TY - JOUR T1 - Robot-assisted approach to cervical cancer (RACC): an international multi-center, open-label randomized controlled trial JF - International Journal of Gynecologic Cancer JO - Int J Gynecol Cancer SP - 1072 LP - 1076 DO - 10.1136/ijgc-2019-000558 VL - 29 IS - 6 AU - Henrik Falconer AU - Kolbrun Palsdottir AU - Karin Stalberg AU - Pernilla Dahm-Kähler AU - Ulrika Ottander AU - Evelyn Serreyn Lundin AU - Lena Wijk AU - Rainer Kimmig AU - Pernille Tine Jensen AU - Ane Gerda Zahl Eriksson AU - Johanna Mäenpää AU - Jan Persson AU - Sahar Salehi Y1 - 2019/07/01 UR - http://ijgc.bmj.com/content/29/6/1072.abstract N2 - Background Radical hysterectomy with pelvic lymphadenectomy represents the standard treatment for early-stage cervical cancer. Results from a recent randomized controlled trial demonstrate that minimally invasive surgery is inferior to laparotomy with regards to disease-free and overall survival.Primary Objective To investigate the oncologic safety of robot-assisted surgery for early-stage cervical cancer as compared with standard laparotomy.Study Hypothesis Robot-assisted laparoscopic radical hysterectomy is non-inferior to laparotomy in regards to recurrence-free survival with the advantage of fewer post-operative complications and superior patient-reported outcomes.Trial Design Prospective, multi-institutional, international, open-label randomized clinical trial. Consecutive women with early-stage cervical cancer will be assessed for eligibility and subsequently randomized 1:1 to either robot-assisted laparoscopic surgery or laparotomy. Institutional review board approval will be required from all participating institutions. The trial is coordinated from Karolinska University Hospital, Sweden.Major Inclusion/Exclusion Criteria Women over 18 with cervical cancer FIGO (2018) stages IB1, IB2, and IIA1 squamous, adenocarcinoma, or adenosquamous will be included. Women are not eligible if they have evidence of metastatic disease, serious co-morbidity, or a secondary invasive neoplasm in the past 5 years.Primary Endpoint Recurrence-free survival at 5 years between women who underwent robot-assisted laparoscopic surgery versus laparotomy for early-stage cervical cancer.Sample Size The clinical non-inferiority margin in this study is defined as a 5-year recurrence-free survival not worsened by >7.5%. With an expected recurrence-free survival of 85%, the study needs to observe 127 events with a one-sided level of significance (α) of 5% and a power (1−β) of 80%. With 5 years of recruitment and 3 years of follow-up, the necessary number of events will be reached if the study can recruit a total of 768 patients.Estimated Dates for Completing Accrual and Presenting Results Trial launch is estimated to be May 2019 and the trial is estimated to close in May 2027 with presentation of data shortly thereafter.Trial Registration The trial is registered at ClinicalTrials.gov (NCT03719547). ER -