Abstract | INTRODUCTION: METHODS AND ANALYSIS: This study is a multicentre, parallel group, open label, randomised controlled trial. Patients clinically suspected of non-small cell lung cancer are randomly assigned to the flurbiprofen axetil group or the no- NSAIDs group. A total of 420 patients (210 per group) will be registered. The primary analysis will evaluate the treatment effect of flurbiprofen axetil on postoperative recurrence. ETHICS AND DISSEMINATION: The study protocol was approved by the Clinical Research Review Board of Saitama Medical University in September 2019 (No. 192002) and will be approved by each institutional review board of all participating institutions before patient enrolment. This study complies with the latest version of the Declaration of Helsinki, Clinical Trial Act and related notifications. Results will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: Japan Registry of Clinical Trials (jRCTs031190167; Pre-results) (https://jrct.niph.go.jp/).
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Authors | Kentaro Sakamaki, Katsuya Watanabe, Tetsukan Woo, Munetaka Masuda |
Journal | BMJ open
(BMJ Open)
Vol. 10
Issue 11
Pg. e040969
(11 30 2020)
ISSN: 2044-6055 [Electronic] England |
PMID | 33257489
(Publication Type: Clinical Trial Protocol, Journal Article)
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Copyright | © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
Chemical References |
- Flurbiprofen
- flurbiprofen axetil
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Topics |
- Carcinoma, Non-Small-Cell Lung
(drug therapy, surgery)
- Clinical Trials, Phase II as Topic
- Flurbiprofen
(analogs & derivatives, therapeutic use)
- Humans
- Japan
- Lung Neoplasms
(drug therapy)
- Multicenter Studies as Topic
- Neoplasm Recurrence, Local
(prevention & control)
- Quality of Life
- Randomized Controlled Trials as Topic
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