Non Small Cell Lung Cancer Clinical Trial
— NUTSOfficial title:
Multicentric Analysis of Predictors of N1 Upstaging After Resection of cStage-I NSCLC
NCT number | NCT02730897 |
Other study ID # | NUTS |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | January 2017 |
Verified date | September 2019 |
Source | University Hospital, Gasthuisberg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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
Status | Completed |
Enrollment | 956 |
Est. completion date | January 2017 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Gasthuisberg |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of nodal (N1 and N2) upstaging | Incidence of nodal (N1 and N2) upstaging stratified by 'central' versus 'peripheral' tumor location | immediate postoperative | |
Secondary | Overall Survival | To compare survival after resection by open technique or VATS, stratified for the above predictors | 1 yr postoperative |
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