STATEC
Research type
Research Study
Full title
A randomised trial of non-Selective versus selective adjuvant Therapy in high risk Apparent sTage 1 Endometrial Cancer
IRAS ID
193891
Contact name
Lee Webber
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
STATEC investigates women with early stage cancer of the uterus (endometrial or womb cancer). It is assumed that the cancer is contained in the uterus. The basic treatment is removal of the uterus, tubes and ovaries (hysterectomy).
If cancer cells have spread outside the uterus, this surgical treatment is not sufficient. Chemotherapy and radiotherapy are required after surgery to try to eradicate the spread cancer cells. The difficulty is detecting whether cancer cells have escaped. Individual cells do not show up on scans, and cannot be seen at the time of surgery.
If the cancer in the uterus is aggressive, the risk of cells escaping rises to 20%. This situation is known as high risk apparent stage 1 disease ie the cancer is presumed to be confined to the uterus. The high risk refers to the 20% risk of cancer cells having escaped the uterus which would make the disease stage 3.
There are two approaches to treating high risk apparent stage 1 women, and it is not known which is the most effective in terms of the proportion of patients who survive. STATEC aims to find out which is the better treatment by comparing them in a randomised controlled design as follows:
Arm 1: In addition to hysterectomy, patients will have lymph glands (nodes) surgically removed (lymphadenectomy) to see if the cancer has spread to these glands. Patients without cancer in the lymph glands (node negative) will receive internal radiotherapy only, while patients with cancer found in the lymph glands (node positive) will receive chemotherapy and external radiotherapy.
Arm 2: Patients will have hysterectomy without lymphadenectomy, and all will be given chemotherapy and external radiotherapy.
The trial will recruit 2000 women from hospitals internationally. Patients will be followed up for 5 years.
REC name
London - Queen Square Research Ethics Committee
REC reference
16/LO/1979
Date of REC Opinion
15 Dec 2016
REC opinion
Further Information Favourable Opinion