RecruitingOBSERVATIONAL

European Collaborative Multicenter Observational Study: Modular Treatment With PMMR and Targeted Compartmental Pelvic Lymphadenectomy Followed by Therapeutic Pelvic and Paraaortic Lymphadenectomy in Node Positive Disease for Locoregional Control in Endometrial Cancer FIGO Stages I-III

This study is exploring a new surgical approach for womb cancer (endometrial cancer) that hasn't spread extensively, to see if it can prevent the cancer from returning to the original area. Some womb cancers, even those considered lower risk, can have small amounts of cancer in the lymph nodes nearby. While radiation can help stop it coming back, it doesn't improve survival and has side effects. This new surgery aims to remove the cancer more precisely to avoid these side effects and still achieve good results. Researchers will compare this new surgical method with the standard treatments currently used, looking at how well it stops the cancer from coming back and how long people stay cancer-free. The goal is to find a treatment that is both effective and has fewer side effects.

At a glance

Status

Recruiting

Sponsor

Dr. Paul Buderath

Enrolment target

500

Start

10 Oct 2017

Estimated completion

01 Jan 2030

Endometrial Cancer

What is this study about?

This study is about finding the best way to treat womb cancer, specifically when it's in earlier stages (FIGO Stages I-III) and hasn't spread widely. Sometimes, even with surgery, womb cancer can come back in the same area. Doctors usually give radiation treatment to try and stop this, but radiation can have strong side effects and hasn't been shown to help people live longer. This study wants to see if a newer, more precise type of surgery can prevent the cancer from returning without needing radiation, thus avoiding its side effects.

The new surgical method involves two main steps: first, a special surgery to remove the main tumour along with nearby lymph nodes that act as 'sentinels' (like guards) to see if the cancer has started to spread. If these sentinel nodes show that the cancer has spread, or if there's a higher risk of it spreading, then a second, more extensive lymph node surgery might be done. The idea is to remove all the 'at-risk' tissue that has developed from the same parts of the body during growth, making the surgery as complete as possible in those areas.

Researchers will compare people who have this new surgical approach (Cohort A) with people who receive the standard treatment for womb cancer (Cohort B), which follows current UK and European guidelines. They want to find out if the new surgery leads to fewer instances of cancer returning to the original area and if people live longer without the cancer coming back. The study will follow patients for five years after their first surgery to monitor their progress.

Key takeaways

This study evaluates a new surgical method for womb cancer.
It aims to prevent cancer recurrence without relying on radiation treatment.
Two treatment approaches will be compared: the new surgery vs. standard care.
The study focuses on earlier stages of womb cancer (Stages I-III).
You will be followed for 5 years to see the long-term results.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for women aged 18 or older who have been diagnosed with womb cancer (endometrial cancer) confirmed by a biopsy. Your general health should be good enough for surgery, meaning you can do most of your daily activities without much difficulty. You must also agree to take part and provide your consent.

There are also some reasons why you might not be able to join. For example, if you have a different type of womb cancer called uterine sarcoma, or if your cancer has already spread to distant parts of your body. You also can't join if you've had radiation treatment to your pelvis before, or if you are pregnant. Certain conditions like lupus are also excluded because they might affect how you recover from surgery.

Importantly, if you choose the new surgical treatment in this study, you generally won't receive radiation therapy afterwards, unless there are very specific reasons (like some cancer cells left behind or many lymph nodes involved). However, chemotherapy might still be offered if your cancer is considered higher risk. If you prefer to have the standard treatment with radiation as often done, you could still be part of the comparison group.

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.

I am 18 years old or older.
I have been diagnosed with womb cancer (endometrial cancer).
My cancer is in stages I, II, or III.
I am generally well enough to have surgery.
I have not previously had radiation treatment to my pelvis.
I do not have distant cancer spread or certain other medical conditions.

Answer every question to see your result.

What does participation involve?

If you join this study, your treatment will either follow a new surgical plan or the standard care. If you're in the new surgery group, you'll have specific operations as described, and typically won't have radiation afterwards, though chemotherapy might be offered for higher-risk cancers. If you're in the standard care group, your treatment will follow usual guidelines, which may include radiation.

Regardless of your group, you'll have regular check-ups and follow-up appointments after your surgery. These appointments are important for the doctors to monitor your recovery and track whether the cancer returns. The study plans to follow everyone for five years from the date of their first surgery to see how well each treatment works over the long term. Beyond your treatments, there won't be extra visits or assessments solely for the study; your follow-up will be part of your ongoing medical care.

Potential risks and benefits

Potential benefits of participating could include receiving a new, potentially more focused surgical treatment that aims to avoid the side effects of traditional radiation therapy, while still effectively controlling your cancer. For those in the standard care group, your treatment will be planned according to well-established guidelines. All surgeries carry risks, such as infection, bleeding, or issues with healing. You will be fully informed about the specific risks of any recommended procedure. You have the right to withdraw from the study at any time without affecting your future medical care.

Locations (1)

University Hospital Essen, Department of Gynaecology
Verified postcode
Essen, Germany· Recruiting

Common questions

What is womb cancer?

Womb cancer, also called endometrial cancer, is a type of cancer that starts in the lining of the womb (uterus).

What are lymph nodes and why are they important?

Lymph nodes are small, bean-shaped glands that are part of your immune system. They help filter harmful substances. In cancer, they are important because cancer cells can sometimes spread through them.

What does "locoregional recurrence" mean?

This means the cancer has come back in the same area where it first started, or in nearby tissues or lymph nodes.

Will I have to pay to participate in this study?

No, you will not have to pay to participate in this study. All treatments and assessments related to the study will be covered.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without needing to give a reason, and it will not affect your future medical care.

How to find out more

Paul Buderath, Dr.

paul.buderath@uk-essen.de +492017232442 Official trial record

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