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

Note: For enquiries only. DO NOT use for clinical referrals.

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.

Contact the trial team

View trial summary

View trial documents

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

CTC staff

University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000