What is being investigated in this study?

This study investigates whether removal of the lymph nodes in the pelvis and alongside the abdominal aorta improves overall survival in women with uterine cancer at high risk of recurrence.

What is the aim of the study?

The study aims to clarify whether the previously standard removal of the lymph nodes in the pelvis and along the abdominal aorta in women with uterine cancer at high risk of recurrence improves the chances of cure (overall survival). If this is the case, this operation should continue to be recommended; if not, it should be omitted in the future.

What is the study procedure?

The study is being conducted nationwide in Germany at around 55 centers, and a total of 640 patients are to be included. This is a clinical study in which patients undergo surgery and are then followed up for 5 years.

It is a prospective, randomized, two-arm, multicenter, open-label study.

Eligible patients are randomly assigned to either receive the previously standard lymph node removal or to forgo it. For all patients, given the high risk of recurrence, vaginal radiotherapy (brachytherapy) and chemotherapy (carboplatin/paclitaxel) are recommended as adjuvant treatment after surgery.

Are there any risks?

You will be informed about possible risks and/or side effects associated with participation as part of an informed-consent discussion.

Eligibility requirements:

Women aged 18–75 years can participate in this study if the following criteria are met:

Excerpt from the inclusion criteria:

• Histologically confirmed endometrial cancer, clinical stage I or II, high risk of recurrence
  No previous surgery for endometrial cancer
• or surgery after hysterectomy (surgical removal of the uterus) within 8 weeks if no LNE has yet been performed
• No enlarged lymph nodes
  ECOG performance status 0–1

Excerpt from the exclusion criteria:

• Recurrence of endometrial cancer
• Sarcomas
• FIGO stage III or IV
• Previous chemo-, radio-, or endocrine therapy for endometrial cancer

In addition, there are further criteria that must be met to participate in the study. Interested patients should speak with a study physician at a study center, who can assess whether you are eligible for this study.

This study investigates whether removal of the lymph nodes in the pelvis and alongside the abdominal aorta improves overall survival in women with uterine cancer at high risk of recurrence.