Lung cAncer Robotic Comparative Study

Lung Cancer Clinical Trial

— LARCS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06038227
• Other study ID #: 1114332C
• Status: Recruiting
• Start date: July 15, 2023
• Est. completion date: December 30, 2027

Study information

• Verified date: January 2024
• Source: Intuitive Surgical
• Contact: Varsha Gandhi
• Phone: +44 7717356095
• Email: varsha.gandhi[@]intusurg.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 512
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• Robotic Assisted Thoracic Surgery
Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.
• Video Assisted Thoracic Surgery
Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month post surgery
Primary	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.	1 month post surgery
Secondary	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.	immediately post operative

External 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.