A Multi-Institutional, Randomized, Phase III Trial Comparing Anatomical Segmentectomy and Lobectomy for Clinical Stage IA3 Pure-Solid Non-Small-Cell Lung Cancer: West Japan Oncology Group Study WJOG16923L (STEP UP Trial).
Clin Lung Cancer
; 25(4): 384-388.e1, 2024 Jun.
Article
em En
| MEDLINE
| ID: mdl-38360496
ABSTRACT
INTRODUCTION:
Although the standard treatment for patients with resectable early-stage non-small-cell lung cancer (NSCLC) is pulmonary lobectomy, recent clinical trials have demonstrated the efficacy of anatomical segmentectomy for small-sized early-stage NSCLC measuring ≤2 cm. Segmentectomy is gaining attention as an alternative procedure to lobectomy for early-stage NSCLC. PATIENTS ANDMETHODS:
In January 2024, we have initiated a randomized phase III trial in Japan to confirm the noninferiority of anatomical segmentectomy to lobectomy in patients with peripheral clinical stage IA3 pure-solid NSCLC (tumor measuring >2 cm and ≤3 cm; consolidation-to-tumor ratio = 1.0). We plan to enroll 520 patients from 61 institutions over a period of 5 years. The primary endpoint is overall survival, and the secondary endpoints include relapse-free survival, postoperative respiratory function, proportion of patients with respiratory failure and cerebrovascular disease, cumulative incidence of death from other diseases, cumulative incidence of local recurrence, proportion of patients who undergo segmentectomy, number of resected segments, operative time, blood loss, and adverse events. This trial has been registered in the UMIN Clinical Trials Registry under the code UMIN000052064.CONCLUSIONS:
This trial will help establish a novel treatment strategy for patients with peripheral clinical stage IA3 pure-solid NSCLC.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Pneumonectomia
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Carcinoma Pulmonar de Células não Pequenas
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Neoplasias Pulmonares
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Estadiamento de Neoplasias
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
País/Região como assunto:
Asia
Idioma:
En
Revista:
Clin Lung Cancer
Assunto da revista:
NEOPLASIAS
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Japão