RecruitingNAINTERVENTIONAL

A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

This research study is looking at two ways to treat early-stage cervical cancer: robotic-assisted keyhole surgery and traditional open surgery. Both involve removing the womb (hysterectomy) and checking lymph nodes for cancer. The main goal is to compare how well patients do after each type of surgery, specifically looking at how many remain cancer-free over time. Researchers want to find out if the robotic keyhole method is just as effective as the open surgery. This study is for women with certain types and stages of early cervical cancer. It's a way to help doctors understand the best surgical options for their patients.

At a glance

Status

Recruiting

Phase

Sponsor

GOG Foundation

Enrolment target

840

Start

22 Mar 2022

Estimated completion

01 Aug 2029

Cervical Cancer

What is this study about?

This study is designed to help us understand the best surgical options for women with early-stage cervical cancer. Doctors are comparing two main types of surgery: robotic-assisted 'keyhole' surgery (sometimes called 'da Vinci' surgery) and traditional open surgery. Both surgeries involve removing the womb (hysterectomy) and checking the nearby lymph nodes, which are small glands that are part of your immune system and can sometimes be where cancer spreads.

The main question this study wants to answer is whether the robotic-assisted keyhole surgery is just as good as open surgery in preventing the cancer from coming back. This is known as 'disease-free survival'. The 'keyhole' method uses smaller cuts and special instruments controlled by a surgeon via a robot, while open surgery involves a larger cut in the tummy area. Doctors need to find out if these different approaches lead to similar long-term results for patients.

During the surgery, doctors will carefully check for any signs of cancer spread. If cancer is found to have spread widely, the planned hysterectomy might not go ahead, and different treatment plans would be considered. This careful checking ensures that patients receive the most appropriate care based on what is found during the operation.

Key takeaways

Compares robotic keyhole surgery vs. open surgery for early cervical cancer.
Aims to see if both surgical methods are equally effective at preventing cancer recurrence.
Participants will be randomly assigned to one of the two surgery types.
Suitable for women with specific stages of early cervical cancer (FIGO IA2, IB1, IB2).
Participation involves careful monitoring and follow-up after surgery.

Who may be eligible?

To be part of this study, you would generally need to have a confirmed diagnosis of certain types of early cervical cancer. This means your cancer is at a stage known as FIGO Stage IA2, IBI, or IB2 (based on 2018 staging guidelines) and doesn't show signs of having spread to certain areas like nearby tissues or other parts of the body. Your tumour also needs to be 4 cm or less in size, as confirmed by an MRI scan.

You should be at least 18 years old and generally well enough to have major surgery, with a good overall health status. There are also specific measurements for the size of your womb and your tumour that need to be met. If you meet certain criteria, a simpler type of hysterectomy might be considered.

However, you wouldn't be able to join if you have other rare types of cervical cancer, or if your cancer is at a very early stage (1A1) or a more advanced stage (IB3, II-IV). We also ask that you are able to give your informed consent, which means understanding the study and agreeing 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.

Do you have certain types of early cervical cancer, specifically adenocarcinoma or squamous cell carcinoma?
Is your cancer stage FIGO IA2, IB1, or IB2 and hasn't spread elsewhere?
Is your tumour 4 cm or less, as confirmed by an MRI scan?
Are you 18 years or older and considered healthy enough for major surgery?
Do you understand and agree to the random assignment to either robotic or open surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the robotic-assisted keyhole surgery or the open surgery. This is like flipping a coin to decide which group you're in. During the operation, the surgical team will follow specific steps, including carefully checking for any cancer spread and making detailed notes about the surgery, such as how long it took and any complications. For those having robotic surgery, they'll also note specific details about the equipment used.

After your surgery, the research team will follow your health over time to see how you recover and if the cancer stays away. This involves regular check-ups and possibly scans, similar to what you would have as part of your standard cancer care. The total duration of your participation in the study, including follow-up, would be discussed with you in detail by your healthcare team.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is contributing to valuable knowledge that could improve future treatments for cervical cancer. You will receive very careful monitoring and standard surgical care. However, as with any major surgery, there are risks involved, such as bleeding, infection, or other complications, and these will be carefully explained by your care team. There's also the chance that the treatment you receive may not be more effective than other available options. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (136)

Western Regional Medical Center LLC
Verified postcode
Goodyear, United States· Recruiting
City of Hope
Verified postcode
Duarte, United States· Recruiting
University of California San Diego Medical Center
Verified postcode
Encinitas, United States· Recruiting
City of Hope Orange County Lennar Foundation Cancer
Verified postcode
Irvine, United States· Recruiting
University of California San Diego Medical Center
Verified postcode
La Jolla, United States· Recruiting
University of California San Diego Moores Cancer Center
Verified postcode
La Jolla, United States· Recruiting
Hoag Gynecologic Oncology
Verified postcode
Newport Beach, United States· Recruiting
Hoag Memorial Hospital Presbyterian
Verified postcode
Newport Beach, United States· Recruiting
Palo Alto Medical Foundation
Verified postcode
Palo Alto, United States· Recruiting
Stanford Hospital
Verified postcode
Palo Alto, United States· Recruiting
University of California San Diego Medical Center
Verified postcode
San Diego, United States· Recruiting
California Pacific Medical Center-Research Institute
Verified postcode
San Francisco, United States· Recruiting

Common questions

What is 'robotic-assisted' surgery?

It's a type of keyhole surgery where the surgeon sits at a console and uses robotic arms to perform the operation through small cuts, offering precision and enhanced vision.

What does 'non-inferiority' mean in this study?

It means the study aims to show that robotic surgery is 'not worse' than open surgery in terms of how well patients do after treatment, not necessarily that it's better.

What is a hysterectomy?

A hysterectomy is a surgical operation to remove the womb (uterus). In this study, it's done to treat cervical cancer.

Will I get to choose which surgery I have?

No, if you join the study, you'll be randomly assigned to either the robotic or open surgery group, like flipping a coin. This helps make the study fair.

What happens if cancer is found to have spread during surgery?

If significant cancer spread is found, the planned hysterectomy might not go ahead, and your doctors would discuss alternative treatment plans with you.

How to find out more

Jennifer Klein, MEd

jklein@gog.org 215-854-0770 Official trial record

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