Non Small Cell Lung CancerNUTSNCT02730897
Multicentric Analysis of Predictors of N1 Upstaging After Resection of cStage-I NSCLC
An observational study of Non Small Cell Lung Cancer, run by University Hospital, Gasthuisberg.
Trial summary
Five papers showed a lower N1 nodal upstaging with video-assisted thoracic surgery (VATS) compared to open surgery in patients with cStage-I NSCLC . This finding questions the oncologic quality of minimal invasive lung cancer surgery, especially the quality of hilar and intrapulmonary lymh node dissection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Central/Peripheral
- Type of treatment
- Surgery or procedure
- How many people
- 956 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2017
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Per centre, a list of consecutive patients operated for cStage-I NSCLC in 2014 is selected. cStage-I is decided based on all information before resection is started in accordance to the 7th edition of TNM
Who may be able to join
- Patients operated in 2014
- NSCLC on final pathology
- cStage-I (cT1-2a cN0 cM0 ) before start of incision for anatomical resection.
- This includes: open/VATS/ Robotic Assisted Thoracoscopic Surgery (RATS)
- This includes: lobectomy, bilobectomy, sleeve or pneumonectomy (not wedge)
Who cannot join
- Higher clinical stage than cStage-I
- Former therapy for lung cancer (chemotherapy, radiotherapy, surgery)
- Metastatic disease
- Induction chemo- or radiotherapy
- Non-anatomical resections (wedge)
- Previous lymph node disease
- No positron emission tomography (PET) or Missing PET report
About this study
Five papers showed a lower N1 nodal upstaging with video-assisted thoracic surgery (VATS) compared to open surgery in patients with cStage-I NSCLC . This finding questions the oncologic quality of minimal invasive lung cancer surgery, especially the quality of hilar and intrapulmonary lymh node dissection. However, these retrospective studies did not include analysis of central tumor location, although central tumors have a reported higher chance of N1 upstaging . Possibly, this creates a selection bias as surgeons might select central lesions deliberately for open surgery in line with initial VATS feasibility reports
Read the detailed description
After optimal preoperative staging, 10 to 25% of patients with clinical stage I (cStage-I) non-small cell lung cancer (NSCLC) are found to have unforeseen positive lymph nodes during resection.
Central tumors, even if they are smaller than 3cm (cT1), have a higher incidence of both intrapulmonary or hilar (N1) or ipsilateral mediastinal (N2) lymph node involvement in comparison to peripheral lesions.
In a cohort of patients that underwent identical preoperative mediastinal evaluation and postoperative pathologic tissue examination of equal quality, nodal upstaging can be used as a quality indicator of oncologic thoracic surgery. Or, it can be used as an instrument to compare different techniques, such as thoracoscopic (VATS) versus open lung resections for lung cancer.
Five papers showed a lower N1 nodal upstaging with video-assisted thoracic surgery (VATS) compared to open surgery. These retrospective studies did not include tumor location.
The investigators hypothesize that this creates a bias as surgeons might have chosen an open approach when the tumor was centrally located. This is in line with initial feasibility reports and guidelines that excluded patients with central lesions. This results in a higher prevalence of positive N1 nodes in patients operated with the open approach.
Our single centre analysis showed a one in three chance of nodal upstaging in central located cStage-I tumors , multivariate analysis showed central location to be the only significant predictor for upstaging, and not the surgical technique.
The aim of this multicentric study is to investigate risk factors for nodal upstaging, including tumor location, in patients with cStage-I NSCLC and validate previous findings.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Central/Peripheral
- Keywords
- Surgery, Thoracotomy, VATS
- 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.
Central/PeripheralProcedure or surgery
Central versus peripheral location of the primary tumor
| Study group | Role | What they receive |
|---|---|---|
| VATS | Patients operated by means of minimal invasive technique (VATS or roboticVATS) Receives: Procedure: Central/Peripheral | |
| Open | Patients operated by means of open thoracotomy Receives: Procedure: Central/Peripheral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nodal (N1 and N2) upstaging
Incidence of nodal (N1 and N2) upstaging stratified by 'central' versus 'peripheral' tumor location
Measured: immediate postoperative
Secondary outcomes (1)
Overall Survival
To compare survival after resection by open technique or VATS, stratified for the above predictors
Measured: 1 yr postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionJan 2017
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.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 956 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnny Moons, University Hospital, Gasthuisberg
- Investigators
- Herbert Decaluwé, MD, Study director, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730897
- Sponsor's protocol ID
- NUTS
- Acronym
- NUTS
- Status last verified
- Sep 2019
- First submitted
- 21 Mar 2016
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Analysis of Predictors of N1 Upstaging After Resection of cStage-I NSCLC
- ClinicalTrials.gov ID
- NCT02730897
- Acronym / sponsor ID
- NUTS / NUTS
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Surgery, Thoracotomy, VATS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 956 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 7 Apr 2016 (estimated)
- 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.
Five papers showed a lower N1 nodal upstaging with video-assisted thoracic surgery (VATS) compared to open surgery in patients with cStage-I NSCLC . This finding questions the oncologic quality of minimal invasive lung cancer surgery, especially the quality of hilar and intrapulmonary lymh node dissection. However, these retrospective studies did not include analysis of central tumor location, although central tumors have a reported higher chance of N1 upstaging . Possibly, this creates a selection bias as surgeons might select central lesions deliberately for open surgery in line with initial VATS feasibility reports
Detailed description
After optimal preoperative staging, 10 to 25% of patients with clinical stage I (cStage-I) non-small cell lung cancer (NSCLC) are found to have unforeseen positive lymph nodes during resection.
Central tumors, even if they are smaller than 3cm (cT1), have a higher incidence of both intrapulmonary or hilar (N1) or ipsilateral mediastinal (N2) lymph node involvement in comparison to peripheral lesions.
In a cohort of patients that underwent identical preoperative mediastinal evaluation and postoperative pathologic tissue examination of equal quality, nodal upstaging can be used as a quality indicator of oncologic thoracic surgery. Or, it can be used as an instrument to compare different techniques, such as thoracoscopic (VATS) versus open lung resections for lung cancer.
Five papers showed a lower N1 nodal upstaging with video-assisted thoracic surgery (VATS) compared to open surgery. These retrospective studies did not include tumor location.
The investigators hypothesize that this creates a bias as surgeons might have chosen an open approach when the tumor was centrally located. This is in line with initial feasibility reports and guidelines that excluded patients with central lesions. This results in a higher prevalence of positive N1 nodes in patients operated with the open approach.
Our single centre analysis showed a one in three chance of nodal upstaging in central located cStage-I tumors , multivariate analysis showed central location to be the only significant predictor for upstaging, and not the surgical technique.
The aim of this multicentric study is to investigate risk factors for nodal upstaging, including tumor location, in patients with cStage-I NSCLC and validate previous findings.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VATS | – | Procedure: Central/PeripheralPatients operated by means of minimal invasive technique (VATS or roboticVATS) |
| Open | – | Procedure: Central/PeripheralPatients operated by means of open thoracotomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Per centre, a list of consecutive patients operated for cStage-I NSCLC in 2014 is selected. cStage-I is decided based on all information before resection is started in accordance to the 7th edition of TNM
Key inclusion criteria (5 listed)
- Patients operated in 2014
- NSCLC on final pathology
- cStage-I (cT1-2a cN0 cM0 ) before start of incision for anatomical resection.
- This includes: open/VATS/ Robotic Assisted Thoracoscopic Surgery (RATS)
- This includes: lobectomy, bilobectomy, sleeve or pneumonectomy (not wedge)
Key exclusion criteria (7 listed)
- Higher clinical stage than cStage-I
- Former therapy for lung cancer (chemotherapy, radiotherapy, surgery)
- Metastatic disease
- Induction chemo- or radiotherapy
- Non-anatomical resections (wedge)
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 |
|---|---|---|
| Central/PeripheralCentral versus peripheral location of the primary tumor | Procedure or surgery | Open, VATS |
Primary outcome
Incidence of nodal (N1 and N2) upstaging
Time frame: immediate postoperative
Incidence of nodal (N1 and N2) upstaging stratified by 'central' versus 'peripheral' tumor location
1 secondary outcome
Overall Survival
Time frame: 1 yr postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Herbert Decaluwé, MD study director
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by University Hospital, Gasthuisberg.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of nodal (N1 and N2) upstaging (time frame: immediate postoperative). 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 Sep 2019.