Clinical trial NCT06626243: Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy in Patients Performed in Five Referred Centers
Official title: An International Multicenter Retrospective Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Small Cell Lung Cancer
Keywords: Video-Assisted Thoracoscopic Surgery
Robot-Assisted Thoracoscopic Surgery
open approach
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
name: Istituto Clinico Humanitas
name: Regina Elena Cancer Institute
name: Baptist Health South Florida
name: West Virginia University
First posted: 2024-10-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosed locally advanced and resectable non-small cell lung cancer (NSCLC) who underwent lung resection from 01-01-2016 to 31-03-2024 by robotic, video-assisted thoracoscopic (VATS), and open approaches after receiving neoadjuvant chemo-immunotherapy.

Brief summary: The study is a retrospective observational study. The study is designed to be multicentric and international and it will analyze medical records from selected patients diagnosed with locally advanced and resectable NSCLC who underwent lung resection by robotic, VATS and open approach after receiving neoadjuvant chemo-immunotherapy.

There are no risks for the patients, as this is a retrospective data collection.

Detailed description: The use of neoadjuvant chemo-immunotherapy for the treatment of non-small cell lung cancer (NSCLC) is increasing. However, there is limited research comparing the feasibility and oncologic efficacy of robot-assisted thoracoscopic surgery (RATS), video-assisted thoracoscopic surgery (VATS), and open lung resection, in patients already treated with neoadjuvant chemo-immunotherapy. This study aims to evaluate the benefits of RATS compared to VATS and open surgery in terms of short-term outcomes for patients with NSCLC undergoing neoadjuvant chemo-immunotherapy.

All adult patients diagnosed with locally advanced and resectable NSCLC who underwent lung resection from 01-01-2016 to 31-03-2024 by robotic, VATS and open approach after receiving neoadjuvant chemo-immunotherapy will be included.

Patients are divided into three groups: robotic lung resection; video-assisted thoracoscopic (VATS) lung resection; open lung resection.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of clinical or pathological stage IIB (T1-2, hilar N1, M0) and III (any T, N1-2, M0) NSCLC surgically treated with robotic, VATS and open approach with radical intent from 1st of January 2016 to 31st of March 2024
* Received neoadjuvant chemo-immunotherapy or immunotherapy alone
* Age \>= 18 years old at the moment of surgery

Exclusion Criteria:

* Age \<18 years old at the moment of surgery

Primary outcomes:
measure: The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach
timeFrame: 30-90 days after surgery
measure: The perioperative complications of robotic approach
timeFrame: from the surgery at 30-90 days after
measure: The perioperative complications of the open approach
timeFrame: 30-90 days after surgery
Secondary outcomes:
measure: Duration of surgery
timeFrame: from 30 days after surgery
measure: Quality of lymphadenectomy
timeFrame: from 30 days after surgery
measure: Conversion rate
timeFrame: from 30 days after surgery
measure: Radicality of the resection
timeFrame: from 30 days after surgery
measure: Oncological treatment
timeFrame: from 30 days after surgery
measure: Survival analysis
timeFrame: from 3 to 5 years after surgery
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
city: Milan
country: Italy
facility: Scientific Institute Ospedale San Raffaele
city: Rome
country: Italy
facility: Regina Elena National Cancer Institute
Study officials:
References: