target volume and the associated increased risk of adverse events. DIBH provides measurable dosimetric benefits by increasing the normal lung volume and distancing the tumour from critical mediastinal organs at risk, leading to reduced toxicity. DIBH adaptive radiotherapy has been proposed as an adjunct treatment option for abdominal and pelvic cancers. If the application of DIBH adaptive radiotherapy to centrally located lung tumours proves successful, this approach could shape future phase III trials and offer novel perspectives in lung tumour radiotherapy. Trial registration. Registered at the Japan Registry of Clinical Trials (jRCT; https://jrct.niph.go.jp/); registration number: jRCT1052230085 (https://jrct.niph.go.jp/en-latest-detail/jRCT1052230085). Primary lung tumour (dpeaa)DE-He213 Metastatic lung tumour (dpeaa)DE-He213 Deep-inspiration breath-hold (dpeaa)DE-He213 Adaptive radiotherapy (dpeaa)DE-He213 Yoneyama, Masahiro aut Inoo, Hiroyuki aut Inoue, Minoru aut Iramina, Hiraku aut Nakakura, Akiyoshi aut Ono, Tomohiro aut Hirashima, Hideaki aut Adachi, Takanori aut Matsushita, Norimasa aut Sasaki, Makoto aut Fujimoto, Takahiro aut Nakamura, Mitsuhiro aut Matsuo, Yukinori aut Mizowaki, Takashi aut Enthalten in Radiation oncology London : BioMed Central, 2006 19(2024), 1 vom: 08. März (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:19 year:2024 number:1 day:08 month:03 https://dx.doi.org/10.1186/s13014-024-02427-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2119 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2024 1 08 03
allfieldsSound	10.1186/s13014-024-02427-4 doi (DE-627)SPR055075045 (SPR)s13014-024-02427-4-e DE-627 ger DE-627 rakwb eng Kishi, Noriko verfasserin aut Protocol of a phase II study to evaluate the efficacy and safety of deep-inspiration breath-hold daily online adaptive radiotherapy for centrally located lung tumours (PUDDING study) 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background Centrally located lung tumours present a challenge because of their tendency to exhibit symptoms such as airway obstruction, atelectasis, and bleeding. Surgical resection of these tumours often requires sacrificing the lungs, making definitive radiotherapy the preferred alternative to avoid pneumonectomy. However, the proximity of these tumours to mediastinal organs at risk increases the potential for severe adverse events. To mitigate this risk, we propose a dual-method approach: deep inspiration breath-hold (DIBH) radiotherapy combined with adaptive radiotherapy. The aim of this single-centre, single-arm phase II study is to investigate the efficacy and safety of DIBH daily online adaptive radiotherapy. Methods Patients diagnosed with centrally located lung tumours according to the International Association for the Study of Lung Cancer recommendations, are enrolled and subjected to DIBH daily online adaptive radiotherapy. The primary endpoint is the one-year cumulative incidence of grade 3 or more severe adverse events, as classified by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Discussion Delivering definitive radiotherapy for centrally located lung tumours presents a dilemma between ensuring optimal dose coverage for the planning target volume and the associated increased risk of adverse events. DIBH provides measurable dosimetric benefits by increasing the normal lung volume and distancing the tumour from critical mediastinal organs at risk, leading to reduced toxicity. DIBH adaptive radiotherapy has been proposed as an adjunct treatment option for abdominal and pelvic cancers. If the application of DIBH adaptive radiotherapy to centrally located lung tumours proves successful, this approach could shape future phase III trials and offer novel perspectives in lung tumour radiotherapy. Trial registration. Registered at the Japan Registry of Clinical Trials (jRCT; https://jrct.niph.go.jp/); registration number: jRCT1052230085 (https://jrct.niph.go.jp/en-latest-detail/jRCT1052230085). Primary lung tumour (dpeaa)DE-He213 Metastatic lung tumour (dpeaa)DE-He213 Deep-inspiration breath-hold (dpeaa)DE-He213 Adaptive radiotherapy (dpeaa)DE-He213 Yoneyama, Masahiro aut Inoo, Hiroyuki aut Inoue, Minoru aut Iramina, Hiraku aut Nakakura, Akiyoshi aut Ono, Tomohiro aut Hirashima, Hideaki aut Adachi, Takanori aut Matsushita, Norimasa aut Sasaki, Makoto aut Fujimoto, Takahiro aut Nakamura, Mitsuhiro aut Matsuo, Yukinori aut Mizowaki, Takashi aut Enthalten in Radiation oncology London : BioMed Central, 2006 19(2024), 1 vom: 08. März (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:19 year:2024 number:1 day:08 month:03 https://dx.doi.org/10.1186/s13014-024-02427-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2119 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2024 1 08 03
language	English
source	Enthalten in Radiation oncology 19(2024), 1 vom: 08. März volume:19 year:2024 number:1 day:08 month:03
sourceStr	Enthalten in Radiation oncology 19(2024), 1 vom: 08. März volume:19 year:2024 number:1 day:08 month:03
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Primary lung tumour Metastatic lung tumour Deep-inspiration breath-hold Adaptive radiotherapy
isfreeaccess_bool	true
container_title	Radiation oncology
authorswithroles_txt_mv	Kishi, Noriko @@aut@@ Yoneyama, Masahiro @@aut@@ Inoo, Hiroyuki @@aut@@ Inoue, Minoru @@aut@@ Iramina, Hiraku @@aut@@ Nakakura, Akiyoshi @@aut@@ Ono, Tomohiro @@aut@@ Hirashima, Hideaki @@aut@@ Adachi, Takanori @@aut@@ Matsushita, Norimasa @@aut@@ Sasaki, Makoto @@aut@@ Fujimoto, Takahiro @@aut@@ Nakamura, Mitsuhiro @@aut@@ Matsuo, Yukinori @@aut@@ Mizowaki, Takashi @@aut@@
publishDateDaySort_date	2024-03-08T00:00:00Z
hierarchy_top_id	508725739
id	SPR055075045
language_de	englisch
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author	Kishi, Noriko
spellingShingle	Kishi, Noriko misc Primary lung tumour misc Metastatic lung tumour misc Deep-inspiration breath-hold misc Adaptive radiotherapy Protocol of a phase II study to evaluate the efficacy and safety of deep-inspiration breath-hold daily online adaptive radiotherapy for centrally located lung tumours (PUDDING study)
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topic_title	Protocol of a phase II study to evaluate the efficacy and safety of deep-inspiration breath-hold daily online adaptive radiotherapy for centrally located lung tumours (PUDDING study) Primary lung tumour (dpeaa)DE-He213 Metastatic lung tumour (dpeaa)DE-He213 Deep-inspiration breath-hold (dpeaa)DE-He213 Adaptive radiotherapy (dpeaa)DE-He213
topic	misc Primary lung tumour misc Metastatic lung tumour misc Deep-inspiration breath-hold misc Adaptive radiotherapy
topic_unstemmed	misc Primary lung tumour misc Metastatic lung tumour misc Deep-inspiration breath-hold misc Adaptive radiotherapy
topic_browse	misc Primary lung tumour misc Metastatic lung tumour misc Deep-inspiration breath-hold misc Adaptive radiotherapy
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title	Protocol of a phase II study to evaluate the efficacy and safety of deep-inspiration breath-hold daily online adaptive radiotherapy for centrally located lung tumours (PUDDING study)
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title_full	Protocol of a phase II study to evaluate the efficacy and safety of deep-inspiration breath-hold daily online adaptive radiotherapy for centrally located lung tumours (PUDDING study)
author_sort	Kishi, Noriko
journal	Radiation oncology
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author_browse	Kishi, Noriko Yoneyama, Masahiro Inoo, Hiroyuki Inoue, Minoru Iramina, Hiraku Nakakura, Akiyoshi Ono, Tomohiro Hirashima, Hideaki Adachi, Takanori Matsushita, Norimasa Sasaki, Makoto Fujimoto, Takahiro Nakamura, Mitsuhiro Matsuo, Yukinori Mizowaki, Takashi
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doi_str_mv	10.1186/s13014-024-02427-4
title_sort	protocol of a phase ii study to evaluate the efficacy and safety of deep-inspiration breath-hold daily online adaptive radiotherapy for centrally located lung tumours (pudding study)
title_auth	Protocol of a phase II study to evaluate the efficacy and safety of deep-inspiration breath-hold daily online adaptive radiotherapy for centrally located lung tumours (PUDDING study)
abstract	Background Centrally located lung tumours present a challenge because of their tendency to exhibit symptoms such as airway obstruction, atelectasis, and bleeding. Surgical resection of these tumours often requires sacrificing the lungs, making definitive radiotherapy the preferred alternative to avoid pneumonectomy. However, the proximity of these tumours to mediastinal organs at risk increases the potential for severe adverse events. To mitigate this risk, we propose a dual-method approach: deep inspiration breath-hold (DIBH) radiotherapy combined with adaptive radiotherapy. The aim of this single-centre, single-arm phase II study is to investigate the efficacy and safety of DIBH daily online adaptive radiotherapy. Methods Patients diagnosed with centrally located lung tumours according to the International Association for the Study of Lung Cancer recommendations, are enrolled and subjected to DIBH daily online adaptive radiotherapy. The primary endpoint is the one-year cumulative incidence of grade 3 or more severe adverse events, as classified by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Discussion Delivering definitive radiotherapy for centrally located lung tumours presents a dilemma between ensuring optimal dose coverage for the planning target volume and the associated increased risk of adverse events. DIBH provides measurable dosimetric benefits by increasing the normal lung volume and distancing the tumour from critical mediastinal organs at risk, leading to reduced toxicity. DIBH adaptive radiotherapy has been proposed as an adjunct treatment option for abdominal and pelvic cancers. If the application of DIBH adaptive radiotherapy to centrally located lung tumours proves successful, this approach could shape future phase III trials and offer novel perspectives in lung tumour radiotherapy. Trial registration. Registered at the Japan Registry of Clinical Trials (jRCT; https://jrct.niph.go.jp/); registration number: jRCT1052230085 (https://jrct.niph.go.jp/en-latest-detail/jRCT1052230085). © The Author(s) 2024
abstractGer	Background Centrally located lung tumours present a challenge because of their tendency to exhibit symptoms such as airway obstruction, atelectasis, and bleeding. Surgical resection of these tumours often requires sacrificing the lungs, making definitive radiotherapy the preferred alternative to avoid pneumonectomy. However, the proximity of these tumours to mediastinal organs at risk increases the potential for severe adverse events. To mitigate this risk, we propose a dual-method approach: deep inspiration breath-hold (DIBH) radiotherapy combined with adaptive radiotherapy. The aim of this single-centre, single-arm phase II study is to investigate the efficacy and safety of DIBH daily online adaptive radiotherapy. Methods Patients diagnosed with centrally located lung tumours according to the International Association for the Study of Lung Cancer recommendations, are enrolled and subjected to DIBH daily online adaptive radiotherapy. The primary endpoint is the one-year cumulative incidence of grade 3 or more severe adverse events, as classified by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Discussion Delivering definitive radiotherapy for centrally located lung tumours presents a dilemma between ensuring optimal dose coverage for the planning target volume and the associated increased risk of adverse events. DIBH provides measurable dosimetric benefits by increasing the normal lung volume and distancing the tumour from critical mediastinal organs at risk, leading to reduced toxicity. DIBH adaptive radiotherapy has been proposed as an adjunct treatment option for abdominal and pelvic cancers. If the application of DIBH adaptive radiotherapy to centrally located lung tumours proves successful, this approach could shape future phase III trials and offer novel perspectives in lung tumour radiotherapy. Trial registration. Registered at the Japan Registry of Clinical Trials (jRCT; https://jrct.niph.go.jp/); registration number: jRCT1052230085 (https://jrct.niph.go.jp/en-latest-detail/jRCT1052230085). © The Author(s) 2024
abstract_unstemmed	Background Centrally located lung tumours present a challenge because of their tendency to exhibit symptoms such as airway obstruction, atelectasis, and bleeding. Surgical resection of these tumours often requires sacrificing the lungs, making definitive radiotherapy the preferred alternative to avoid pneumonectomy. However, the proximity of these tumours to mediastinal organs at risk increases the potential for severe adverse events. To mitigate this risk, we propose a dual-method approach: deep inspiration breath-hold (DIBH) radiotherapy combined with adaptive radiotherapy. The aim of this single-centre, single-arm phase II study is to investigate the efficacy and safety of DIBH daily online adaptive radiotherapy. Methods Patients diagnosed with centrally located lung tumours according to the International Association for the Study of Lung Cancer recommendations, are enrolled and subjected to DIBH daily online adaptive radiotherapy. The primary endpoint is the one-year cumulative incidence of grade 3 or more severe adverse events, as classified by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Discussion Delivering definitive radiotherapy for centrally located lung tumours presents a dilemma between ensuring optimal dose coverage for the planning target volume and the associated increased risk of adverse events. DIBH provides measurable dosimetric benefits by increasing the normal lung volume and distancing the tumour from critical mediastinal organs at risk, leading to reduced toxicity. DIBH adaptive radiotherapy has been proposed as an adjunct treatment option for abdominal and pelvic cancers. If the application of DIBH adaptive radiotherapy to centrally located lung tumours proves successful, this approach could shape future phase III trials and offer novel perspectives in lung tumour radiotherapy. Trial registration. Registered at the Japan Registry of Clinical Trials (jRCT; https://jrct.niph.go.jp/); registration number: jRCT1052230085 (https://jrct.niph.go.jp/en-latest-detail/jRCT1052230085). © The Author(s) 2024
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title_short	Protocol of a phase II study to evaluate the efficacy and safety of deep-inspiration breath-hold daily online adaptive radiotherapy for centrally located lung tumours (PUDDING study)
url	https://dx.doi.org/10.1186/s13014-024-02427-4
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author2	Yoneyama, Masahiro Inoo, Hiroyuki Inoue, Minoru Iramina, Hiraku Nakakura, Akiyoshi Ono, Tomohiro Hirashima, Hideaki Adachi, Takanori Matsushita, Norimasa Sasaki, Makoto Fujimoto, Takahiro Nakamura, Mitsuhiro Matsuo, Yukinori Mizowaki, Takashi
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Protocol of a phase II study to evaluate the efficacy and safety of deep-inspiration breath-hold daily online adaptive radiotherapy for centrally located lung tumours (PUDDING study)

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