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Trial Details
Trial status:
Recruitment suspended
Recruitment start date:
12/04/2017
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Mr Tim Mould
Recruitment target:
1720
EudraCT number:
N/A
Contact details:
ctc.STATEC@ucl.ac.uk
Lay summary:
STATEC
A randomised trial of non-Selective versus selective adjuvant Therapy in high risk Apparent sTage 1 Endometrial Cancer
Description
Design: STATEC is a randomised (1:1) multicentre international phase III trial of hysterectomy with lymphadenectomy vs hysterectomy alone in women with high risk apparent stage I endometrial cancer.
Treatment: Patients are either randomised prior to surgery or within 28 days of hysterectomy. Arm 1 patients will undergo lymphadenectomy, with adjuvant treatment determined by lymph node status: chemotherapy +/- radiotherapy for node positive, vaginal brachytherapy for node negative. Arm 2 patients will all be given chemotherapy +/- radiotherapy following hysterectomy.   
Key inclusion/exclusion criteria:

Histologically confirmed high risk apparent FIGO stage I endometrial cancer.

Confirmation must be based on either a) diagnostic endometrial sampling or b) hysterectomy specimen if randomisation occurring after hysterectomy.

No prior anticancer therapy for endometrial cancer.

ECOG performance status 0-2.

Patients must be willing and able to complete quality of life questionnaires.  

Patients cannot have grossly enlarged nodes, invasion of the cervical stroma, involvement of uterine serosa or metastatic disease outside the uterus on baseline radiological imaging.

Duration of recruitment: 4 years.
Aim
To determine whether lymphadenectomy, used to restrict adjuvant therapy (other than vaginal brachytherapy) to node positive women, results in a non-inferior survival as compared to adjuvant therapy given to all women with high risk apparent stage I endometrial cancer.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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