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RecruitingNCT06626243IMMUNORATSUpdated Nov 29, 2024

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

An observational study in Non-Small Cell Lung Cancer, sponsored by Scientific Institute San Raffaele. Recruiting at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by Scientific Institute San Raffaele · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
140
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • Video-Assisted Thoracoscopic Surgery
  • Robot-Assisted Thoracoscopic Surgery
  • open approach
03

In context

Carcinoma, Non-Small-Cell Lung

7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.

This study's planned enrollment of 140 is below the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Scientific Institute San Raffaele is the lead sponsor of 29 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 chemo-immunotherapy or immunotherapy alone
  • Age >= 18 years old at the moment of surgery

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years old at the moment of surgery
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
140 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30-90 days after surgery

  2. 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.

    Time frame: from the surgery at 30-90 days after

  3. 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.

    Time frame: 30-90 days after surgery

Secondary outcomes

  1. Duration of surgery

    Duration of the surgery based on the approach measured in minutes

    Time frame: from 30 days after surgery

  2. Quality of lymphadenectomy

    Number of lymphonodes station resected

    Time frame: from 30 days after surgery

  3. Conversion rate

    Number of surgery procedures converted

    Time frame: from 30 days after surgery

  4. Radicality of the resection

    Radicality of the resection in the approaches

    Time frame: from 30 days after surgery

  5. Oncological treatment

    Response of the patient to oncological treatment

    Time frame: from 30 days after surgery

  6. Survival analysis

    Presence or absence of local and distant relapse

    Time frame: from 3 to 5 years after surgery

07

Study locations

6 of 6 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06626243
Lead sponsor
Scientific Institute San Raffaele
Collaborators
Memorial Sloan Kettering Cancer Center, Istituto Clinico Humanitas, Regina Elena Cancer Institute, Baptist Health South Florida, West Virginia University
Responsible party
Pierluigi Novellis (Principal Investigator, Scientific Institute San Raffaele) — Principal investigator
First posted
Oct 3, 2024
Start date
Sep 30, 2024
Primary completion
Feb 15, 2025 (estimated)
Completion
Oct 15, 2025 (estimated)
Last update
Nov 29, 2024

Study contacts

Pierluigi Novellis, Medical Doctor
Contact
novellis.pierluigi@hsr.it
0226437202 ext. +39

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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