Lung cAncer Robotic Comparative Study

NCT ID: NCT06038227

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

512 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-15

Study Completion Date

2027-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Robotic Assisted Thoracic Surgery

Participants will undergo robotic assisted thoracic surgery (RATS) for segmentectomy or lobectomy.

Robotic Assisted Thoracic Surgery

Intervention Type PROCEDURE

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.

Video Assisted Thoracic Surgery

Intervention Type PROCEDURE

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

Interventions

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Robotic Assisted Thoracic Surgery

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

Intervention Type PROCEDURE

Video Assisted Thoracic Surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intuitive Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tom Routledge

Role: PRINCIPAL_INVESTIGATOR

Guy's St Thomas' NHS Foundation Trust, UK

Rune Eggum

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Martin Eichhorn

Role: PRINCIPAL_INVESTIGATOR

Thoraxklinik Heidelberg, Germany

Locations

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AP-HM

Marseille, , France

Site Status RECRUITING

CHU de Rouen

Rouen, , France

Site Status RECRUITING

CHU de Toulouse

Toulouse, , France

Site Status RECRUITING

Thoraxklinik

Heidelberg, , Germany

Site Status RECRUITING

Krankenhaus Barmherzige Brüder

Regensburg, , Germany

Site Status RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Site Status RECRUITING

Akershus University Hospital

Loerenskog, , Norway

Site Status RECRUITING

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, , United Kingdom

Site Status RECRUITING

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, , United Kingdom

Site Status RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

St Bartholomew Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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France Germany Italy Norway United Kingdom

Central Contacts

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Marie Allouis

Role: CONTACT

+33786480495

James Grainger

Role: CONTACT

Facility Contacts

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Pascal-Alexandre THOMAS

Role: primary

Jean Marc Baste

Role: primary

Laurent Brouchet

Role: primary

Martin Eichhorn

Role: primary

Hans-Stefan Hofmann

Role: primary

Carmelina Cristina, Zirafa

Role: primary

Rune, Eggum

Role: primary

Igor Saftic

Role: primary

Luis Hernandez

Role: primary

Tom Routledge

Role: primary

Steven Stamenkovic

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 35108265 (View on PubMed)

Saji 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.

Reference Type BACKGROUND
PMID: 35461558 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/35108265/

Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer

https://pubmed.ncbi.nlm.nih.gov/35461558/

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.

Other Identifiers

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1114332C

Identifier Type: -

Identifier Source: org_study_id

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