Lung cAncer Robotic Comparative Study
LARCS
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
1 other identifier
observational
512
5 countries
11
Brief Summary
To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2023
CompletedFirst Submitted
Initial submission to the registry
August 24, 2023
CompletedFirst Posted
Study publicly available on registry
September 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
July 28, 2025
April 1, 2025
4.5 years
August 24, 2023
July 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patient reported Quality of Life 1
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
Patient reported Quality of Life 2
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
Secondary Outcomes (1)
Number of conversions from pre-operative surgical plan
immediately post operative
Study Arms (2)
Robotic Assisted Thoracic Surgery
Participants will undergo robotic assisted thoracic surgery (RATS) for segmentectomy or lobectomy.
Video Assisted Thoracic Surgery
Participants will undergo video assisted thoracic surgery (VATS) for segmentectomy or lobectomy.
Interventions
Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.
Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
AP-HM
Marseille, France
CHU de Rouen
Rouen, France
CHU de Toulouse
Toulouse, France
Thoraxklinik
Heidelberg, Germany
Krankenhaus Barmherzige Brüder
Regensburg, Germany
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Akershus University Hospital
Loerenskog, Norway
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
St Bartholomew Hospital
London, United Kingdom
Related Publications (2)
Patel YS, Hanna WC, Fahim C, Shargall Y, Waddell TK, Yasufuku K, Machuca TN, Pipkin M, Baste JM, Xie F, Shiwcharan A, Foster G, Thabane L. RAVAL trial: Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer. PLoS One. 2022 Feb 2;17(2):e0261767. doi: 10.1371/journal.pone.0261767. eCollection 2022.
PMID: 35108265BACKGROUNDSaji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022 Apr 23;399(10335):1607-1617. doi: 10.1016/S0140-6736(21)02333-3.
PMID: 35461558BACKGROUND
Related Links
- Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer
- Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tom Routledge
Guy's St Thomas' NHS Foundation Trust, UK
- PRINCIPAL INVESTIGATOR
Rune Eggum
University Hospital, Akershus
- PRINCIPAL INVESTIGATOR
Martin Eichhorn
Thoraxklinik Heidelberg, Germany
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2023
First Posted
September 14, 2023
Study Start
July 15, 2023
Primary Completion (Estimated)
December 30, 2027
Study Completion (Estimated)
December 30, 2027
Last Updated
July 28, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share