Segmentectomy for ground glass-dominant invasive lung cancer with tumour diameter of 2–3 cm: protocol for a single-arm, multicentre, phase III trial (ECTOP1012)

Bibliographic Details
Title: Segmentectomy for ground glass-dominant invasive lung cancer with tumour diameter of 2–3 cm: protocol for a single-arm, multicentre, phase III trial (ECTOP1012)
Authors: Yang Zhang, Shiqi Chen, Qingyuan Huang, Fangqiu Fu, Zezhou Wang, Haiquan Chen
Source: BMJ Open, Vol 14, Iss 7 (2024)
Publisher Information: BMJ Publishing Group, 2024.
Publication Year: 2024
Collection: LCC:Medicine
Subject Terms: Medicine
More Details: Introduction Previous studies demonstrated that wedge resection is sufficient for ground glass-dominant lung adenocarcinoma (LUAD) with tumour diameter ≤2 cm, however, the optimal surgical type for ground glass-dominant LUAD with tumour diameter of 2–3 cm remains unclear. The purpose of this trial is to investigate the safety and efficacy of segmentectomy for ground glass-dominant invasive LUAD with tumour size of 2–3 cm.Methods and analysis We initiated a phase III trial to investigate whether segmentectomy is suitable for ground glass-dominant invasive LUAD with tumour size of 2–3 cm. This trial plans to enrol 307 patients from multiple institutions including four general hospitals and two specialty cancer hospitals over a period of 5 years. The primary endpoint is 5 year disease-free survival. Secondary endpoints are lung function, 5 year overall survival, the site of tumour recurrence and metastasis, segmentectomy completion rate, radical segmentectomy (R0 resection) completion rate and surgery-related complications.Ethics and dissemination This trial has been approved by the Ethics Committee of Fudan University Shanghai Cancer Centre (reference 2212267-18) and by the institutional review boards of each participating centre. Written informed consent is required from all participants. The study results will be published in a peer-reviewed international journal.Trial registration number NCT05717803.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2044-6055
Relation: https://bmjopen.bmj.com/content/14/7/e087088.full; https://doaj.org/toc/2044-6055
DOI: 10.1136/bmjopen-2024-087088
Access URL: https://doaj.org/article/f5165634f9fe4ad9b8d418dde4417765
Accession Number: edsdoj.f5165634f9fe4ad9b8d418dde4417765
Database: Directory of Open Access Journals
More Details
ISSN:20446055
DOI:10.1136/bmjopen-2024-087088
Published in:BMJ Open
Language:English