Non Small Cell Lung CancerNCT06511661
Prognostic Significance of the Uncertain Resection in NSCLC
An observational study of Non Small Cell Lung Cancer and Residual; State, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Residual; State
- What is being tested?
- Complete lymphadenectomy and Incomplete lymphadenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 3,783 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2024to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Primary non-small cell lung cancer
- With pulmonary resection
Who cannot join
- Sublobar resection
- R1/R2
- Positive highest mediastinal lymph nodes
- Operative death
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Complete lymphadenectomy, Incomplete lymphadenectomy
- Keywords
- Non-small cell lung cancer, Lymphadenectomy, R stage
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete lymphadenectomyProcedure or surgery
At least 3 N1 stations and 3 N2 stations are examined during surgery, including station 7.
Incomplete lymphadenectomyProcedure or surgery
Less than 3 N1 stations or 3 N2 stations are examined during surgery, or those without station 7 lymph node dissection.
| Study group | Role | What they receive |
|---|---|---|
| R0 group | Patients with NSCLC who underwent R0 surgery according to the R stage proposed by IASLC. Receives: Procedure: Complete lymphadenectomy | |
| R(un) group | Patients with NSCLC who underwent R(un) surgery according to the R stage proposed by IASLC. Receives: Procedure: Incomplete lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year disease-free survival
The disease-free survival rate 5 years after surgery
Measured: 5 years after surgery
5-year overall survival
The overall survival rate 5 years after surgery
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start16 Jul 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,783 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mu-Zi Yang, Sun Yat-sen University
- Investigators
- Mu-Zi Yang, M.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511661
- Sponsor's protocol ID
- B2024-401
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06511661
- Acronym / sponsor ID
- B2024-401
- Conditions
- Non Small Cell Lung Cancer, Residual; State
- Keywords
- Non-small cell lung cancer, Lymphadenectomy, R stage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,783 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R0 group | – | Procedure: Complete lymphadenectomyPatients with NSCLC who underwent R0 surgery according to the R stage proposed by IASLC. |
| R(un) group | – | Procedure: Incomplete lymphadenectomyPatients with NSCLC who underwent R(un) surgery according to the R stage proposed by IASLC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Primary non-small cell lung cancer
- With pulmonary resection
Key exclusion criteria (4 listed)
- Sublobar resection
- R1/R2
- Positive highest mediastinal lymph nodes
- Operative death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete lymphadenectomyAt least 3 N1 stations and 3 N2 stations are examined during surgery, including station 7. | Procedure or surgery | R0 group |
| Incomplete lymphadenectomyLess than 3 N1 stations or 3 N2 stations are examined during surgery, or those without station 7 lymph node dissection. | Procedure or surgery | R(un) group |
Primary outcome
5-year disease-free survival
Time frame: 5 years after surgery
The disease-free survival rate 5 years after surgery
5-year overall survival
Time frame: 5 years after surgery
The overall survival rate 5 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mu-Zi Yang, M.D. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer and Residual; State, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year disease-free survival (time frame: 5 years after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.