{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T09:08:24Z","timestamp":1789722504781,"version":"4.0.1"},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,2,24]],"date-time":"2024-02-24T00:00:00Z","timestamp":1708732800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,2,24]],"date-time":"2024-02-24T00:00:00Z","timestamp":1708732800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Cancer"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Advanced pancreatic cancer is one of the leading causes of cancer-related deaths. For patients with advanced pancreatic cancer, gemcitabine and nanoparticle albumin-binding paclitaxel (nabPTX) combination (GEM\/nabPTX) therapy is one of the recommended first-line treatments. Several retrospective studies have suggested that the addition of levofloxacin improves the efficacy of GEM\/nabPTX therapy in patients with advanced pancreatic cancer. This prospective study aims to evaluate whether the addition of antibiotics improves the treatment efficacy of GEM\/nabPTX as a first-line chemotherapy in patients with advanced pancreatic cancer.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This multicenter, prospective, randomized, phase 2 trial will included 140 patients. Patients with advanced pancreatic cancer will be randomized in a 1:1 ratio to either the GEM\/nabPTX therapy group or the GEM\/nabPTX plus levofloxacin group. The primary endpoint for the two groups is median progression-free survival time (mPFS) for the full analysis set (FAS). The secondary endpoints for the two groups are median overall survival (mOS), response rate (RR), disease control rate (DCR), and adverse event (AE) for the FAS and mPFS, mOS, RR, DCR, and AE for the per-protocol set. This study will enroll patients treated with GEM\/nabPTX as the first-line chemotherapy for stage IV pancreatic adenocarcinoma.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>GEM\/nabPTX is a standard first-line chemotherapy regimen for patients with advanced pancreatic cancer. Recently, the superiority of 5-fluorouracil, liposomal irinotecan, and oxaliplatin combination therapy (NALIRIFOX) to GEM\/nabPTX as first-line therapy for pancreatic cancer has been reported. However, the efficacy of NALIRIFOX is inadequate. Based on previous retrospective studies, it is hypothesized that treatment efficacy will improve when levofloxacin is added to GEM\/nabPTX therapy. If the AEs (such as leukopenia, neutropenia, and peripheral neuropathy) that occur at an increased rate with levofloxacin and GEM\/nabPTX combination therapy can be carefully monitored and properly managed, this simple intervention can be expected to improve the prognosis of patients with advanced pancreatic cancer.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>This study was registered with the Japan Registry of Clinical Trials (jRCT; registry number: jRCTs021230005).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12885-024-11973-9","type":"journal-article","created":{"date-parts":[[2024,2,24]],"date-time":"2024-02-24T12:02:09Z","timestamp":1708776129000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Efficacy of adding levofloxacin to gemcitabine and nanoparticle-albumin-binding paclitaxel combination therapy in patients with advanced pancreatic cancer: study protocol for a multicenter, randomized phase 2 trial (T-CORE2201)"],"prefix":"10.1186","volume":"24","author":[{"given":"Hiroo","family":"Imai","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhiro","family":"Sakamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shin","family":"Takahashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Shibata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsushi","family":"Sato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazunori","family":"Otsuka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Amagai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masanobu","family":"Takahashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuhiro","family":"Yamaguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chikashi","family":"Ishioka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,2,24]]},"reference":[{"issue":"3","key":"11973_CR1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2023.4254","volume":"6","author":"DJ Fulop","year":"2023","unstructured":"Fulop DJ, Zylberberg HM, Wu YL, Aronson A, Labiner AJ, Wisnivesky J, Cohen DJ, Sigel KM, Lucas AL. Association of Antibiotic Receipt With Survival Among Patients With Metastatic Pancreatic Ductal Adenocarcinoma Receiving Chemotherapy. JAMA Netw Open. 2023;6(3): e234254.","journal-title":"JAMA Netw Open"},{"issue":"10","key":"11973_CR2","doi-asserted-by":"publisher","first-page":"1229","DOI":"10.1158\/2767-9764.CRC-22-0190","volume":"2","author":"LE Kane","year":"2022","unstructured":"Kane LE, Mellotte GS, Mylod E, O\u2019Brien RM, O\u2019Connell F, Buckley CE, Arlow J, Nguyen K, Mockler D, Meade AD, et al. Diagnostic Accuracy of Blood-based Biomarkers for Pancreatic Cancer: A Systematic Review and Meta-analysis. 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Aust Prescr. 2021;44(5):161\u20134.","journal-title":"Aust Prescr"}],"container-title":["BMC Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12885-024-11973-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12885-024-11973-9\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12885-024-11973-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,2,24]],"date-time":"2024-02-24T12:02:11Z","timestamp":1708776131000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmccancer.biomedcentral.com\/articles\/10.1186\/s12885-024-11973-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,24]]},"references-count":19,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["11973"],"URL":"https:\/\/doi.org\/10.1186\/s12885-024-11973-9","relation":{},"ISSN":["1471-2407"],"issn-type":[{"value":"1471-2407","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2,24]]},"assertion":[{"value":"20 June 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 February 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 February 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The trial will be conducted in accordance with the principles of the Declaration of Helsinki and approved by Tohoku Certified Review Board of Tohoku University (approved number: 2022\u20136-085, approval date: January 31, 2023). The trial is registered with the Japan Registry of Clinical Trials (jRCT; registry number: jRCTs021230005). Informed consent from each patient will be obtained by the principal investigator or co-investigators using an informed consent document. After obtaining written informed consent from the subjects, the principal investigator or co-investigator will confirm that the research participants meet all inclusion criteria.An Efficacy and Safety Monitoring Committee will be formed to determine the need to continue the trial if severe AEs associated with the treatment protocol occur.The results of this trial will be submitted to international peer-reviewed journals, and the main findings will be presented at international scientific conferences. Authorship is assigned according to the guidelines of the International Committee of Medical Journal Editors.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Chikashi Ishioka received a research funding from Tokyo Cooperative Oncology Group. Chikashi Ishioka also received contributions from Chugai Pharmaceutical; Novartis Pharma K.K.; Ono Pharmaceutical; MSD; Pfizer; AstraZeneca; Bristol-Myers Squibb; Kyowa Kirin Co., Ltd.; Janssen Pharmaceutical; Taiho Pharmaceutical; Daiichi Sankyo Company, Ltd.; Takeda Pharmaceutical; Merck Biopharma Co., Ltd.; Eli Lilly Japan K. K.; Bayer Yakuhin, Ltd.; and Incyte Biosciences Japan G.K. Chikashi Ishioka is a representative of the Tohoku Clinical Oncology Research and Education Society, a specified nonprofit corporation. Takuhiro Yamaguchi was a member of an endowed course established at the University of Tokyo and received income from the operating expenses of the endowed course until 2022. Donors for the endowed course included Nipro, Ltd. The other authors declare that they have no conflicts of interest.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"262"}}