Prognostic Significance of the Uncertain Resection in NSCLC

Sun Yat-sen University

Status: Active, not recruiting

Conditions: Non Small Cell Lung Cancer; Residual; State

Treatments: Procedure: Complete lymphadenectomy; Procedure: Incomplete lymphadenectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06511661

B2024-401

Details and patient eligibility

About

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.

Enrollment: 3,783 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,783 participants in 2 patient groups

R0 group

Description:

Patients with NSCLC who underwent R0 surgery according to the R stage proposed by IASLC.

Treatment:

Procedure: Complete lymphadenectomy

R(un) group

Description:

Patients with NSCLC who underwent R(un) surgery according to the R stage proposed by IASLC.

Treatment:

Procedure: Incomplete lymphadenectomy