STATEC: A randomised trial of non-selective versus selective adjuvant therapy in high risk apparent stage 1 endometrial cancer.

Authors

null

Tim Mould

University College London Hospital, London, United Kingdom

Tim Mould , Alison Brand , Hans Nijman , Jonathan A. Ledermann , Richard J Edmondson , Jeremy Twigg , Emma Hudson , Carien L. Creutzberg , Naveena Singh , Raji Ganesan , Amanda Feeney , Laura Farrelly , Laura Hughes , Allan Hackshaw , Abigail Sharp , Peey Sei Kok , Henry C. Kitchener

Organizations

University College London Hospital, London, United Kingdom, Department of Gynaecologic Oncology, Westmead Hospital, Sydney, Australia, University Medical Center Groningen, University of Groningen, Groningen, Netherlands, University College London Cancer Institute, London, United Kingdom, Manchester Academic Health Science Centre, St Mary's Hospital, Manchester, United Kingdom, Department of Gynaecological Oncology, James Cook University Hospital, Middlesborough, United Kingdom, Velindre Cancer Centre, Cardiff, United Kingdom, Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands, St Bartholomew's Hospital, London, United Kingdom, Birmingham Women's NHS Foundation Trust, Birmingham, United Kingdom, Cancer Research UK and UCL Cancer Trials Centre, London, United Kingdom, Medical Research Council Clinical Trials Unit at University College London, London, United Kingdom, l.hughes@ucl.ac.uk, London, Australia, Cancer Research UK & UCL Cancer Trials Centre, London, United Kingdom, NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, Australia, Institute of Cancer Sciences, University of Manchester, Manchester, United Kingdom

Research Funding

Other

Background: The benefit of lymphadenectomy on survival in stage 1 endometrial cancer remains uncertain. STATEC is a surgical trial designed to evaluate the use of nodal status after lymph node dissection to tailor adjuvant treatment in patients with high risk apparent stage I endometrial cancer. Methods: DESIGN: Randomised (1:1), controlled, two-arm, phase III, multicentre, international, non-inferiority trial. ELIGIBILITY: High risk apparent FIGO stage I endometrial cancer on diagnostic endometrial sampling OR hysterectomy. If randomisation occurs after hysterectomy and BSO: FIGO grade 3 endometrioid or mucinous carcinoma, high grade serous, clear cell, undifferentiated or dedifferentiated carcinoma or mixed cell adenocarcinoma or carcinosarcoma. STRATIFICATION: participating site, histology, lymphovascular space invasion, timing of hysterectomy and bilateral salpingo-oophorectomy (BSO). TREATMENT: Arm 1: Hysterectomy and BSO, plus intraoperative bilateral pelvic and para-aortic lymph node dissection + adjuvant therapy if node positive or stage III. Arm 2: Hysterectomy and BSO+ adjuvant therapy based on stage and uterine factors. ENDPOINTS: Overall survival (primary), disease-free, endometrial cancer-event free and endometrial cancer-specific survival, pelvic and extra-pelvic relapse-free survival, cost-effectiveness, surgical adverse events, quality of life and performance of sentinel lymph node assessment (secondary). QUALITY ASSURANCE: surgical specimen processing and microscopy to local specialist gynaecological oncology site pathologists, central pathology (10% of UK patients) and surgical imaging of all Arm 1 patients. Recruitment: 4 years, with 5 years follow up. STATISTICS: Using the exponential parameter of 0.0040, allowable hazard ratio of 1.272, a sample size of 2000 (500 deaths) will provide 85% power, and 5% two-sided statistical significance. With 80% power, the minimum sample size is 1720 patients (430 deaths). CURRENT ENROLMENT (as of February 2018): STATEC is open in the UK, Australia and New Zealand. 7 patients have been enrolled. STATEC is registered with. Clinical trial information: NCT02566811

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Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Uterine Cancer

Clinical Trial Registration Number

NCT02566811

Citation

J Clin Oncol 36, 2018 (suppl; abstr TPS5615)

DOI

10.1200/JCO.2018.36.15_suppl.TPS5615

Abstract #

TPS5615

Poster Bd #

334b

Abstract Disclosures