Lung cAncer Robotic Comparative Study

Last updated: April 11, 2025
Sponsor: Intuitive Surgical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Cancer

Non-small Cell Lung Cancer

Lung Disease

Treatment

Robotic Assisted Thoracic Surgery

Video Assisted Thoracic Surgery

Clinical Study ID

NCT06038227
1114332C
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient diagnosed with clinical stage IA1-2 non-small cell lung cancer at time ofprocedure

  • Patient scheduled to undergo minimally invasive surgery for NSCLC with either daVinci 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 bysigning an appropriate informed consent form

Exclusion

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 Design

Total Participants: 512
Treatment Group(s): 2
Primary Treatment: Robotic Assisted Thoracic Surgery
Phase:
Study Start date:
July 15, 2023
Estimated Completion Date:
December 30, 2027

Study 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.

Connect with a study center

  • AP-HM

    Marseille,
    France

    Site Not Available

  • CHU de Rouen

    Rouen,
    France

    Active - Recruiting

  • CHU de Toulouse

    Toulouse,
    France

    Active - Recruiting

  • Thoraxklinik

    Heidelberg,
    Germany

    Active - Recruiting

  • Krankenhaus Barmherzige Brüder

    Regensburg,
    Germany

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa,
    Italy

    Active - Recruiting

  • Akershus University Hospital

    Loerenskog,
    Norway

    Active - Recruiting

  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol,
    United Kingdom

    Active - Recruiting

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • St Bartholomew Hospital

    London,
    United Kingdom

    Active - Recruiting

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