期刊
BMJ OPEN RESPIRATORY RESEARCH
卷 8, 期 1, 页码 -出版社
BMJ PUBLISHING GROUP
DOI: 10.1136/bmjresp-2020-000846
关键词
lung cancer chemotherapy; non-small cell lung cancer; thoracic surgery
资金
- National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme [PB-PG-1217-20039]
This study aims to design a randomized trial of surgery vs. non-surgery as part of multimodality treatment for stage III-N2 NSCLC, with QOL as a primary outcome. The study will recruit 66 patients and their carers, administer QOL questionnaires, and conduct semi-structured interviews to optimize recruitment and research.
Introduction Optimal treatment for 'potentially resectable' stage III-N2 non-small cell lung cancer (NSCLC) requires multimodality treatment: local treatment (surgery or radiotherapy) and systemic anticancer therapy. There is no clear evidence of superiority for survival between the two approaches and little research has explored quality of life (QOL). This study will inform the design of a phase III randomised trial of surgery versus no surgery as part of multimodality treatment for stage III-N2 NSCLC with QOL as a primary outcome. Methods and analysis Patient participants will be randomised to receive multimodality treatment (1) with surgery OR (2) without surgery. The Quintet Recruitment Intervention will be used to maximise recruitment. Eligible patients will have 'potentially resectable' N2 NSCLC and have received a multidisciplinary team recommendation for multimodality treatment. Sixty-six patients and their carers will be recruited from 8 UK centres. Patient/carer QOL questionnaires will be administered at baseline, weeks 6, 9, 12 and month 6. Semistructured interviews will be conducted. Quantitative data will be analysed descriptively and qualitative data will be analysed using framework analysis. Ethics and dissemination Ethical approval has been obtained. Results will be disseminated via publications, national bodies and networks, and patient and public involvement groups.
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