RecruitingNAINTERVENTIONAL

Endometrial Cancer Lymphadenectomy Trial

This clinical trial, called the Endometrial Cancer Lymphadenectomy Trial, is investigating the best surgical approach for women with early-stage womb cancer (Endometrial Cancer) that has a higher chance of coming back. Researchers want to find out if removing more lymph nodes during surgery improves a woman's overall survival compared to standard surgery. Up to 640 women will take part. Some will have the standard surgery to remove the womb and surrounding organs. Others will have the same standard surgery plus a more extensive removal of lymph nodes in the pelvis and around the main blood vessels. The study also looks at how these surgeries affect quality of life and any potential side effects. The goal is to improve treatment for women diagnosed with this type of cancer.

At a glance

Status

Recruiting

Phase

Sponsor

Philipps University Marburg

Enrolment target

640

Start

28 Mar 2018

Estimated completion

15 Feb 2029

Cancer of Endometrium Stage I Cancer of Endometrium Stage II

What is this study about?

When someone is diagnosed with womb cancer (also known as endometrial cancer), surgery is often the main treatment. Sometimes, doctors might also remove lymph nodes – these are small, bean-shaped glands that are part of the body's immune system and can sometimes be where cancer cells spread. This study is specifically looking at women who have early-stage womb cancer, but where there's a higher chance the cancer could return.

The main question the researchers want to answer is whether removing more lymph nodes (a procedure called systematic lymphadenectomy) during surgery helps women live longer. They will compare two groups of women: one group will have the standard operation, and the other will have the standard operation plus this additional lymph node removal. They will then track how well both groups do over time.

Beyond simply looking at survival rates, the study also aims to understand other important factors. For example, they will investigate how each type of surgery affects a woman's quality of life, any potential problems or side effects that might occur, and how long women stay free from cancer after treatment. This information will help doctors recommend the best possible treatment for women with womb cancer in the future.

Key takeaways

This study compares two surgical approaches for early-stage womb cancer with a higher risk of return.
It aims to see if removing more lymph nodes improves survival.
Participation involves being randomly assigned to standard surgery or standard surgery plus more extensive lymph node removal.
The study also looks at quality of life and potential side effects.
It's for women aged 18-75 with specific womb cancer types.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would need to have a specific type of womb cancer that has been confirmed by doctors. This means your cancer would be in early stages (stage I or II) but with certain features that suggest a higher risk of it returning. You couldn't have had surgery for this womb cancer before, or if you did, it must have been a very specific type of surgery within 8 weeks that didn't involve removing lymph nodes.

There are also some things that would mean you couldn't take part. For example, your cancer can't have spread widely or to distant parts of the body. You also wouldn't be able to join if you've already had treatments like chemotherapy or radiotherapy for this cancer. General health is also important; you shouldn't have other serious medical conditions that would make surgery risky, or be taking medications that might cause problems during an operation. You would need to be between 18 and 75 years old and be able to give your full consent to participate.

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 I have a confirmed diagnosis of womb cancer?
Is my womb cancer currently Stage I or Stage II with a higher risk mentioned by my doctor?
Am I between 18 and 75 years old?
Have I NOT had any surgery for this womb cancer, or only a specific type of hysterectomy without lymph node removal less than 8 weeks ago?
Do I currently feel well enough for surgery?
Have I NOT had other treatments like chemo or radiotherapy for this cancer?

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 one of two groups, like flipping a coin. One group will have the standard surgery for womb cancer, which involves removing your womb and ovaries. The other group will have the same standard surgery, plus a more extensive removal of lymph nodes from your pelvis and around your kidney area. The study will track your health and recovery after the surgery, and you will have follow-up appointments over time so the medical team can monitor your progress and see how you are doing. The total duration of your participation would involve the surgery and a period of monitoring afterwards to see the long-term effects of the treatment.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that it might help improve survival for women with your type of womb cancer, although we don't know for sure yet which approach is better. You would also receive very close monitoring and care. However, there are potential risks, such as those associated with any surgery, including infection, bleeding, or reactions to anaesthesia. The more extensive lymph node removal might also lead to certain side effects, like swelling in the legs (lymphedema), damage to nerves, or longer recovery times. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (61)

Ostalb-Klinikum Aalen, Frauenklinik
Verified postcode
Aalen, Germany· Recruiting
Klinikum St. Marien Amberg, Frauenklinik
Verified postcode
Amberg, Germany· Recruiting
Klinikum Ansbach, Klinikum Ansbach
Verified postcode
Ansbach, Germany· Recruiting
Universitätsklinikum Augsburg, Frauenklinik
Verified postcode
Augsburg, Germany· Recruiting
Hochtaunus-Kliniken gGmbH, Frauenklinik
Verified postcode
Bad Homburg, Germany· Recruiting
Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde
Verified postcode
Bamberg, Germany· Recruiting
SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik
Verified postcode
Berlin, Germany· Recruiting
Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
Verified postcode
Berlin, Germany· Recruiting
Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe
Verified postcode
Berlin, Germany· Recruiting
Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
Verified postcode
Berlin, Germany· Recruiting
Martin-Luther-Krankenhaus, Klinik für Gynäkologie und Geburtshilfe
Verified postcode
Berlin, Germany· Recruiting
Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. Frauenheilkunde
Verified postcode
Bonn, Germany· Recruiting

Common questions

What is 'lymphadenectomy'?

Lymphadenectomy is a medical term for the surgical removal of lymph nodes. In this study, it refers to removing lymph nodes from the pelvis and around major blood vessels.

Why is this study only for certain types of womb cancer?

The study focuses on specific types of early-stage womb cancer that doctors believe have a higher chance of returning, as these are the cases where removing more lymph nodes might be most beneficial.

Will I get to choose which surgery I have?

No, if you join the study, you'll be randomly assigned to one of the two surgery groups. This is like drawing lots or flipping a coin and helps ensure the study results are fair and unbiased.

What happens if I change my mind during the study?

You are free to leave the study at any time, for any reason, without it affecting your future medical care.

Will I need other treatments like chemotherapy or radiotherapy?

For this study, you cannot have had chemo, radiation, or hormone therapy for your womb cancer before joining. Any decisions about treatments after your surgery in the study would be discussed with your medical team based on your individual case.

How to find out more

Philipp Harter, Professor MD

p.harter@kem-med.com +49 (0) 201 174-34511 Official trial record

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