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NCT Number: NCT06626243

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Humanitas, Rozzano, Milan, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Duration of surgery

    Time frame: from 30 days after surgery

    Duration of the surgery based on the approach measured in minutes

  2. Quality of lymphadenectomy

    Time frame: from 30 days after surgery

    Number of lymphonodes station resected

  3. Conversion rate

    Time frame: from 30 days after surgery

    Number of surgery procedures converted

  4. Radicality of the resection

    Time frame: from 30 days after surgery

    Radicality of the resection in the approaches

  5. Oncological treatment

    Time frame: from 30 days after surgery

    Response of the patient to oncological treatment

  6. Survival analysis

    Time frame: from 3 to 5 years after surgery

    Presence or absence of local and distant relapse

Study contacts

Contact information is provided by the study sponsor or research team.

Pierluigi Novellis, Medical Doctor

CONTACT

[email protected]

0226437202 ext. +39

Sponsors and collaborators

Lead sponsor

Scientific Institute San Raffaele

Other

Collaborators

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

Registry information

Official study title

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

Acronym: IMMUNORATS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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