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
In stage I endometrial cancer, the tumour appears to be confined to the uterus. Standard treatment is surgery to remove the uterus, fallopian tubes and ovaries. Approximately 85% of patients survive for at least 5 years.
However, 25% of newly diagnosed stage I cases are 'high risk', with potential to relapse and spread after surgery. Traditionally, high risk status has been confirmed by using scans and a tissue sample (biopsy) to look for features that cause the cancer to behave aggressively. The vast majority of high risk patients receive chemotherapy +/- radiotherapy after surgery.
The STATEC trial will compare this approach with an alternative treatment strategy: whether lymphadenectomy has an effective role to play in selecting treatment after surgery. Lymphadenectomy is the surgical removal of lymph glands (nodes) to determine whether cancer has spread there. STATEC will use lymphadenectomy to identify 'node negative' patients without cancer in their lymph nodes i.e. patients not requiring extensive further treatment. 'Node positive' patients will require chemotherapy +/- radiotherapy. This approach may achieve comparable outcomes (including survival) to giving chemotherapy +/- radiotherapy to all high risk patients, with the advantage that node negative patients are spared additional treatment and the side effects (adverse events) that come with it.
The STATEC trial will randomise 2000 high risk patients from hospitals in both the UK and other countries.
Arm 1: Patients will receive lymphadenectomy as part of surgery, with subsequent treatment dependent on whether the nodes are a) negative, meaning that vaginal brachytherapy (an internal radiotherapy) will be given or b) positive, meaning that treatment will be chemotherapy +/- radiotherapy. There is an optional sentinel lymph node sub-study within this arm.
Arm 2: Patients will not receive lymphadenectomy and all will be given chemotherapy +/- radiotherapy after surgery.
All patients will be followed up for 5 years.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/1671
Date of REC Opinion
29 Sep 2016
REC opinion
Unfavourable Opinion