Lung cAncer Robotic Comparative Study (LARCS)

March 31, 2026 updated by: Intuitive Surgical

Comparing Outcomes for Minimally Invasive Techniques for Anatomic Lung Resection for Cancer - A Prospective, Comparative, Non-randomized, Open Label Post-market Observational Cohort Study Within Europe

To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Detection of lung cancer is occurring at increasingly earlier stages due to improved screening and the discovery of incidental nodules. Coinciding with this trend is recent data from two international randomized, control trials, RAVAL - (Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer) and, JCOG0802 (The Japan Clinical Oncology Group) that show oncologic outcomes from segmentectomy are equivalent to lobectomy for cancers ≤2 cm. However, segmentectomy is a more complex technical operation that may not be easily feasible using video assisted thoracic surgery (VATS) but could be facilitated by robotic-assisted thoracic surgery (RATS), allowing improved vision, precision and controlled anatomic dissection.

The LARCS study is designed to understand the perioperative outcomes of patients and identify the real-world selection process of either VATS and RATS segmentectomy and lobectomy for lung cancers ≤2 cm. It aims to generate evidence to support integration of patient-centered care using minimally invasive technology.

In addition, health related quality of life captured in the study will also provide valuable insight into time to recovery, determining burden of the disease, and guide future treatment strategy.

Study Type

Observational

Enrollment (Estimated)

512

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 Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Recruiting
        • Copenhagen University Hospital Rigshospitalet
        • Contact:
          • Rene Petersen
        • Principal Investigator:
          • Rene Petersen
  • France
      • Marseille, France
        • Recruiting
        • AP-HM
        • Contact:
          • Pascal-Alexandre THOMAS
        • Principal Investigator:
          • Pascal-Alexandre Thomas
      • Rouen, France
        • Recruiting
        • CHU de Rouen
        • Contact:
          • Jean Marc Baste
        • Principal Investigator:
          • Jean-Marc Baste
      • Toulouse, France
        • Recruiting
        • CHU de Toulouse
        • Contact:
          • Laurent Brouchet
        • Principal Investigator:
          • Laurent Brouchet
  • Germany
      • Heidelberg, Germany
        • Recruiting
        • Thoraxklinik
        • Contact:
          • Martin Eichhorn
        • Principal Investigator:
          • Martin Eichhorn
      • Regensburg, Germany
        • Recruiting
        • Krankenhaus Barmherzige Brüder
        • Contact:
          • Hans-Stefan Hofmann
        • Principal Investigator:
          • Hans-Stefan Hofmann
  • Italy
      • Pisa, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Contact:
          • Carmelina Cristina, Zirafa
        • Principal Investigator:
          • Carmelina Cristina Zirafa
  • Norway
      • Loerenskog, Norway
        • Recruiting
        • Akershus University Hospital
        • Contact:
          • Rune, Eggum
        • Principal Investigator:
          • Rune Eggum
  • United Kingdom
      • Bristol, United Kingdom
        • Recruiting
        • University Hospitals Bristol and Weston NHS Foundation Trust
        • Contact:
          • Igor Saftic
        • Principal Investigator:
          • Igor Saftic
      • Coventry, United Kingdom
        • Recruiting
        • University Hospitals Coventry and Warwickshire NHS Trust
        • Contact:
          • Luis Hernandez
        • Principal Investigator:
          • Luis Hernandez
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust
        • Contact:
          • Tom Routledge
        • Principal Investigator:
          • Tom Routledge
      • London, United Kingdom
        • Recruiting
        • St Bartholomew Hospital
        • Contact:
          • Steven Stamenkovic
        • Principal Investigator:
          • Steven Stamenkovic

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

Data from adult participants who have a lobectomy or segmentectomy for treatment of non small cell lung cancer (clinical stages IA1-2) will be collected.

Description

Inclusion Criteria:

  • Patient diagnosed with clinical stage IA1-2 non-small cell lung cancer at time of procedure
  • Patient scheduled to undergo minimally invasive surgery for NSCLC with either da Vinci robotic assisted surgery or VATs
  • Aged ≥ 18 years
  • Must be willing and able to comply with study requirements
  • Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form

Exclusion Criteria:

  • Patients with clinical stage IA3, II, III, and IV lung cancer
  • Patient receiving a lobectomy/segmentectomy as an emergency procedure
  • Patients receiving a lobectomy/segmentectomy for metastatic cancer
  • Patients scheduled to receive a bilobectomy or sleeve-lobectomy
  • Mental incapacity to understand or consent to study procedures
  • Anticipated difficulty for patient to comply with protocol requirements
  • Unable to comply with the follow up schedule
  • Pregnant or are planning to become pregnant during the study
  • Life expectancy < 12 months

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
Intervention / Treatment
Robotic Assisted Thoracic Surgery
Participants will undergo robotic assisted thoracic surgery (RATS) for segmentectomy or lobectomy.
Procedure: Robotic Assisted Thoracic Surgery
Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.
Video Assisted Thoracic Surgery
Participants will undergo video assisted thoracic surgery (VATS) for segmentectomy or lobectomy.
Procedure: Video Assisted Thoracic Surgery
Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported Quality of Life 2
Time Frame: 1 month post surgery
RNLI (Reintegration to Normal Living Index) The RNLI has 11 questions and is scored on a visual analogue scale (VAS). On one end: "does not describe my situation" (1 or minimal integration) and "fully describes my situation" (10 or complete integration). Individual item scores are summed to provide the total score. The higher the score, the better the patients perceived integration.
1 month post surgery
Patient reported Quality of Life 1
Time Frame: 1 month post surgery

EQ 5D 5L (European Quality of Life Five Dimension) The EQ-5D-5L is a validated and established generic Patient Reported Outcome (PRO) instrument that uses 6 questions to assess patients' quality of life. It includes a vertical EQ visual analog scale (EQ VAS, 0-100 points) and a descriptive EQ-5D-5L system. An algorithm is used to calculate the scores.

For the descriptive section of the scale, an index value of 1 represents the best possible health state, while an index value of <0 (variable) represents the worst possible health state.

The EQ VAS score is rated on a scale of 0-100 points. 0 points correspond to the worst possible health status, while 100 points correspond to the best possible health status.
1 month post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of conversions from pre-operative surgical plan
Time Frame: immediately post operative
Number of participants who undergo conversion surgery from the pre-operative surgical plan captured on the surgical decision making form. Conversion may be from segmentectomy to lobetomy, RATS or VATS to open surgery.
immediately post operative

Collaborators and Investigators

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

Sponsor

Intuitive Surgical

Investigators

  • Principal Investigator: Tom Routledge, Guy's St Thomas' NHS Foundation Trust, UK
  • Principal Investigator: Martin Eichhorn, Thoraxklinik Heidelberg, Germany
  • Principal Investigator: Rune Eggum, University Hospital, Akershus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

July 15, 2023

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1114332C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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