RT Journal Article
SR Electronic
T1 PORTEC-4a: international randomized trial of molecular profile-based adjuvant treatment for women with high-intermediate risk endometrial cancer
JF International Journal of Gynecologic Cancer
JO Int J Gynecol Cancer
FD BMJ Publishing Group Ltd
SP ijgc-2020-001929
DO 10.1136/ijgc-2020-001929
A1 Anne Sophie V M van den Heerik
A1 Nanda Horeweg
A1 Remi A Nout
A1 Ludy C H W Lutgens
A1 Elzbieta M van der Steen-Banasik
A1 G Henrike Westerveld
A1 Hetty A van den Berg
A1 Annerie Slot
A1 Friederike L A Koppe
A1 Stefan Kommoss
A1 Jan Willem M Mens
A1 Marlies E Nowee
A1 Stefan Bijmolt
A1 David Cibula
A1 Tanja C Stam
A1 Ina M Jurgenliemk-Schulz
A1 An Snyers
A1 Moritz Hamann
A1 Aleida G Zwanenburg
A1 Veronique L M A Coen
A1 Katrien Vandecasteele
A1 Charles Gillham
A1 Cyrus Chargari
A1 Karen W Verhoeven-Adema
A1 Hein Putter
A1 Wilbert B van den Hout
A1 Bastiaan G Wortman
A1 Hans W Nijman
A1 Tjalling Bosse
A1 Carien L Creutzberg
YR 2020
UL http://ijgc.bmj.com/content/early/2020/10/15/ijgc-2020-001929.abstract
AB Background Vaginal brachytherapy is currently recommended as adjuvant treatment in patients with high-intermediate risk endometrial cancer to maximize local control and has only mild side effects and no or limited impact on quality of life. However, there is still considerable overtreatment and also some undertreatment, which may be reduced by tailoring adjuvant treatment to the patients’ risk of recurrence based on molecular tumor characteristics.Primary objectives To compare the rates of vaginal recurrence in women with high-intermediate risk endometrial cancer, treated after surgery with molecular-integrated risk profile-based recommendations for either observation, vaginal brachytherapy or external pelvic beam radiotherapy or with standard adjuvant vaginal brachytherapyStudy hypothesis Adjuvant treatment based on a molecular-integrated risk profile provides similar local control and recurrence-free survival as current standard adjuvant brachytherapy in patients with high-intermediate risk endometrial cancer, while sparing many patients the morbidity of adjuvant treatment and reducing healthcare costs.Trial design A multicenter, international phase III randomized trial (2:1) of molecular-integrated risk profile-based adjuvant treatment (experimental arm) or adjuvant vaginal brachytherapy (standard arm).Major inclusion/exclusion criteria Women aged 18 years and over with a histological diagnosis of high-intermediate risk endometrioid endometrial cancer after total abdominal or laparoscopic hysterectomy and bilateral salpingo-oophorectomy. High-intermediate risk factors are defined as: (i) International Federation of Gynecology and Obstetrics stage IA (with invasion) and grade 3; (ii) stage IB grade 1 or 2 with age ≥60 and/or lymph-vascular space invasion; (iii) stage IB, grade 3 without lymph-vascular space invasion; or (iv) stage II (microscopic and grade 1).Endpoints The primary endpoint is vaginal recurrence. Secondary endpoints are recurrence-free and overall survival; pelvic and distant recurrence; 5-year vaginal control (including treatment for relapse); adverse events and patient-reported symptoms and quality of life; and endometrial cancer-related healthcare costs.Sample size 500 eligible and evaluable patients.Estimated dates for completing accrual and presenting results Estimated date for completing accrual will be late 2021. Estimated date for presentation of (first) results is expected in 2023.Trial registration The trial is registered at clinicaltrials.gov (NCT03469674) and ISRCTN (11659025).