Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy in Patients Performed in Five Referred Centers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An International Multicenter Retrospective Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy
Overview
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.
Primary outcome measures
- The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach [Time frame: 30-90 days after surgery]
- The perioperative complications of robotic approach [Time frame: from the surgery at 30-90 days after]
- The perioperative complications of the open approach [Time frame: 30-90 days after surgery]
Secondary outcome measures (6)
- Duration of surgery [Time frame: from 30 days after surgery]
- Quality of lymphadenectomy [Time frame: from 30 days after surgery]
- Conversion rate [Time frame: from 30 days after surgery]
- Radicality of the resection [Time frame: from 30 days after surgery]
- Oncological treatment [Time frame: from 30 days after surgery]
- Survival analysis [Time frame: from 3 to 5 years after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Baptist Health South Florida — Miami
- Memorial Sloan Kettering Cancer Center — New York
- West Virginia University — Morgantown
Italy · 3 centers
- Istituto Clinico Humanitas — Rozzano
- Scientific Institute Ospedale San Raffaele — Milan
- Regina Elena National Cancer Institute — Rome
Identifiers
NCT: NCT06626243 · CET 380-2024