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NCT Number: NCT06038227

Lung cAncer Robotic Comparative Study

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

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Key information

Conditions

Lung Cancer 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

Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Robotic Assisted Thoracic Surgery

Procedure

Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.

Video Assisted Thoracic Surgery

Procedure

Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

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

James Grainger

CONTACT

[email protected]

Marie Allouis

CONTACT

[email protected]

+33786480495

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

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

Acronym: LARCS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 14, 2023
Registry last updated
Apr 6, 2026

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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