Prognostic Significance of the Uncertain Resection in NSCLC

Active, not recruiting

• Conditions: Non Small Cell Lung Cancer; Residual; State
• Interventions: Procedure: Complete lymphadenectomy; Procedure: Incomplete lymphadenectomy

• Registration Number: NCT06511661
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The concept of residual tumor classification proposed by the Union for International Cancer Control (UICC) was used to assess the completeness of surgical resection, and non-small cell lung cancer (NSCLC) patients with incomplete resection were more likely to occur recurrence, leading to significantly poor survival. But this R classification only refers to the surgical margin and neglects other factors associated with surgical quality, such as the extent of lymph node dissection (LND). Therefore, the International Association for the Study of Lung Cancer (IASLC) proposed the definition of uncertain resection \[R(un)\], which includes the suboptimal extent of LND. However, the clinical significance of R(un) is still controversial. On the one hand, some researches demonstrated that R(un) had definite prognostic significance, with R(un) survival stratifying between R0 and R1. On the other hand, some studies indicated that in early-stage NSCLC, the suboptimal extent of LND had no impact on survival, and the concept of R(un) might be insignificant in these patients. Even in those studies supporting the prognostic significance of R(un), which kind of patients is suitable for R(un) was still unclear. Thus, the investigators explore the impact of the R(un) on the long-term survival of patients with NSCLC using a large cohort in China, to identify those patients who could really benefit from the LND required by the R0 classification proposed by IASLC.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Study Start: 2024-07-16
• Study First Posted: 2024-07-22
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3783

Inclusion Criteria

1. Primary non-small cell lung cancer
2. With pulmonary resection

Exclusion Criteria

1. Sublobar resection
2. R1/R2
3. Positive highest mediastinal lymph nodes
4. Operative death

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
R0 group	Complete lymphadenectomy	Patients with NSCLC who underwent R0 surgery according to the R stage proposed by IASLC.
R(un) group	Incomplete lymphadenectomy	Patients with NSCLC who underwent R(un) surgery according to the R stage proposed by IASLC.

Primary Outcome Measures

Name	Time	Method
5-year disease-free survival	5 years after surgery	The disease-free survival rate 5 years after surgery
5-year overall survival	5 years after surgery	The overall survival rate 5 years after surgery

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China