{"created":"2023-05-15T16:49:19.696458+00:00","id":26731,"links":{},"metadata":{"_buckets":{"deposit":"589d71b0-dbc1-484c-adc7-603243895758"},"_deposit":{"created_by":6,"id":"26731","owners":[6],"pid":{"revision_id":0,"type":"depid","value":"26731"},"status":"published"},"_oai":{"id":"oai:nagasaki-u.repo.nii.ac.jp:00026731","sets":["10:11"]},"author_link":["118362","118359","118360","118363","118358","118355","118361","118356","118364","118357"],"item_2_biblio_info_6":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2021-03-08","bibliographicIssueDateType":"Issued"},"bibliographicPageStart":"art. no. 249","bibliographicVolumeNumber":"21","bibliographic_titles":[{"bibliographic_title":"BMC Cancer"}]}]},"item_2_description_4":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"Background: The current standard postoperative treatment for stage II-IIIA non-small cell lung cancer (NSCLC) is a regimen of platinum doublet adjuvant chemotherapy. These regimens, which are the same as for solid NSCLC tumors, often cause severe adverse reactions in the treated patients. Therefore, an effective treatment regimen with fewer side effects is needed.\nMethods/design: The purpose of this study is to evaluate the effectiveness and safety of S-1 monotherapy (80 mg/m2 orally administrated twice daily, at day 1–14, 16 cycles) and cisplatin with vinorelbine combination therapy (cisplatin 80 mg/m2 at day 1,vinorelbine 25 mg/m2 at day 1, 8, 4 cycles) in patients with II/IIIA stage non-small-cell lung cancer who underwent a total resection. In addition, we will also evaluate the level of treatment side effects by assessing quality of life (QOL), work productivity and activity performance. The primary endpoint is a 2-year relapse free survival (RFS) and the second primary endpoints are 2-year overall survival (OS), rate of treatment completion, safety, work productivity and activity, and quality of adjusted life years (QALY). At the same time, we aim to obtain precise information required to perform future phase 3 randomized controlled trials. The study is designed to estimate the primary endpoint with accuracy determined as the width of its 95% confidence interval to be less than 20%. Recruitment started in May 2017 and is ongoing.\nDiscussion: This study has been conceived to establish a superior regimen for completely resected NSCLC based on efficacy, safety and QOL.\nTrial registration: Registry number: UMIN000027435. Registered May 22, 2017.","subitem_description_type":"Abstract"}]},"item_2_description_63":{"attribute_name":"引用","attribute_value_mlt":[{"subitem_description":"BMC Cancer, 21, art. no. 249; 2021","subitem_description_type":"Other"}]},"item_2_publisher_33":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"BioMed Central Ltd"}]},"item_2_relation_12":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_relation_type":"isIdenticalTo","subitem_relation_type_id":{"subitem_relation_type_id_text":"10.1186/s12885-021-07945-y","subitem_relation_type_select":"DOI"}}]},"item_2_rights_13":{"attribute_name":"権利","attribute_value_mlt":[{"subitem_rights":"© The Author(s). 2021 Open Access This 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/. The Creative Commons Public Domain Dedication waiver (http://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."}]},"item_2_source_id_8":{"attribute_name":"EISSN","attribute_value_mlt":[{"subitem_source_identifier":"1471-2407","subitem_source_identifier_type":"ISSN"}]},"item_2_version_type_16":{"attribute_name":"著者版フラグ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"Tsuchiya, Tomoshi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Matsumoto, Keitaro"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Miyazaki, Takuro"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Doi, Ryoichiro"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Tokunaga, Shoji"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Yamaguchi, Hiroyuki"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Tomoshige, Koichi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Watanabe, Hironosuke"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Nagayasu, Takeshi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Sugio, Kenji"}],"nameIdentifiers":[{}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_date","date":[{"dateType":"Available","dateValue":"2021-09-21"}],"displaytype":"detail","filename":"BMCC21_249.pdf","filesize":[{"value":"921.7 kB"}],"format":"application/pdf","licensetype":"license_note","mimetype":"application/pdf","url":{"label":"BMCC21_249.pdf","url":"https://nagasaki-u.repo.nii.ac.jp/record/26731/files/BMCC21_249.pdf"},"version_id":"481a46a0-92a2-49cb-91f1-c5cdb1857669"}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"Adjuvant chemotherapy","subitem_subject_scheme":"Other"},{"subitem_subject":"S-1","subitem_subject_scheme":"Other"},{"subitem_subject":"Cisplatin","subitem_subject_scheme":"Other"},{"subitem_subject":"Feasibility study","subitem_subject_scheme":"Other"},{"subitem_subject":"Quality of life non-small cell lung cancer","subitem_subject_scheme":"Other"}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"eng"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"A randomized phase II study of S-1 monotherapy versus cisplatin with vinorelbine for completely resected stage II/IIIA non-small cell lung cancer: rationale and study protocol design for the LOGIK1702 study","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"A randomized phase II study of S-1 monotherapy versus cisplatin with vinorelbine for completely resected stage II/IIIA non-small cell lung cancer: rationale and study protocol design for the LOGIK1702 study"}]},"item_type_id":"2","owner":"6","path":["11"],"pubdate":{"attribute_name":"公開日","attribute_value":"2021-09-21"},"publish_date":"2021-09-21","publish_status":"0","recid":"26731","relation_version_is_last":true,"title":["A randomized phase II study of S-1 monotherapy versus cisplatin with vinorelbine for completely resected stage II/IIIA non-small cell lung cancer: rationale and study protocol design for the LOGIK1702 study"],"weko_creator_id":"6","weko_shared_id":-1},"updated":"2023-05-15T20:13:20.769401+00:00"}