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 alternati...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2024-03-01
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| Series: | Radiation Oncology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13014-024-02427-4 |
| _version_ | 1797266626029027328 |
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| author | Noriko Kishi Masahiro Yoneyama Hiroyuki Inoo Minoru Inoue Hiraku Iramina Akiyoshi Nakakura Tomohiro Ono Hideaki Hirashima Takanori Adachi Norimasa Matsushita Makoto Sasaki Takahiro Fujimoto Mitsuhiro Nakamura Yukinori Matsuo Takashi Mizowaki |
| author_facet | Noriko Kishi Masahiro Yoneyama Hiroyuki Inoo Minoru Inoue Hiraku Iramina Akiyoshi Nakakura Tomohiro Ono Hideaki Hirashima Takanori Adachi Norimasa Matsushita Makoto Sasaki Takahiro Fujimoto Mitsuhiro Nakamura Yukinori Matsuo Takashi Mizowaki |
| author_sort | Noriko Kishi |
| collection | DOAJ |
| description | 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 ). |
| first_indexed | 2024-04-25T01:03:40Z |
| format | Article |
| id | doaj.art-449d469f285d48e3925a49efb9582be6 |
| institution | Directory Open Access Journal |
| issn | 1748-717X |
| language | English |
| last_indexed | 2024-04-25T01:03:40Z |
| publishDate | 2024-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Radiation Oncology |
| spelling | doaj.art-449d469f285d48e3925a49efb9582be62024-03-10T12:18:44ZengBMCRadiation Oncology1748-717X2024-03-011911710.1186/s13014-024-02427-4Protocol 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)Noriko Kishi0Masahiro Yoneyama1Hiroyuki Inoo2Minoru Inoue3Hiraku Iramina4Akiyoshi Nakakura5Tomohiro Ono6Hideaki Hirashima7Takanori Adachi8Norimasa Matsushita9Makoto Sasaki10Takahiro Fujimoto11Mitsuhiro Nakamura12Yukinori Matsuo13Takashi Mizowaki14Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto UniversityDepartment of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto UniversityDepartment of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto UniversityDepartment of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto UniversityDepartment of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto UniversityDepartment of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto UniversityDepartment of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto UniversityDepartment of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto UniversityDepartment of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto UniversityClinical Radiology Service, Kyoto University HospitalClinical Radiology Service, Kyoto University HospitalClinical Radiology Service, Kyoto University HospitalDepartment of Information Technology and Medical Engineering, Division of Medical Physics, Graduate School of Medicine, Human Health Sciences, Kyoto UniversityDepartment of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto UniversityDepartment of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto UniversityAbstract 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 ).https://doi.org/10.1186/s13014-024-02427-4Primary lung tumourMetastatic lung tumourDeep-inspiration breath-holdAdaptive radiotherapy |
| spellingShingle | Noriko Kishi Masahiro Yoneyama Hiroyuki Inoo Minoru Inoue Hiraku Iramina Akiyoshi Nakakura Tomohiro Ono Hideaki Hirashima Takanori Adachi Norimasa Matsushita Makoto Sasaki Takahiro Fujimoto Mitsuhiro Nakamura Yukinori Matsuo Takashi Mizowaki 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) Radiation Oncology Primary lung tumour Metastatic lung tumour Deep-inspiration breath-hold Adaptive radiotherapy |
| 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) |
| 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) |
| title_fullStr | 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_full_unstemmed | 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_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) |
| 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 |
| topic | Primary lung tumour Metastatic lung tumour Deep-inspiration breath-hold Adaptive radiotherapy |
| url | https://doi.org/10.1186/s13014-024-02427-4 |
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