Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT06038227
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2023-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lung cAncer Robotic Comparative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020775', 'term': 'Thoracic Surgery, Video-Assisted'}], 'ancestors': [{'id': 'D013906', 'term': 'Thoracoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D020535', 'term': 'Video-Assisted Surgery'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 512}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2023-09-07', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient reported Quality of Life 1', 'timeFrame': '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.\n\nFor 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.\n\nThe 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', 'timeFrame': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of conversions from pre-operative surgical plan', 'timeFrame': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Minimally invasive surgery', 'Robotics'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '35108265', 'type': 'BACKGROUND', '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': '35461558', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/35108265/', 'label': '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/', 'label': '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.'}]}, 'descriptionModule': {'briefSummary': 'To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.', 'detailedDescription': '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.\n\nThe 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient diagnosed with clinical stage IA1-2 non-small cell lung cancer at time of procedure\n* Patient scheduled to undergo minimally invasive surgery for NSCLC with either da Vinci robotic assisted surgery or VATs\n* Aged ≥ 18 years\n* Must be willing and able to comply with study requirements\n* Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form\n\nExclusion Criteria:\n\n* Patients with clinical stage IA3, II, III, and IV lung cancer\n* Patient receiving a lobectomy/segmentectomy as an emergency procedure\n* Patients receiving a lobectomy/segmentectomy for metastatic cancer\n* Patients scheduled to receive a bilobectomy or sleeve-lobectomy\n* Mental incapacity to understand or consent to study procedures\n* Anticipated difficulty for patient to comply with protocol requirements\n* Unable to comply with the follow up schedule\n* Pregnant or are planning to become pregnant during the study\n* Life expectancy \\< 12 months'}, 'identificationModule': {'nctId': 'NCT06038227', 'acronym': 'LARCS', 'briefTitle': 'Lung cAncer Robotic Comparative Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intuitive Surgical'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '1114332C'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Robotic Assisted Thoracic Surgery', 'description': 'Participants will undergo robotic assisted thoracic surgery (RATS) for segmentectomy or lobectomy.', 'interventionNames': ['Procedure: Robotic Assisted Thoracic Surgery']}, {'label': 'Video Assisted Thoracic Surgery', 'description': 'Participants will undergo video assisted thoracic surgery (VATS) for segmentectomy or lobectomy.', 'interventionNames': ['Procedure: Video Assisted Thoracic Surgery']}], 'interventions': [{'name': 'Robotic Assisted Thoracic Surgery', 'type': 'PROCEDURE', 'description': 'Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.', 'armGroupLabels': ['Robotic Assisted Thoracic Surgery']}, {'name': 'Video Assisted Thoracic Surgery', 'type': 'PROCEDURE', 'description': 'Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.', 'armGroupLabels': ['Video Assisted Thoracic Surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pascal-Alexandre THOMAS', 'role': 'CONTACT'}, {'name': 'Pascal-Alexandre Thomas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AP-HM', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Marc Baste', 'role': 'CONTACT'}, {'name': 'Jean-Marc Baste', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent Brouchet', 'role': 'CONTACT'}, {'name': 'Laurent Brouchet', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Eichhorn', 'role': 'CONTACT'}, {'name': 'Martin Eichhorn', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Thoraxklinik', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Regensburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Hans-Stefan Hofmann', 'role': 'CONTACT'}, {'name': 'Hans-Stefan Hofmann', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Krankenhaus Barmherzige Brüder', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'city': 'Pisa', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carmelina Cristina, Zirafa', 'role': 'CONTACT'}, {'name': 'Carmelina Cristina Zirafa', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Loerenskog', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Rune, Eggum', 'role': 'CONTACT'}, {'name': 'Rune Eggum', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Akershus University Hospital'}, {'city': 'Bristol', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Igor Saftic', 'role': 'CONTACT'}, {'name': 'Igor Saftic', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospitals Bristol and Weston NHS Foundation Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Coventry', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Luis Hernandez', 'role': 'CONTACT'}, {'name': 'Luis Hernandez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospitals Coventry and Warwickshire NHS Trust', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'SE1 9RT', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Tom Routledge', 'role': 'CONTACT'}, {'name': 'Tom Routledge', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Guy's and St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Steven Stamenkovic', 'role': 'CONTACT'}, {'name': 'Steven Stamenkovic', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St Bartholomew Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Marie Allouis', 'role': 'CONTACT', 'email': 'Marie.Allouis@intusurg.com', 'phone': '+33786480495'}, {'name': 'James Grainger', 'role': 'CONTACT', 'email': 'james.grainger@intusurg.com'}], 'overallOfficials': [{'name': 'Tom Routledge', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guy's St Thomas' NHS Foundation Trust, UK"}, {'name': 'Rune Eggum', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Akershus'}, {'name': 'Martin Eichhorn', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thoraxklinik Heidelberg, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intuitive Surgical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}