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Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy in Patients Performed in Five Referred Centers

An International Multicenter Retrospective Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06626243
Acronym
IMMUNORATS
Enrollment
140
Registered
2024-10-03
Start date
2024-09-30
Completion date
2025-10-15
Last updated
2024-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

Video-Assisted Thoracoscopic Surgery, Robot-Assisted Thoracoscopic Surgery, open approach

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.

Interventions

None listed

Sponsors

Memorial Sloan Kettering Cancer Center
CollaboratorOTHER
Istituto Clinico Humanitas
CollaboratorOTHER
Regina Elena Cancer Institute
CollaboratorOTHER
Baptist Health South Florida
CollaboratorOTHER
West Virginia University
CollaboratorOTHER
Scientific Institute San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach30-90 days after surgeryThe 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 approachfrom the surgery at 30-90 days afterThe 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 approach30-90 days after surgeryThe 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

MeasureTime frameDescription
Radicality of the resectionfrom 30 days after surgeryRadicality of the resection in the approaches
Duration of surgeryfrom 30 days after surgeryDuration of the surgery based on the approach measured in minutes
Survival analysisfrom 3 to 5 years after surgeryPresence or absence of local and distant relapse
Oncological treatmentfrom 30 days after surgeryResponse of the patient to oncological treatment
Quality of lymphadenectomyfrom 30 days after surgeryNumber of lymphonodes station resected
Conversion ratefrom 30 days after surgeryNumber of surgery procedures converted

Countries

Italy, United States

Contacts

Primary ContactPierluigi Novellis, Medical Doctor
novellis.pierluigi@hsr.it0226437202

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026