xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06038227</url>
    </required_header>
    <id_info>
      <org_study_id>Agile Number</org_study_id>
      <nct_id>NCT06038227</nct_id>
    </id_info>
    <brief_title>Lung cAncer Robotic Comparative Study</brief_title>
    <acronym>LARCS</acronym>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Intuitive Surgical</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Intuitive Surgical</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        To compare outcomes of minimally invasive surgical techniques for the treatment of&#xD;
        early-stage non-small cell lung cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Detection of lung cancer is occurring at increasingly earlier stages due to improved&#xD;
        screening and the discovery of incidental nodules. Coinciding with this trend is recent data&#xD;
        from two international randomized, control trials, RAVAL - (Robotic Lobectomy vs.&#xD;
        Thoracoscopic Lobectomy for Early Stage Lung Cancer) and, JCOG0802 (The Japan Clinical&#xD;
        Oncology Group) that show oncologic outcomes from segmentectomy are equivalent to lobectomy&#xD;
        for cancers ≤2 cm. However, segmentectomy is a more complex technical operation that may not&#xD;
        be easily feasible using video assisted thoracic surgery (VATS) but could be facilitated by&#xD;
        robotic-assisted thoracic surgery (RATS), allowing improved vision, precision and controlled&#xD;
        anatomic dissection.&#xD;
  &#xD;
        The LARCS study is designed to understand the perioperative outcomes of patients and identify&#xD;
        the real-world selection process of either VATS and RATS segmentectomy and lobectomy for lung&#xD;
        cancers ≤2 cm. It aims to generate evidence to support integration of patient-centered care&#xD;
        using minimally invasive technology.&#xD;
  &#xD;
        In addition, health related quality of life captured in the study will also provide valuable&#xD;
        insight into time to recovery, determining burden of the disease, and guide future treatment&#xD;
        strategy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 15, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Patient reported Quality of Life 1</measure>
      <time_frame>1 month post surgery</time_frame>
      <description>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.&#xD;
  For the descriptive section of the scale, an index value of 1 represents the best possible health state, while an index value of &lt;0 (variable) represents the worst possible health state.&#xD;
  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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient reported Quality of Life 2</measure>
      <time_frame>1 month post surgery</time_frame>
      <description>RNLI (Reintegration to Normal Living Index) The RNLI has 11 questions and is scored on a visual analogue scale (VAS). On one end: &quot;does not describe my situation&quot; (1 or minimal integration) and &quot;fully describes my situation&quot; (10 or complete integration). Individual item scores are summed to provide the total score. The higher the score, the better the patients perceived integration.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of conversions from pre-operative surgical plan</measure>
      <time_frame>immediately post operative</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">512</enrollment>
    <condition>Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Robotic Assisted Thoracic Surgery</arm_group_label>
      <description>Participants will undergo robotic assisted thoracic surgery (RATS) for segmentectomy or lobectomy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Video Assisted Thoracic Surgery</arm_group_label>
      <description>Participants will undergo video assisted thoracic surgery (VATS) for segmentectomy or lobectomy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Robotic Assisted Thoracic Surgery</intervention_name>
      <description>Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.</description>
      <arm_group_label>Robotic Assisted Thoracic Surgery</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Video Assisted Thoracic Surgery</intervention_name>
      <description>Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.</description>
      <arm_group_label>Video Assisted Thoracic Surgery</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Data from adult participants who have a lobectomy or segmentectomy for treatment of non&#xD;
          small cell lung cancer (clinical stages IA1-2) will be collected.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient diagnosed with clinical stage IA1-2 non-small cell lung cancer at time of&#xD;
               procedure&#xD;
  &#xD;
            -  Patient scheduled to undergo minimally invasive surgery for NSCLC with either da Vinci&#xD;
               robotic assisted surgery or VATs&#xD;
  &#xD;
            -  Aged ≥ 18 years&#xD;
  &#xD;
            -  Must be willing and able to comply with study requirements&#xD;
  &#xD;
            -  Must indicate their understanding of the study and willingness to participate by&#xD;
               signing an appropriate informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with clinical stage IA3, II, III, and IV lung cancer&#xD;
  &#xD;
            -  Patient receiving a lobectomy/segmentectomy as an emergency procedure&#xD;
  &#xD;
            -  Patients receiving a lobectomy/segmentectomy for metastatic cancer&#xD;
  &#xD;
            -  Patients scheduled to receive a bilobectomy or sleeve-lobectomy&#xD;
  &#xD;
            -  Mental incapacity to understand or consent to study procedures&#xD;
  &#xD;
            -  Anticipated difficulty for patient to comply with protocol requirements&#xD;
  &#xD;
            -  Unable to comply with the follow up schedule&#xD;
  &#xD;
            -  Pregnant or are planning to become pregnant during the study&#xD;
  &#xD;
            -  Life expectancy &lt; 12 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tom Routledge</last_name>
      <role>Principal Investigator</role>
      <affiliation>Guy's St Thomas' NHS Foundation Trust, UK</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Rune Eggum</last_name>
      <role>Principal Investigator</role>
      <affiliation>Akershus University Hospital, Norway</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Martin Eichhorn</last_name>
      <role>Principal Investigator</role>
      <affiliation>Thoraxklinik Heidelberg, Germany</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Varsha Gandhi</last_name>
      <phone>+44 7717356095</phone>
      <email>varsha.gandhi@intusurg.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>James Grainger</last_name>
      <email>james.grainger@intusurg.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Guy's and St Thomas' NHS Foundation Trust</name>
        <address>
          <city>London</city>
          <zip>SE1 9RT</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tom Routledge</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/35108265/</url>
      <description>Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/35461558/</url>
      <description>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.</description>
    </link>
    <reference>
      <citation>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.</citation>
      <PMID>35108265</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>35461558</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Minimally invasive surgery</keyword>
    <keyword>Robotics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06038227
  org study id: Agile Number
  nct id: NCT06038227
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  To compare outcomes of minimally invasive surgical techniques for the treatment of
        early-stage non-small cell lung cancer.
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Patient reported Quality of Life 1
  time frame: 1 month post surgery
  description: 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.
  measure: Patient reported Quality of Life 2
  time frame: 1 month post surgery
  description: 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.
  measure: Number of conversions from pre-operative surgical plan
  time frame: immediately post operative
  description: 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.
  arm group label: Robotic Assisted Thoracic Surgery
  description: Participants will undergo robotic assisted thoracic surgery (RATS) for segmentectomy or lobectomy.
  arm group label: Video Assisted Thoracic Surgery
  description: Participants will undergo video assisted thoracic surgery (VATS) for segmentectomy or lobectomy.
  intervention type: Procedure
  intervention name: Robotic Assisted Thoracic Surgery
  description: Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.
  arm group label: Robotic Assisted Thoracic Surgery
  intervention type: Procedure
  intervention name: Video Assisted Thoracic Surgery
  description: Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.
  arm group label: Video Assisted Thoracic Surgery
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Tom Routledge
  role: Principal Investigator
  affiliation: Guy's St Thomas' NHS Foundation Trust, UK
  last name: Rune Eggum
  role: Principal Investigator
  affiliation: Akershus University Hospital, Norway
  last name: Martin Eichhorn
  role: Principal Investigator
  affiliation: Thoraxklinik Heidelberg, Germany
  last name: Varsha Gandhi
  phone: +44 7717356095
  email: varsha.gandhi@intusurg.com
  last name: James Grainger
  email: james.grainger@intusurg.com
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  url: https://pubmed.ncbi.nlm.nih.gov/35108265/
  description: Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer
  url: https://pubmed.ncbi.nlm.nih.gov/35461558/
  description: 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.
  citation: 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: 35108265
  citation: 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.
  PMID: 35461558
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  sharing ipd: No