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Active, Not Recruiting

NCT Number: NCT06511661

Prognostic Significance of the Uncertain Resection in NSCLC

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary non-small cell lung cancer
  • With pulmonary resection

Exclusion criteria

  • Sublobar resection
  • R1/R2
  • Positive highest mediastinal lymph nodes
  • Operative death

Treatment and study plan

Complete lymphadenectomy

Procedure

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

Incomplete lymphadenectomy

Procedure

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

Primary outcomes

  1. 5-year disease-free survival

    Time frame: 5 years after surgery

    The disease-free survival rate 5 years after surgery

  2. 5-year overall survival

    Time frame: 5 years after surgery

    The overall survival rate 5 years after surgery

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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