Summary
Endometrial cancer (EC) is the most common cancer affecting the female reproductive system. Treatment usually involves surgery to remove the uterus and to determine the extent of the disease (removal of fallopian tubes, ovaries and if required nearby lymph nodes) - called surgical staging.
Removing lymph nodes (called lymph node dissection) can help guide decisions about further treatment, like chemotherapy and radiation therapy. However, it can also lead to side effects such as swelling in the legs (lymphoedema). A newer technique called sentinel node biopsy (SNB) targets only the first lymph node(s) likely to be affected by cancer. This may reduce side effects, but it's not yet clear how SNB compares to not removing any lymph nodes at all.
About this study
This study aims to find out how helpful SNB is for patients and the healthcare system, and to make sure it doesn't cause harm.
Eligible participants will be randomly assigned to one of two treatment groups:
- Experimental Group: Surgery will include removal of the uterus, fallopian tubes, and ovaries (called TH-BSO), plus a sentinel node biopsy. A dye is injected near the tumour to help locate the first lymph node(s) that may be affected. These nodes are then removed and tested.
- Active Comparator Group: Surgery will include removal of the uterus, fallopian tubes, and ovaries (TH-BSO), without removing any lymph nodes.
In both groups, if participants are 45 years or younger, have Grade 1 endometrial adenocarcinoma (EAC) with myometrial invasion <50% and they wish to keep their ovaries, the ovary removal part of the procedure (BSO) may be skipped.