Non-Small Cell Lung CancerIMMUNORATSNCT06626243
Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy in Patients Performed in Five Referred Centers
An observational study of Non-Small Cell Lung Cancer, run by Scientific Institute San Raffaele at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 140 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 30 Sep 2024to 15 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age <18 years old at the moment of surgery
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Baptist Health South Florida
Miami, Florida, 33176
Mark R. Dylewski, MD, MarkD@baptisthealth.net
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
Alper Toker, MD, alper.toker@wvumedicine.org
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Bernard J. Park, MD, parkb@mskcc.org
Italy3 sites, 3 recruiting
- Recruiting
Scientific Institute Ospedale San Raffaele
Milan, 20132
Pierluigi Novellis, MD, 0226437202 ext. +39, novellis.pierluigi@hsr.it
- Recruiting
Regina Elena National Cancer Institute
Rome, 00144
Filippo Gallina, MD, filippo.gallina@ifo.it
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milan, 20089
Giuseppe Marulli, MD, giuseppe.marulli@humanitas.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Video-Assisted Thoracoscopic Surgery, Robot-Assisted Thoracoscopic Surgery, open approach
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach
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.
Measured: 30-90 days after surgery
The perioperative complications of robotic approach
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.
Measured: from the surgery at 30-90 days after
The perioperative complications of the open approach
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.
Measured: 30-90 days after surgery
Secondary outcomes (6)
Duration of surgery
Duration of the surgery based on the approach measured in minutes
Measured: from 30 days after surgery
Quality of lymphadenectomy
Number of lymphonodes station resected
Measured: from 30 days after surgery
Conversion rate
Number of surgery procedures converted
Measured: from 30 days after surgery
Radicality of the resection
Radicality of the resection in the approaches
Measured: from 30 days after surgery
Oncological treatment
Response of the patient to oncological treatment
Measured: from 30 days after surgery
Survival analysis
Presence or absence of local and distant relapse
Measured: from 3 to 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start30 Sep 2024
- Primary completion15 Feb 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scientific Institute San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, Istituto Clinico Humanitas, Regina Elena Cancer Institute, Baptist Health South Florida, West Virginia University
- Responsible party
- Principal investigator, Pierluigi Novellis, Scientific Institute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626243
- Sponsor's protocol ID
- CET 380-2024
- Acronym
- IMMUNORATS
- Status last verified
- Nov 2024
- First submitted
- 1 Oct 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Multicenter Retrospective Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy
- ClinicalTrials.gov ID
- NCT06626243
- Acronym / sponsor ID
- IMMUNORATS / CET 380-2024
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Video-Assisted Thoracoscopic Surgery, Robot-Assisted Thoracoscopic Surgery, open approach
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Scientific Institute San RaffaeleUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, Istituto Clinico Humanitas, Regina Elena Cancer Institute, Baptist Health South Florida, West Virginia University
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Age <18 years old at the moment of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Scientific Institute San Raffaele at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierluigi Novellis, Medical Doctor (0226437202 ext. +39, novellis.pierluigi@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach (time frame: 30-90 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.