Prognostic Significance of the Uncertain Resection in NSCLC

NCT ID: NCT06511661

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 3783 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-16
• Study Completion Date: 2025-07-31

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.

Conditions

Non Small Cell Lung Cancer; Residual; State

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

R0 group

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

Complete lymphadenectomy

Intervention Type: PROCEDURE

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

R(un) group

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

Incomplete lymphadenectomy

Intervention Type: PROCEDURE

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

Interventions

Complete lymphadenectomy

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

Intervention Type: PROCEDURE

Incomplete lymphadenectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Mu-Zi Yang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mu-Zi Yang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

B2024-401

Identifier Type: -

Identifier Source: org_study_id