Pulmonary magnetic resonance-guided online adaptive radiotherapy of locally advanced non-small-cell lung cancer: the PUMA trial
Background Patients with locally-advanced non-small-cell lung cancer (LA-NSCLC) are often ineligible for surgery, so that definitive chemoradiotherapy (CRT) represents the treatment of choice. Nevertheless, long-term tumor control is often not achieved. Intensification of radiotherapy (RT) to improv...
Ausführliche Beschreibung
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Regnery, Sebastian [verfasserIn] |
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Englisch |
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2023 |
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© The Author(s) 2023. corrected publication 2023 |
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Übergeordnetes Werk: |
Enthalten in: Radiation oncology - London : BioMed Central, 2006, 18(2023), 1 vom: 04. Mai |
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Übergeordnetes Werk: |
volume:18 ; year:2023 ; number:1 ; day:04 ; month:05 |
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DOI / URN: |
10.1186/s13014-023-02258-9 |
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SPR050298348 |
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520 | |a Background Patients with locally-advanced non-small-cell lung cancer (LA-NSCLC) are often ineligible for surgery, so that definitive chemoradiotherapy (CRT) represents the treatment of choice. Nevertheless, long-term tumor control is often not achieved. Intensification of radiotherapy (RT) to improve locoregional tumor control is limited by the detrimental effect of higher radiation exposure of thoracic organs-at-risk (OAR). This narrow therapeutic ratio may be expanded by exploiting the advantages of magnetic resonance (MR) linear accelerators, mainly the online adaptation of the treatment plan to the current anatomy based on daily acquired MR images. However, MR-guidance is both labor-intensive and increases treatment times, which raises the question of its clinical feasibility to treat LA-NSCLC. Therefore, the PUMA trial was designed as a prospective, multicenter phase I trial to demonstrate the clinical feasibility of MR-guided online adaptive RT in LA-NSCLC. Methods Thirty patients with LA-NSCLC in stage III A-C will be accrued at three German university hospitals to receive MR-guided online adaptive RT at two different MR-linac systems (MRIdian Linac®, View Ray Inc. and Elekta Unity®, Elekta AB) with concurrent chemotherapy. Conventionally fractioned RT with isotoxic dose escalation up to 70 Gy is applied. Online plan adaptation is performed once weekly or in case of major anatomical changes. Patients are followed-up by thoracic CT- and MR-imaging for 24 months after treatment. The primary endpoint is twofold: (1) successfully completed online adapted fractions, (2) on-table time. Main secondary endpoints include adaptation frequency, toxicity, local tumor control, progression-free and overall survival. Discussion PUMA aims to demonstrate the clinical feasibility of MR-guided online adaptive RT of LA-NSCLC. If successful, PUMA will be followed by a clinical phase II trial that further investigates the clinical benefits of this approach. Moreover, PUMA is part of a large multidisciplinary project to develop MR-guidance techniques. Trial registration ClinicalTrials.gov: NCT05237453. | ||
650 | 4 | |a Non-small-cell lung carcinoma |7 (dpeaa)DE-He213 | |
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700 | 1 | |a de Colle, Chiara |4 aut | |
700 | 1 | |a Eze, Chukwuka |4 aut | |
700 | 1 | |a Corradini, Stefanie |4 aut | |
700 | 1 | |a Thieke, Christian |4 aut | |
700 | 1 | |a Sedlaczek, Oliver |4 aut | |
700 | 1 | |a Schlemmer, Heinz-Peter |4 aut | |
700 | 1 | |a Dinkel, Julien |4 aut | |
700 | 1 | |a Seith, Ferdinand |4 aut | |
700 | 1 | |a Kopp-Schneider, Annette |4 aut | |
700 | 1 | |a Gillmann, Clarissa |4 aut | |
700 | 1 | |a Renkamp, C. Katharina |4 aut | |
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700 | 1 | |a Thorwarth, Daniela |4 aut | |
700 | 1 | |a Zips, Daniel |4 aut | |
700 | 1 | |a Belka, Claus |4 aut | |
700 | 1 | |a Jäkel, Oliver |4 aut | |
700 | 1 | |a Debus, Jürgen |4 aut | |
700 | 1 | |a Hörner-Rieber, Juliane |4 aut | |
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10.1186/s13014-023-02258-9 doi (DE-627)SPR050298348 (SPR)s13014-023-02258-9-e DE-627 ger DE-627 rakwb eng Regnery, Sebastian verfasserin aut Pulmonary magnetic resonance-guided online adaptive radiotherapy of locally advanced non-small-cell lung cancer: the PUMA trial 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023. corrected publication 2023 Background Patients with locally-advanced non-small-cell lung cancer (LA-NSCLC) are often ineligible for surgery, so that definitive chemoradiotherapy (CRT) represents the treatment of choice. Nevertheless, long-term tumor control is often not achieved. Intensification of radiotherapy (RT) to improve locoregional tumor control is limited by the detrimental effect of higher radiation exposure of thoracic organs-at-risk (OAR). This narrow therapeutic ratio may be expanded by exploiting the advantages of magnetic resonance (MR) linear accelerators, mainly the online adaptation of the treatment plan to the current anatomy based on daily acquired MR images. However, MR-guidance is both labor-intensive and increases treatment times, which raises the question of its clinical feasibility to treat LA-NSCLC. Therefore, the PUMA trial was designed as a prospective, multicenter phase I trial to demonstrate the clinical feasibility of MR-guided online adaptive RT in LA-NSCLC. Methods Thirty patients with LA-NSCLC in stage III A-C will be accrued at three German university hospitals to receive MR-guided online adaptive RT at two different MR-linac systems (MRIdian Linac®, View Ray Inc. and Elekta Unity®, Elekta AB) with concurrent chemotherapy. Conventionally fractioned RT with isotoxic dose escalation up to 70 Gy is applied. Online plan adaptation is performed once weekly or in case of major anatomical changes. Patients are followed-up by thoracic CT- and MR-imaging for 24 months after treatment. The primary endpoint is twofold: (1) successfully completed online adapted fractions, (2) on-table time. Main secondary endpoints include adaptation frequency, toxicity, local tumor control, progression-free and overall survival. Discussion PUMA aims to demonstrate the clinical feasibility of MR-guided online adaptive RT of LA-NSCLC. If successful, PUMA will be followed by a clinical phase II trial that further investigates the clinical benefits of this approach. Moreover, PUMA is part of a large multidisciplinary project to develop MR-guidance techniques. Trial registration ClinicalTrials.gov: NCT05237453. Non-small-cell lung carcinoma (dpeaa)DE-He213 Lung Cancer (dpeaa)DE-He213 Image-guided Radiotherapy (dpeaa)DE-He213 MRI (dpeaa)DE-He213 MR-guided Radiotherapy (dpeaa)DE-He213 Adaptation (dpeaa)DE-He213 Gating (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 de Colle, Chiara aut Eze, Chukwuka aut Corradini, Stefanie aut Thieke, Christian aut Sedlaczek, Oliver aut Schlemmer, Heinz-Peter aut Dinkel, Julien aut Seith, Ferdinand aut Kopp-Schneider, Annette aut Gillmann, Clarissa aut Renkamp, C. Katharina aut Landry, Guillaume aut Thorwarth, Daniela aut Zips, Daniel aut Belka, Claus aut Jäkel, Oliver aut Debus, Jürgen aut Hörner-Rieber, Juliane aut Enthalten in Radiation oncology London : BioMed Central, 2006 18(2023), 1 vom: 04. Mai (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:18 year:2023 number:1 day:04 month:05 https://dx.doi.org/10.1186/s13014-023-02258-9 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 18 2023 1 04 05 |
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10.1186/s13014-023-02258-9 doi (DE-627)SPR050298348 (SPR)s13014-023-02258-9-e DE-627 ger DE-627 rakwb eng Regnery, Sebastian verfasserin aut Pulmonary magnetic resonance-guided online adaptive radiotherapy of locally advanced non-small-cell lung cancer: the PUMA trial 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023. corrected publication 2023 Background Patients with locally-advanced non-small-cell lung cancer (LA-NSCLC) are often ineligible for surgery, so that definitive chemoradiotherapy (CRT) represents the treatment of choice. Nevertheless, long-term tumor control is often not achieved. Intensification of radiotherapy (RT) to improve locoregional tumor control is limited by the detrimental effect of higher radiation exposure of thoracic organs-at-risk (OAR). This narrow therapeutic ratio may be expanded by exploiting the advantages of magnetic resonance (MR) linear accelerators, mainly the online adaptation of the treatment plan to the current anatomy based on daily acquired MR images. However, MR-guidance is both labor-intensive and increases treatment times, which raises the question of its clinical feasibility to treat LA-NSCLC. Therefore, the PUMA trial was designed as a prospective, multicenter phase I trial to demonstrate the clinical feasibility of MR-guided online adaptive RT in LA-NSCLC. Methods Thirty patients with LA-NSCLC in stage III A-C will be accrued at three German university hospitals to receive MR-guided online adaptive RT at two different MR-linac systems (MRIdian Linac®, View Ray Inc. and Elekta Unity®, Elekta AB) with concurrent chemotherapy. Conventionally fractioned RT with isotoxic dose escalation up to 70 Gy is applied. Online plan adaptation is performed once weekly or in case of major anatomical changes. Patients are followed-up by thoracic CT- and MR-imaging for 24 months after treatment. The primary endpoint is twofold: (1) successfully completed online adapted fractions, (2) on-table time. Main secondary endpoints include adaptation frequency, toxicity, local tumor control, progression-free and overall survival. Discussion PUMA aims to demonstrate the clinical feasibility of MR-guided online adaptive RT of LA-NSCLC. If successful, PUMA will be followed by a clinical phase II trial that further investigates the clinical benefits of this approach. Moreover, PUMA is part of a large multidisciplinary project to develop MR-guidance techniques. Trial registration ClinicalTrials.gov: NCT05237453. Non-small-cell lung carcinoma (dpeaa)DE-He213 Lung Cancer (dpeaa)DE-He213 Image-guided Radiotherapy (dpeaa)DE-He213 MRI (dpeaa)DE-He213 MR-guided Radiotherapy (dpeaa)DE-He213 Adaptation (dpeaa)DE-He213 Gating (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 de Colle, Chiara aut Eze, Chukwuka aut Corradini, Stefanie aut Thieke, Christian aut Sedlaczek, Oliver aut Schlemmer, Heinz-Peter aut Dinkel, Julien aut Seith, Ferdinand aut Kopp-Schneider, Annette aut Gillmann, Clarissa aut Renkamp, C. Katharina aut Landry, Guillaume aut Thorwarth, Daniela aut Zips, Daniel aut Belka, Claus aut Jäkel, Oliver aut Debus, Jürgen aut Hörner-Rieber, Juliane aut Enthalten in Radiation oncology London : BioMed Central, 2006 18(2023), 1 vom: 04. Mai (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:18 year:2023 number:1 day:04 month:05 https://dx.doi.org/10.1186/s13014-023-02258-9 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 18 2023 1 04 05 |
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10.1186/s13014-023-02258-9 doi (DE-627)SPR050298348 (SPR)s13014-023-02258-9-e DE-627 ger DE-627 rakwb eng Regnery, Sebastian verfasserin aut Pulmonary magnetic resonance-guided online adaptive radiotherapy of locally advanced non-small-cell lung cancer: the PUMA trial 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023. corrected publication 2023 Background Patients with locally-advanced non-small-cell lung cancer (LA-NSCLC) are often ineligible for surgery, so that definitive chemoradiotherapy (CRT) represents the treatment of choice. Nevertheless, long-term tumor control is often not achieved. Intensification of radiotherapy (RT) to improve locoregional tumor control is limited by the detrimental effect of higher radiation exposure of thoracic organs-at-risk (OAR). This narrow therapeutic ratio may be expanded by exploiting the advantages of magnetic resonance (MR) linear accelerators, mainly the online adaptation of the treatment plan to the current anatomy based on daily acquired MR images. However, MR-guidance is both labor-intensive and increases treatment times, which raises the question of its clinical feasibility to treat LA-NSCLC. Therefore, the PUMA trial was designed as a prospective, multicenter phase I trial to demonstrate the clinical feasibility of MR-guided online adaptive RT in LA-NSCLC. Methods Thirty patients with LA-NSCLC in stage III A-C will be accrued at three German university hospitals to receive MR-guided online adaptive RT at two different MR-linac systems (MRIdian Linac®, View Ray Inc. and Elekta Unity®, Elekta AB) with concurrent chemotherapy. Conventionally fractioned RT with isotoxic dose escalation up to 70 Gy is applied. Online plan adaptation is performed once weekly or in case of major anatomical changes. Patients are followed-up by thoracic CT- and MR-imaging for 24 months after treatment. The primary endpoint is twofold: (1) successfully completed online adapted fractions, (2) on-table time. Main secondary endpoints include adaptation frequency, toxicity, local tumor control, progression-free and overall survival. Discussion PUMA aims to demonstrate the clinical feasibility of MR-guided online adaptive RT of LA-NSCLC. If successful, PUMA will be followed by a clinical phase II trial that further investigates the clinical benefits of this approach. Moreover, PUMA is part of a large multidisciplinary project to develop MR-guidance techniques. Trial registration ClinicalTrials.gov: NCT05237453. Non-small-cell lung carcinoma (dpeaa)DE-He213 Lung Cancer (dpeaa)DE-He213 Image-guided Radiotherapy (dpeaa)DE-He213 MRI (dpeaa)DE-He213 MR-guided Radiotherapy (dpeaa)DE-He213 Adaptation (dpeaa)DE-He213 Gating (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 de Colle, Chiara aut Eze, Chukwuka aut Corradini, Stefanie aut Thieke, Christian aut Sedlaczek, Oliver aut Schlemmer, Heinz-Peter aut Dinkel, Julien aut Seith, Ferdinand aut Kopp-Schneider, Annette aut Gillmann, Clarissa aut Renkamp, C. Katharina aut Landry, Guillaume aut Thorwarth, Daniela aut Zips, Daniel aut Belka, Claus aut Jäkel, Oliver aut Debus, Jürgen aut Hörner-Rieber, Juliane aut Enthalten in Radiation oncology London : BioMed Central, 2006 18(2023), 1 vom: 04. Mai (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:18 year:2023 number:1 day:04 month:05 https://dx.doi.org/10.1186/s13014-023-02258-9 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 18 2023 1 04 05 |
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10.1186/s13014-023-02258-9 doi (DE-627)SPR050298348 (SPR)s13014-023-02258-9-e DE-627 ger DE-627 rakwb eng Regnery, Sebastian verfasserin aut Pulmonary magnetic resonance-guided online adaptive radiotherapy of locally advanced non-small-cell lung cancer: the PUMA trial 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023. corrected publication 2023 Background Patients with locally-advanced non-small-cell lung cancer (LA-NSCLC) are often ineligible for surgery, so that definitive chemoradiotherapy (CRT) represents the treatment of choice. Nevertheless, long-term tumor control is often not achieved. Intensification of radiotherapy (RT) to improve locoregional tumor control is limited by the detrimental effect of higher radiation exposure of thoracic organs-at-risk (OAR). This narrow therapeutic ratio may be expanded by exploiting the advantages of magnetic resonance (MR) linear accelerators, mainly the online adaptation of the treatment plan to the current anatomy based on daily acquired MR images. However, MR-guidance is both labor-intensive and increases treatment times, which raises the question of its clinical feasibility to treat LA-NSCLC. Therefore, the PUMA trial was designed as a prospective, multicenter phase I trial to demonstrate the clinical feasibility of MR-guided online adaptive RT in LA-NSCLC. Methods Thirty patients with LA-NSCLC in stage III A-C will be accrued at three German university hospitals to receive MR-guided online adaptive RT at two different MR-linac systems (MRIdian Linac®, View Ray Inc. and Elekta Unity®, Elekta AB) with concurrent chemotherapy. Conventionally fractioned RT with isotoxic dose escalation up to 70 Gy is applied. Online plan adaptation is performed once weekly or in case of major anatomical changes. Patients are followed-up by thoracic CT- and MR-imaging for 24 months after treatment. The primary endpoint is twofold: (1) successfully completed online adapted fractions, (2) on-table time. Main secondary endpoints include adaptation frequency, toxicity, local tumor control, progression-free and overall survival. Discussion PUMA aims to demonstrate the clinical feasibility of MR-guided online adaptive RT of LA-NSCLC. If successful, PUMA will be followed by a clinical phase II trial that further investigates the clinical benefits of this approach. Moreover, PUMA is part of a large multidisciplinary project to develop MR-guidance techniques. Trial registration ClinicalTrials.gov: NCT05237453. Non-small-cell lung carcinoma (dpeaa)DE-He213 Lung Cancer (dpeaa)DE-He213 Image-guided Radiotherapy (dpeaa)DE-He213 MRI (dpeaa)DE-He213 MR-guided Radiotherapy (dpeaa)DE-He213 Adaptation (dpeaa)DE-He213 Gating (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 de Colle, Chiara aut Eze, Chukwuka aut Corradini, Stefanie aut Thieke, Christian aut Sedlaczek, Oliver aut Schlemmer, Heinz-Peter aut Dinkel, Julien aut Seith, Ferdinand aut Kopp-Schneider, Annette aut Gillmann, Clarissa aut Renkamp, C. Katharina aut Landry, Guillaume aut Thorwarth, Daniela aut Zips, Daniel aut Belka, Claus aut Jäkel, Oliver aut Debus, Jürgen aut Hörner-Rieber, Juliane aut Enthalten in Radiation oncology London : BioMed Central, 2006 18(2023), 1 vom: 04. Mai (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:18 year:2023 number:1 day:04 month:05 https://dx.doi.org/10.1186/s13014-023-02258-9 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 18 2023 1 04 05 |
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10.1186/s13014-023-02258-9 doi (DE-627)SPR050298348 (SPR)s13014-023-02258-9-e DE-627 ger DE-627 rakwb eng Regnery, Sebastian verfasserin aut Pulmonary magnetic resonance-guided online adaptive radiotherapy of locally advanced non-small-cell lung cancer: the PUMA trial 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023. corrected publication 2023 Background Patients with locally-advanced non-small-cell lung cancer (LA-NSCLC) are often ineligible for surgery, so that definitive chemoradiotherapy (CRT) represents the treatment of choice. Nevertheless, long-term tumor control is often not achieved. Intensification of radiotherapy (RT) to improve locoregional tumor control is limited by the detrimental effect of higher radiation exposure of thoracic organs-at-risk (OAR). This narrow therapeutic ratio may be expanded by exploiting the advantages of magnetic resonance (MR) linear accelerators, mainly the online adaptation of the treatment plan to the current anatomy based on daily acquired MR images. However, MR-guidance is both labor-intensive and increases treatment times, which raises the question of its clinical feasibility to treat LA-NSCLC. Therefore, the PUMA trial was designed as a prospective, multicenter phase I trial to demonstrate the clinical feasibility of MR-guided online adaptive RT in LA-NSCLC. Methods Thirty patients with LA-NSCLC in stage III A-C will be accrued at three German university hospitals to receive MR-guided online adaptive RT at two different MR-linac systems (MRIdian Linac®, View Ray Inc. and Elekta Unity®, Elekta AB) with concurrent chemotherapy. Conventionally fractioned RT with isotoxic dose escalation up to 70 Gy is applied. Online plan adaptation is performed once weekly or in case of major anatomical changes. Patients are followed-up by thoracic CT- and MR-imaging for 24 months after treatment. The primary endpoint is twofold: (1) successfully completed online adapted fractions, (2) on-table time. Main secondary endpoints include adaptation frequency, toxicity, local tumor control, progression-free and overall survival. Discussion PUMA aims to demonstrate the clinical feasibility of MR-guided online adaptive RT of LA-NSCLC. If successful, PUMA will be followed by a clinical phase II trial that further investigates the clinical benefits of this approach. Moreover, PUMA is part of a large multidisciplinary project to develop MR-guidance techniques. Trial registration ClinicalTrials.gov: NCT05237453. Non-small-cell lung carcinoma (dpeaa)DE-He213 Lung Cancer (dpeaa)DE-He213 Image-guided Radiotherapy (dpeaa)DE-He213 MRI (dpeaa)DE-He213 MR-guided Radiotherapy (dpeaa)DE-He213 Adaptation (dpeaa)DE-He213 Gating (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 de Colle, Chiara aut Eze, Chukwuka aut Corradini, Stefanie aut Thieke, Christian aut Sedlaczek, Oliver aut Schlemmer, Heinz-Peter aut Dinkel, Julien aut Seith, Ferdinand aut Kopp-Schneider, Annette aut Gillmann, Clarissa aut Renkamp, C. Katharina aut Landry, Guillaume aut Thorwarth, Daniela aut Zips, Daniel aut Belka, Claus aut Jäkel, Oliver aut Debus, Jürgen aut Hörner-Rieber, Juliane aut Enthalten in Radiation oncology London : BioMed Central, 2006 18(2023), 1 vom: 04. Mai (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:18 year:2023 number:1 day:04 month:05 https://dx.doi.org/10.1186/s13014-023-02258-9 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 18 2023 1 04 05 |
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Pulmonary magnetic resonance-guided online adaptive radiotherapy of locally advanced non-small-cell lung cancer: the PUMA trial Non-small-cell lung carcinoma (dpeaa)DE-He213 Lung Cancer (dpeaa)DE-He213 Image-guided Radiotherapy (dpeaa)DE-He213 MRI (dpeaa)DE-He213 MR-guided Radiotherapy (dpeaa)DE-He213 Adaptation (dpeaa)DE-He213 Gating (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 |
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Regnery, Sebastian de Colle, Chiara Eze, Chukwuka Corradini, Stefanie Thieke, Christian Sedlaczek, Oliver Schlemmer, Heinz-Peter Dinkel, Julien Seith, Ferdinand Kopp-Schneider, Annette Gillmann, Clarissa Renkamp, C. Katharina Landry, Guillaume Thorwarth, Daniela Zips, Daniel Belka, Claus Jäkel, Oliver Debus, Jürgen Hörner-Rieber, Juliane |
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pulmonary magnetic resonance-guided online adaptive radiotherapy of locally advanced non-small-cell lung cancer: the puma trial |
title_auth |
Pulmonary magnetic resonance-guided online adaptive radiotherapy of locally advanced non-small-cell lung cancer: the PUMA trial |
abstract |
Background Patients with locally-advanced non-small-cell lung cancer (LA-NSCLC) are often ineligible for surgery, so that definitive chemoradiotherapy (CRT) represents the treatment of choice. Nevertheless, long-term tumor control is often not achieved. Intensification of radiotherapy (RT) to improve locoregional tumor control is limited by the detrimental effect of higher radiation exposure of thoracic organs-at-risk (OAR). This narrow therapeutic ratio may be expanded by exploiting the advantages of magnetic resonance (MR) linear accelerators, mainly the online adaptation of the treatment plan to the current anatomy based on daily acquired MR images. However, MR-guidance is both labor-intensive and increases treatment times, which raises the question of its clinical feasibility to treat LA-NSCLC. Therefore, the PUMA trial was designed as a prospective, multicenter phase I trial to demonstrate the clinical feasibility of MR-guided online adaptive RT in LA-NSCLC. Methods Thirty patients with LA-NSCLC in stage III A-C will be accrued at three German university hospitals to receive MR-guided online adaptive RT at two different MR-linac systems (MRIdian Linac®, View Ray Inc. and Elekta Unity®, Elekta AB) with concurrent chemotherapy. Conventionally fractioned RT with isotoxic dose escalation up to 70 Gy is applied. Online plan adaptation is performed once weekly or in case of major anatomical changes. Patients are followed-up by thoracic CT- and MR-imaging for 24 months after treatment. The primary endpoint is twofold: (1) successfully completed online adapted fractions, (2) on-table time. Main secondary endpoints include adaptation frequency, toxicity, local tumor control, progression-free and overall survival. Discussion PUMA aims to demonstrate the clinical feasibility of MR-guided online adaptive RT of LA-NSCLC. If successful, PUMA will be followed by a clinical phase II trial that further investigates the clinical benefits of this approach. Moreover, PUMA is part of a large multidisciplinary project to develop MR-guidance techniques. Trial registration ClinicalTrials.gov: NCT05237453. © The Author(s) 2023. corrected publication 2023 |
abstractGer |
Background Patients with locally-advanced non-small-cell lung cancer (LA-NSCLC) are often ineligible for surgery, so that definitive chemoradiotherapy (CRT) represents the treatment of choice. Nevertheless, long-term tumor control is often not achieved. Intensification of radiotherapy (RT) to improve locoregional tumor control is limited by the detrimental effect of higher radiation exposure of thoracic organs-at-risk (OAR). This narrow therapeutic ratio may be expanded by exploiting the advantages of magnetic resonance (MR) linear accelerators, mainly the online adaptation of the treatment plan to the current anatomy based on daily acquired MR images. However, MR-guidance is both labor-intensive and increases treatment times, which raises the question of its clinical feasibility to treat LA-NSCLC. Therefore, the PUMA trial was designed as a prospective, multicenter phase I trial to demonstrate the clinical feasibility of MR-guided online adaptive RT in LA-NSCLC. Methods Thirty patients with LA-NSCLC in stage III A-C will be accrued at three German university hospitals to receive MR-guided online adaptive RT at two different MR-linac systems (MRIdian Linac®, View Ray Inc. and Elekta Unity®, Elekta AB) with concurrent chemotherapy. Conventionally fractioned RT with isotoxic dose escalation up to 70 Gy is applied. Online plan adaptation is performed once weekly or in case of major anatomical changes. Patients are followed-up by thoracic CT- and MR-imaging for 24 months after treatment. The primary endpoint is twofold: (1) successfully completed online adapted fractions, (2) on-table time. Main secondary endpoints include adaptation frequency, toxicity, local tumor control, progression-free and overall survival. Discussion PUMA aims to demonstrate the clinical feasibility of MR-guided online adaptive RT of LA-NSCLC. If successful, PUMA will be followed by a clinical phase II trial that further investigates the clinical benefits of this approach. Moreover, PUMA is part of a large multidisciplinary project to develop MR-guidance techniques. Trial registration ClinicalTrials.gov: NCT05237453. © The Author(s) 2023. corrected publication 2023 |
abstract_unstemmed |
Background Patients with locally-advanced non-small-cell lung cancer (LA-NSCLC) are often ineligible for surgery, so that definitive chemoradiotherapy (CRT) represents the treatment of choice. Nevertheless, long-term tumor control is often not achieved. Intensification of radiotherapy (RT) to improve locoregional tumor control is limited by the detrimental effect of higher radiation exposure of thoracic organs-at-risk (OAR). This narrow therapeutic ratio may be expanded by exploiting the advantages of magnetic resonance (MR) linear accelerators, mainly the online adaptation of the treatment plan to the current anatomy based on daily acquired MR images. However, MR-guidance is both labor-intensive and increases treatment times, which raises the question of its clinical feasibility to treat LA-NSCLC. Therefore, the PUMA trial was designed as a prospective, multicenter phase I trial to demonstrate the clinical feasibility of MR-guided online adaptive RT in LA-NSCLC. Methods Thirty patients with LA-NSCLC in stage III A-C will be accrued at three German university hospitals to receive MR-guided online adaptive RT at two different MR-linac systems (MRIdian Linac®, View Ray Inc. and Elekta Unity®, Elekta AB) with concurrent chemotherapy. Conventionally fractioned RT with isotoxic dose escalation up to 70 Gy is applied. Online plan adaptation is performed once weekly or in case of major anatomical changes. Patients are followed-up by thoracic CT- and MR-imaging for 24 months after treatment. The primary endpoint is twofold: (1) successfully completed online adapted fractions, (2) on-table time. Main secondary endpoints include adaptation frequency, toxicity, local tumor control, progression-free and overall survival. Discussion PUMA aims to demonstrate the clinical feasibility of MR-guided online adaptive RT of LA-NSCLC. If successful, PUMA will be followed by a clinical phase II trial that further investigates the clinical benefits of this approach. Moreover, PUMA is part of a large multidisciplinary project to develop MR-guidance techniques. Trial registration ClinicalTrials.gov: NCT05237453. © The Author(s) 2023. corrected publication 2023 |
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