RecruitingOBSERVATIONAL

Lung cAncer Robotic Comparative Study

This study, called LARCS, is looking at two types of keyhole surgery for people with early-stage lung cancer that's less than 2cm in size. These surgeries are Robotic-Assisted Thoracic Surgery (RATS) and Video-Assisted Thoracic Surgery (VATS). Both are less invasive than traditional open surgery. The main goal is to compare how well patients recover, their quality of life after surgery, and which method leads to better patient experiences. Researchers also want to understand why doctors choose one method over the other. The study will help improve future treatment plans by focusing on what's best for patients, using modern, less invasive surgical tools.

At a glance

Status

Recruiting

Sponsor

Intuitive Surgical

Enrolment target

512

Start

15 Jul 2023

Estimated completion

30 Dec 2027

Lung Cancer

What is this study about?

Imagine you have a very early stage of lung cancer, and your doctor suggests keyhole surgery to remove it. This study wants to understand which type of keyhole surgery works best for people like you. Specifically, it's comparing two main ways to do these operations: one uses very tiny cameras and tools, and the surgeon watches on a screen (this is called VATS), and the other uses a robot that the surgeon controls, which can offer even more control and a clearer view (this is called RATS).

The reason this study is important is that doctors are finding lung cancer much earlier now, thanks to better checks and scans. When cancer is found early and is small (less than 2cm), sometimes only a small part of the lung needs to be removed. Removing a smaller part of the lung, called a 'segmentectomy', can be trickier than removing a whole 'lobe' (a larger section of the lung). The study wants to see if robotic surgery (RATS) makes these trickier, smaller operations easier and more precise, perhaps leading to better results and faster recovery for patients.

Ultimately, researchers hope to gather information about how patients recover, how quickly they get back to their normal lives, and how their overall health and well-being are affected by these different surgeries. This will help doctors choose the best and most patient-friendly surgical approach for early lung cancer in the future, making sure your care is as good as it can be.

Key takeaways

Compares two keyhole surgeries for early lung cancer: robotic vs. video.
Aims to find out which surgery leads to better recovery and quality of life.
Focuses on small lung cancers (under 2cm).
Uses existing surgical procedures, no new treatments are given.
Helps improve future treatment choices for patients.
Participation involves sharing information about your surgery and recovery.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) who has been diagnosed with a very early stage of lung cancer (specifically, clinical stage IA1-2 non-small cell lung cancer) and are planning to have keyhole surgery for it. This surgery would either be robotic-assisted (RATS) or video-assisted (VATS). You'd also need to be willing to follow the study's instructions and understand what's involved by signing a consent form.

There are also some reasons why you wouldn't be able to join. For example, if your lung cancer is more advanced (stage IA3 or higher), or if you need emergency surgery. You also couldn't join if you're having surgery for cancer that has spread from another part of your body (metastatic cancer), or if you need a bigger, more complex lung operation than what this study is looking at.

Other reasons not to participate include if you're unable to understand or agree to the study, or if you might struggle to attend follow-up appointments. If you are pregnant, planning to become pregnant, or if doctors expect you to live for less than 12 months, you would also not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have very early-stage non-small cell lung cancer (stage IA1-2)?
Are you scheduled for keyhole surgery (VATS or RATS) for your lung cancer?
Are you willing to follow study instructions and attend follow-up appointments?
Are you not currently pregnant or planning to become pregnant during the study?
Is your expected lifespan more than 12 months?

Answer every question to see your result.

What does participation involve?

This section is not directly provided in the original text. However, a general participation explanation for a clinical trial would typically include: If you join this study, you would undergo either robotic-assisted or video-assisted keyhole surgery for your early-stage lung cancer, as planned by your medical team. The study would involve collecting information about your surgery, how you recover, and your general well-being for a period after the operation. This might include answering questionnaires about your quality of life, attending follow-up appointments as you normally would, and allowing researchers to review your medical records related to your lung cancer treatment. The total duration of your involvement would depend on the study's follow-up plan, although this is not specified here. There are no extra medications given as part of this study, as it's observing the outcomes of standard surgical procedures.

Potential risks and benefits

Taking part in this study could help doctors better understand the best way to treat early lung cancer, potentially improving care for future patients. You would receive one of two common types of keyhole surgery for lung cancer. There are no additional medical procedures or medications given specially for the study. However, as with any medical procedure, there are always some risks involved with surgery, such as infection or bleeding, which your surgeon would discuss with you. The study itself mainly involves collecting information about your recovery and quality of life. You are always free to change your mind and withdraw from the study at any time without it affecting your medical care.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Copenhagen University Hospital Rigshospitalet
Verified postcode
Copenhagen, Denmark· Recruiting
AP-HM
Verified postcode
Marseille, France· Recruiting
CHU de Rouen
Verified postcode
Rouen, France· Recruiting
CHU de Toulouse
Verified postcode
Toulouse, France· Recruiting
Thoraxklinik
Verified postcode
Heidelberg, Germany· Recruiting
Krankenhaus Barmherzige Brüder
Verified postcode
Regensburg, Germany· Recruiting
Azienda Ospedaliero Universitaria Pisana
Verified postcode
Pisa, Italy· Recruiting
Akershus University Hospital
Unverified
Loerenskog, Norway· Recruiting
University Hospitals Bristol and Weston NHS Foundation Trust
Verified postcode
Bristol, United Kingdom· Recruiting
University Hospitals Coventry and Warwickshire NHS Trust
Verified postcode
Coventry, United Kingdom· Recruiting
Guy's and St Thomas' NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
St Bartholomew Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'minimally invasive surgery'?

It means surgery done through very small cuts, often using cameras and special tools, instead of a large open cut. This usually leads to faster recovery.

What's the difference between robotic-assisted and video-assisted surgery?

Both are keyhole surgeries. Video-assisted (VATS) uses cameras and long tools. Robotic-assisted (RATS) also uses cameras but the surgeon controls a robot's arms, which can offer more precise movements and a magnified view.

Why is 'quality of life' important in this study?

Quality of life helps doctors understand how different surgeries affect your daily life, your energy levels, and how quickly you can get back to normal activities after treatment.

Will I have to pay to be part of this study?

No, you don't pay to be in a clinical study. Your regular medical treatment costs would be covered as normal by the NHS or your insurance, depending on your situation.

What if I decide I don't want to be in the study anymore?

You can leave the study at any time, for any reason, without it affecting your ongoing medical care or your relationship with your doctors.

How to find out more

Marie Allouis

Marie.Allouis@intusurg.com +33786480495 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.