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

November 26, 2024 updated by: Pierluigi Novellis, Scientific Institute San Raffaele

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • Scientific Institute Ospedale San Raffaele
        • Contact:
      • Rome, Italy, 00144
        • Recruiting
        • Regina Elena National Cancer Institute
        • Contact:
    • Milan
  • United States
    • Florida
      • Miami, Florida, United States, 33176
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
    • West Virginia
      • Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Robotic Approach
Adult patients diagnosed with locally advanced and resectable non-small cell lung cancer (NSCLC) who underwent robotic lung resection
video-assisted thoracoscopic surgery (VATS) Approach
Adult patients diagnosed with locally advanced and resectable non-small cell lung cancer (NSCLC) who underwent video-assisted thoracoscopic surgery (VATS) lung resection
Open Approach
Adult patients diagnosed with locally advanced and resectable non-small cell lung cancer (NSCLC) who underwent open lung resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach
Time Frame: 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.
30-90 days after surgery
The perioperative complications of robotic approach
Time Frame: 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.
from the surgery at 30-90 days after
The perioperative complications of the open approach
Time Frame: 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.
30-90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of surgery
Time Frame: from 30 days after surgery
Duration of the surgery based on the approach measured in minutes
from 30 days after surgery
Quality of lymphadenectomy
Time Frame: from 30 days after surgery
Number of lymphonodes station resected
from 30 days after surgery
Conversion rate
Time Frame: from 30 days after surgery
Number of surgery procedures converted
from 30 days after surgery
Radicality of the resection
Time Frame: from 30 days after surgery
Radicality of the resection in the approaches
from 30 days after surgery
Oncological treatment
Time Frame: from 30 days after surgery
Response of the patient to oncological treatment
from 30 days after surgery
Survival analysis
Time Frame: from 3 to 5 years after surgery
Presence or absence of local and distant relapse
from 3 to 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scientific Institute San Raffaele

Collaborators

Memorial Sloan Kettering Cancer Center
Baptist Health South Florida
Istituto Clinico Humanitas
West Virginia University
Regina Elena Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2024

Primary Completion (Estimated)

February 15, 2025

Study Completion (Estimated)

October 15, 2025

Study Registration Dates

First Submitted

October 1, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CET 380-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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