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

NCT ID: NCT06626243

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-10-15

Brief Summary

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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

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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.

Conditions

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Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Robotic Approach

Adult patients diagnosed with locally advanced and resectable non-small cell lung cancer (NSCLC) who underwent robotic lung resection

No interventions assigned to this group

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

No interventions assigned to this group

Open Approach

Adult patients diagnosed with locally advanced and resectable non-small cell lung cancer (NSCLC) who underwent open lung resection

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role collaborator

Regina Elena Cancer Institute

OTHER

Sponsor Role collaborator

Baptist Health South Florida

OTHER

Sponsor Role collaborator

West Virginia University

OTHER

Sponsor Role collaborator

Scientific Institute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Pierluigi Novellis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Baptist Health South Florida

Miami, Florida, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

West Virginia University

Morgantown, West Virginia, United States

Site Status RECRUITING

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Site Status RECRUITING

Scientific Institute Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Regina Elena National Cancer Institute

Rome, , Italy

Site Status RECRUITING

Countries

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United States Italy

Central Contacts

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Pierluigi Novellis, Medical Doctor

Role: CONTACT

0226437202 ext. +39

Facility Contacts

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Mark R. Dylewski, MD

Role: primary

Bernard J. Park, MD

Role: primary

Alper Toker, MD

Role: primary

Giuseppe Marulli, MD

Role: primary

Pierluigi Novellis, MD

Role: primary

0226437202 ext. +39

Filippo Gallina, MD

Role: primary

Other Identifiers

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CET 380-2024

Identifier Type: -

Identifier Source: org_study_id