Lung cAncer Robotic Comparative Study

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Patient reported Quality of Life 1 [Срок оценки: 1 month post surgery]
• Patient reported Quality of Life 2 [Срок оценки: 1 month post surgery]

Вторичные конечные точки (1)

• Number of conversions from pre-operative surgical plan [Срок оценки: immediately post operative]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 4 центра

• University Hospitals Bristol and Weston NHS Foundation Trust — Bristol
• University Hospitals Coventry and Warwickshire NHS Trust — Coventry
• Guy's and St Thomas' NHS Foundation Trust — London
• St Bartholomew Hospital — London

Франция · 3 центра

• AP-HM — Marseille
• CHU de Rouen — Rouen
• CHU de Toulouse — Toulouse

Германия · 2 центра

• Thoraxklinik — Heidelberg
• Krankenhaus Barmherzige Brüder — Regensburg

Дания · 1 центр

• Copenhagen University Hospital Rigshospitalet — Copenhagen

Италия · 1 центр

• Azienda Ospedaliero Universitaria Pisana — Pisa

Норвегия · 1 центр

• Akershus University Hospital — Loerenskog

Публикации

• 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. eColl PMID 35108265
• 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- PMID 35461558

Идентификаторы

NCT: NCT06038227 · 1114332C

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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