Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634979
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer with the CTR of 05-1 and the Diameter of 2 Cm
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer with the CTR of 05-1 and the Diameter of 2 Cm a Prospective Single-arm Multi-center Phase Ⅱ Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study investigated the efficacy and safety of a sex-selective lymph node strategy no lower mediastinal lymph node clearance for upper lobe tumors and no upper mediastinal lymph node clearance for lower lobe tumors in patients with 05 CTR 1 and 2 cm in diameter cT1N0M0 infiltrating NSCLC aiming to more accurately assess the prognosis of the selective lymph node dissection strategy for nodes with 05 CTR 1 and 2 cm in diameter
Detailed Description:
Selective lymph node dissection is an important idea to reduce the trauma of mediastinal lymph node dissection in early clinical patients In a previous study our team proposed a predictive model for mediastinal lymph node metastasis in patients with clinical T1N0 non-small cell lung cancer and found that age tumor size central type and pathologic subtype were closely related to mediastinal lymph node metastasis In addition our team found that adenocarcinoma in situ AIS minimally invasive adenocarcinoma MIA and invasive adenocarcinoma with predominantly adherent subtype LPA did not have mediastinal lymph node metastasis and lymph node dissection was not necessary for such patients In addition by retrospectively studying nearly 3000 cases of stage I-III NSCLC we found that NSCLCs in the apical segments do not metastasize to the lower mediastinum whereas in N1 lymph node-negative patients with negative pleural invasion tumors in segments of the upper lobes do not metastasize to the lower mediastinal lymph nodes On this basis we conducted the first international prospective phase II clinical trial of a selective lymph node dissection strategy to validate the clinical feasibility of a selective lymph node dissection strategy The main objective of this study was to develop a selective lymph node dissection strategy for cT1NOM0 invasive NSCLC with a diameter of 2 cm ie no lower mediastinal lymph node dissection for tumors located in the upper lobe and no upper mediastinal lymph node dissection for tumors located in the lower lobe Further we retrospectively analyzed 7067 NSCLC cases with systematic lymph node dissection from April 2008 to July 2022 in which the rate of mediastinal lymph node metastasis was 154 10917067 and there was no lymph node metastasis in 209 cases of AISMIALPA whereas in other subtypes of adenocarcinomas the rate of mediastinal lymph node metastasis was 153 106 695 Among them we retrospectively analyzed 360 cases of cT1N0M0 non-small cell lung cancer with 05 CTR 10 and found that among them tumors located in the upper lobe had no lower mediastinal lymph node metastasis and tumors located in the lower lobe had no metastasis in the upper mediastinal lymph nodes For other non-small cell lung cancers with 05 CTR 10 if the VPI was negative no lower mediastinal metastasis was also observed in tumors in the upper lobe and no upper mediastinal metastasis was observed in tumors in the lower lobe In 212 cases of lung cancer not exceeding 1 cm in size there were no lower mediastinal metastases in tumors in the upper lobe and no upper mediastinal metastases in tumors in the lower lobe
The study investigated the efficacy and safety of a sex-selective lymph node strategy no lower mediastinal lymph node clearance for upper lobe tumors and no upper mediastinal lymph node clearance for lower lobe tumors in patients with 05 CTR 1 and 2 cm in diameter cT1N0M0 infiltrating NSCLC aiming to more accurately assess the prognosis of the selective lymph node dissection strategy for nodes with 05 CTR 1 and 2 cm in diameter
The study investigated the efficacy and safety of a sex-selective lymph node strategy no lower mediastinal lymph node clearance for upper lobe tumors and no upper mediastinal lymph node clearance for lower lobe tumors in patients with 05 CTR 1 and 2 cm in diameter cT1N0M0 infiltrating NSCLC aiming to more accurately assess the prognosis of the selective lymph node dissection strategy for nodes with 05 CTR 1 and 2 cm in diameter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None