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
Study Overview
Status
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: James Grainger
- Email: james.grainger@intusurg.com
Study Contact Backup
- Name: Marie Allouis
- Phone Number: +33786480495
- Email: Marie.Allouis@intusurg.com
Study Locations
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Copenhagen, Denmark
- Recruiting
- Copenhagen University Hospital Rigshospitalet
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Contact:
- Rene Petersen
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Principal Investigator:
- Rene Petersen
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Marseille, France
- Recruiting
- AP-HM
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Contact:
- Pascal-Alexandre THOMAS
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Principal Investigator:
- Pascal-Alexandre Thomas
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Rouen, France
- Recruiting
- CHU de Rouen
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Contact:
- Jean Marc Baste
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Principal Investigator:
- Jean-Marc Baste
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Toulouse, France
- Recruiting
- CHU de Toulouse
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Contact:
- Laurent Brouchet
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Principal Investigator:
- Laurent Brouchet
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Heidelberg, Germany
- Recruiting
- Thoraxklinik
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Contact:
- Martin Eichhorn
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Principal Investigator:
- Martin Eichhorn
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Regensburg, Germany
- Recruiting
- Krankenhaus Barmherzige Brüder
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Contact:
- Hans-Stefan Hofmann
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Principal Investigator:
- Hans-Stefan Hofmann
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Pisa, Italy
- Recruiting
- Azienda Ospedaliero Universitaria Pisana
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Contact:
- Carmelina Cristina, Zirafa
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Principal Investigator:
- Carmelina Cristina Zirafa
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Loerenskog, Norway
- Recruiting
- Akershus University Hospital
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Contact:
- Rune, Eggum
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Principal Investigator:
- Rune Eggum
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Bristol, United Kingdom
- Recruiting
- University Hospitals Bristol and Weston NHS Foundation Trust
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Contact:
- Igor Saftic
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Principal Investigator:
- Igor Saftic
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Coventry, United Kingdom
- Recruiting
- University Hospitals Coventry and Warwickshire NHS Trust
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Contact:
- Luis Hernandez
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Principal Investigator:
- Luis Hernandez
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London, United Kingdom, SE1 9RT
- Recruiting
- Guy's and St Thomas' NHS Foundation Trust
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Contact:
- Tom Routledge
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Principal Investigator:
- Tom Routledge
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London, United Kingdom
- Recruiting
- St Bartholomew Hospital
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Contact:
- Steven Stamenkovic
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Principal Investigator:
- Steven Stamenkovic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Robotic Assisted Thoracic Surgery
Participants will undergo robotic assisted thoracic surgery (RATS) for segmentectomy or lobectomy.
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Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.
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Video Assisted Thoracic Surgery
Participants will undergo video assisted thoracic surgery (VATS) for segmentectomy or lobectomy.
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Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient reported Quality of Life 2
Time Frame: 1 month post surgery
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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.
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1 month post surgery
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Patient reported Quality of Life 1
Time Frame: 1 month post surgery
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of conversions from pre-operative surgical plan
Time Frame: immediately post operative
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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.
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immediately post operative
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Collaborators and Investigators
Sponsor
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
General Publications
- 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.
- 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.
Helpful 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Minimally Invasive Surgical Procedures
- Diagnostic Techniques, Surgical
- Endoscopy
- Thoracic Surgical Procedures
- Thoracoscopy
- Video-Assisted Surgery
- Thoracic Surgery, Video-Assisted
Other Study ID Numbers
- 1114332C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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