Sublobar resection for adenocarcinoma
Adenocarcinoma in situ (AIS)
intraoperative frozen section (FS)
minimally invasive adenocarcinoma (MIA)
sublobar resection
Journal
Journal of thoracic disease
ISSN: 2072-1439
Titre abrégé: J Thorac Dis
Pays: China
ID NLM: 101533916
Informations de publication
Date de publication:
30 Sep 2024
30 Sep 2024
Historique:
received:
14
04
2024
accepted:
02
08
2024
medline:
24
10
2024
pubmed:
24
10
2024
entrez:
24
10
2024
Statut:
ppublish
Résumé
Our previous retrospective study revealed that sublobar resection was appropriate for adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) diagnosed by intraoperative frozen section (FS). However, high-level evidence-based medical data confirming this treatment are still lacking. The aim of the ongoing study is to confirm the efficacy and safety of sublobar resection for AIS and MIA diagnosed by FS. Since October 2023, we have initiated a prospective, single-arm, multicenter, confirmatory phase III trial in China. We plan to enroll a total of 390 patients diagnosed as AIS or MIA by intraoperative FS and who will undergo sublobar resection. The primary endpoint is five-year recurrence-free survival; the secondary endpoints are five-year overall survival, the concordance rate between FS and final pathology, adverse events, proportion of local recurrence and metastasis, the completion rate of sublobar resection and R0 resection. Surgical strategies for small-sized lung cancer that contains ground glass opacity lesions are still controversial. This study will deliver new evidence on the efficacy and safety of sublobar resection without lymph node dissection for cT1N0M0 non-small cell lung cancer (NSCLC) which are diagnosed as AIS or MIA by FS. ClinicalTrials.gov identifier: NCT06031181.
Sections du résumé
Background
UNASSIGNED
Our previous retrospective study revealed that sublobar resection was appropriate for adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) diagnosed by intraoperative frozen section (FS). However, high-level evidence-based medical data confirming this treatment are still lacking. The aim of the ongoing study is to confirm the efficacy and safety of sublobar resection for AIS and MIA diagnosed by FS.
Methods
UNASSIGNED
Since October 2023, we have initiated a prospective, single-arm, multicenter, confirmatory phase III trial in China. We plan to enroll a total of 390 patients diagnosed as AIS or MIA by intraoperative FS and who will undergo sublobar resection. The primary endpoint is five-year recurrence-free survival; the secondary endpoints are five-year overall survival, the concordance rate between FS and final pathology, adverse events, proportion of local recurrence and metastasis, the completion rate of sublobar resection and R0 resection.
Discussion
UNASSIGNED
Surgical strategies for small-sized lung cancer that contains ground glass opacity lesions are still controversial. This study will deliver new evidence on the efficacy and safety of sublobar resection without lymph node dissection for cT1N0M0 non-small cell lung cancer (NSCLC) which are diagnosed as AIS or MIA by FS.
Trial Registration
UNASSIGNED
ClinicalTrials.gov identifier: NCT06031181.
Identifiants
pubmed: 39444881
doi: 10.21037/jtd-24-623
pii: jtd-16-09-6286
pmc: PMC11494530
doi:
Banques de données
ClinicalTrials.gov
['NCT06031181']
Types de publication
Journal Article
Langues
eng
Pagination
6286-6291Informations de copyright
2024 AME Publishing Company. All rights reserved.
Déclaration de conflit d'intérêts
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-623/coif). H.C. serves as an unpaid editorial board member of Journal of Thoracic Disease from October 2022 to September 2024. The other authors have no conflicts of interest to declare.