Lung CancerLARCSNCT06038227
Lung cAncer Robotic Comparative Study
An observational study of Lung Cancer, run by Intuitive Surgical at 13 sites in 7 countries.
Trial summary
To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Robotic Assisted Thoracic Surgery and Video Assisted Thoracic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 15 Jul 2023to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Unable to comply with the follow up schedule
- Pregnant or are planning to become pregnant during the study
- Life expectancy < 12 months
Trial locations and contacts
13 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
James Grainger contact
13 sites in 7 countries
United Kingdom4 sites, 4 recruiting
- Recruiting
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol
Igor Saftic
Igor Saftic
- Recruiting
University Hospitals Coventry and Warwickshire NHS Trust
Coventry
Luis Hernandez
Luis Hernandez
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Tom Routledge
Tom Routledge
- Recruiting
St Bartholomew Hospital
London
Steven Stamenkovic
Steven Stamenkovic
France3 sites, 3 recruiting
- Recruiting
AP-HM
Marseille
Pascal-Alexandre THOMAS
Pascal-Alexandre Thomas
- Recruiting
CHU de Rouen
Rouen
Jean Marc Baste
Jean-Marc Baste
- Recruiting
CHU de Toulouse
Toulouse
Laurent Brouchet
Laurent Brouchet
Germany2 sites, 2 recruiting
- Recruiting
Thoraxklinik
Heidelberg
Martin Eichhorn
Martin Eichhorn
- Recruiting
Krankenhaus Barmherzige Brüder
Regensburg
Hans-Stefan Hofmann
Hans-Stefan Hofmann
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital Rigshospitalet
Copenhagen
Rene Petersen
Rene Petersen
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa
Carmelina Cristina, Zirafa
Carmelina Cristina Zirafa
Norway1 site, 1 recruiting
- Recruiting
Akershus University Hospital
Loerenskog
Rune, Eggum
Rune Eggum
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich
Isabelle Schmitt-Opitz
Isabelle Schmitt-Opitz
About this study
Official 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
To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Robotic Assisted Thoracic Surgery, Video Assisted Thoracic Surgery
- Keywords
- Minimally invasive surgery, Robotics
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assisted Thoracic SurgeryProcedure or surgery
Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.
Video Assisted Thoracic SurgeryProcedure or surgery
Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Assisted Thoracic Surgery | Participants will undergo robotic assisted thoracic surgery (RATS) for segmentectomy or lobectomy. Receives: Procedure: Robotic Assisted Thoracic Surgery | |
| Video Assisted Thoracic Surgery | Participants will undergo video assisted thoracic surgery (VATS) for segmentectomy or lobectomy. Receives: Procedure: Video Assisted Thoracic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month post surgery
Secondary outcomes (1)
Number of conversions from pre-operative surgical plan
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.
Measured: immediately post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start15 Jul 2023
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Routledge, Principal investigator, Guy's St Thomas' NHS Foundation Trust, UKRune Eggum, Principal investigator, University Hospital, AkershusMartin Eichhorn, Principal investigator, Thoraxklinik Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038227
- Sponsor's protocol ID
- 1114332C
- Acronym
- LARCS
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35108265Saji 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.
PubMed 35461558
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06038227
- Acronym / sponsor ID
- LARCS / 1114332C
- Conditions
- Lung Cancer
- Keywords
- Minimally invasive surgery, Robotics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Assisted Thoracic Surgery | – | Procedure: Robotic Assisted Thoracic SurgeryParticipants will undergo robotic assisted thoracic surgery (RATS) for segmentectomy or lobectomy. |
| Video Assisted Thoracic Surgery | – | Procedure: Video Assisted Thoracic SurgeryParticipants will undergo video assisted thoracic surgery (VATS) for segmentectomy or lobectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Assisted Thoracic SurgerySurgeons will pre-determine to perform a segmentectomy or lobectomy using RATS. | Procedure or surgery | Robotic Assisted Thoracic Surgery |
| Video Assisted Thoracic SurgerySurgeons will pre-determine to perform a segmentectomy or lobectomy using VATS. | Procedure or surgery | Video Assisted Thoracic Surgery |
Primary outcome
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.
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.
1 secondary outcome
Number of conversions from pre-operative surgical plan
Time frame: immediately post operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 35108265Patel 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.
- Background: PubMed 35461558Saji 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.
- Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancerLink provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Grainger contact
Tom Routledge principal investigator
Guy's St Thomas' NHS Foundation Trust, UK
Rune Eggum principal investigator
University Hospital, Akershus
Martin Eichhorn principal investigator
Thoraxklinik Heidelberg, Germany
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Intuitive Surgical at 13 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom, France, Germany, Denmark, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Allouis (+33786480495, Marie.Allouis@intusurg.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported Quality of Life 1 (time frame: 1 month post surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06038227, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.