Skip to content

Prognostic Significance of the Uncertain Resection in NSCLC

Prognostic Significance of the Uncertain Resection Based on the Extent of Nodal Dissection for Non-small Cell Lung Cancer: A Propensity Score Matching Retrospective Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06511661
Enrollment
3783
Registered
2024-07-22
Start date
2024-07-16
Completion date
2025-07-31
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer, Residual; State

Keywords

Non-small cell lung cancer, Lymphadenectomy, R stage

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.

Interventions

PROCEDUREComplete lymphadenectomy

At least 3 N1 stations and 3 N2 stations are examined during surgery, including station 7.

PROCEDUREIncomplete lymphadenectomy

Less than 3 N1 stations or 3 N2 stations are examined during surgery, or those without station 7 lymph node dissection.

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
5-year disease-free survival5 years after surgeryThe disease-free survival rate 5 years after surgery
5-year overall survival5 years after surgeryThe overall survival rate 5 years after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026