Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy in Patients Performed in Five Referred Centers
- Conditions
- Non-Small Cell Lung Cancer
- Registration Number
- NCT06626243
- Lead Sponsor
- Scientific Institute San Raffaele
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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
- Age <18 years old at the moment of surgery
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach 30-90 days after surgery The investigators will measure the perioperative complications of VATS approach in patients who received neoadjuvant chemo-immunotherapy. Complications will be categorized according to the Clavien-Dindo scale.
The perioperative complications of robotic approach from the surgery at 30-90 days after The investigators will measure the perioperative complications of robotic lung resection in patients who received neoadjuvant chemo-immunotherapy. Complications will be categorized according to the Clavien-Dindo scale.
The perioperative complications of the open approach 30-90 days after surgery The investigators will measure the perioperative complications of open approach in patients who received neoadjuvant chemo-immunotherapy. Complications will be categorized according to the Clavien-Dindo scale.
- Secondary Outcome Measures
Name Time Method Duration of surgery from 30 days after surgery Duration of the surgery based on the approach measured in minutes
Quality of lymphadenectomy from 30 days after surgery Number of lymphonodes station resected
Conversion rate from 30 days after surgery Number of surgery procedures converted
Radicality of the resection from 30 days after surgery Radicality of the resection in the approaches
Oncological treatment from 30 days after surgery Response of the patient to oncological treatment
Survival analysis from 3 to 5 years after surgery Presence or absence of local and distant relapse
Trial Locations
- Locations (6)
Scientific Institute Ospedale San Raffaele
🇮🇹Milan, Italy
Regina Elena National Cancer Institute
🇮🇹Rome, Italy
Baptist Health South Florida
🇺🇸Miami, Florida, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Istituto Clinico Humanitas
🇮🇹Rozzano, Milan, Italy