Prognostic Significance of the Uncertain Resection in NSCLC

July 24, 2024 updated by: Mu-Zi Yang, Sun Yat-sen University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3783

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The data of included patients is extracted from the Hospital Information System of Sun Yat-sen University Cancer Center from 2001 to 2024.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
R0 group
Patients with NSCLC who underwent R0 surgery according to the R stage proposed by IASLC.
Procedure: Complete lymphadenectomy
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.
Procedure: Incomplete lymphadenectomy
Less than 3 N1 stations or 3 N2 stations are examined during surgery, or those without station 7 lymph node dissection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year disease-free survival
Time Frame: 5 years after surgery
The disease-free survival rate 5 years after surgery
5 years after surgery
5-year overall survival
Time Frame: 5 years after surgery
The overall survival rate 5 years after surgery
5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Mu-Zi Yang, M.D., Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 15, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2024-401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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