Lung cAncer Robotic Comparative Study (LARCS)
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Details and patient eligibility
About
To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.
Full 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.
Enrollment
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Volunteers
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
Trial design
512 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
James Grainger; Marie Allouis
Data sourced from clinicaltrials.gov
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