RT Journal Article SR Electronic T1 International radical trachelectomy assessment: IRTA study JF International Journal of Gynecologic Cancer JO Int J Gynecol Cancer FD BMJ Publishing Group Ltd SP ijgc-2019-000273 DO 10.1136/ijgc-2019-000273 A1 Gloria Salvo A1 Pedro T Ramirez A1 Mario Leitao A1 David Cibula A1 Christina Fotopoulou A1 Ali Kucukmetin A1 Gabriel Rendon A1 Myriam Perrotta A1 Reitan Ribeiro A1 Marcelo Vieira A1 Glauco Baiocchi A1 Henrik Falconer A1 Jan Persson A1 Xiaohua Wu A1 Mihai Emil Căpilna A1 Nicolae Ioanid A1 Berit Jul Mosgaard A1 Igor Berlev A1 Dilyara Kaidarova A1 Alexander Babatunde Olawaiye A1 Kaijiang Liu A1 Silvana Pedra Nobre A1 Roman Kocian A1 Srdjan Saso A1 Stuart Rundle A1 Florencia Noll A1 Audrey Tieko Tsunoda A1 Kolbrun Palsdottir A1 Xiaoqi Li A1 Elena Ulrikh A1 Zhijun Hu A1 Rene Pareja YR 2019 UL http://ijgc.bmj.com/content/early/2019/02/13/ijgc-2019-000273.abstract AB Background Radical trachelectomy is considered a viable option for fertility preservation in patients with low-risk, early-stage cervical cancer. Standard approaches include laparotomy or minimally invasive surgery when performing radical trachelectomy.Primary Objective To compare disease-free survival between patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive (laparoscopic or robotic) radical trachelectomy.Study Hypothesis We hypothesize that minimally invasive radical trachelectomy has similar oncologic outcomes to those of the open approach.Study Design This is a collaborative, multi-institutional, international, retrospective study. Patients who underwent a radical trachelectomy and lymphadenectomy between January 1, 2005 and December 31, 2017 will be included. Institutional review board approval will be required. Each institution will be provided access to a study-specific REDCap (Research Electronic Data Capture) database maintained by MD Anderson Cancer Center and will be responsible for entering patient data.Inclusion Criteria Patients with squamous, adenocarcinoma, or adenosquamous cervical cancer FIGO (2009) stages IA2 and IB1 (≤2 cm) will be included. Surgery performed by the open approach or minimally invasive approach (laparoscopy or robotics). Tumor size ≤2 cm, by physical examination, ultrasound, MRI, CT, or positron emission tomography (at least one should confirm a tumor size ≤2 cm). Centers must contribute at least 15 cases of radical trachelectomy (open, minimally invasive, or both).Exclusion Criteria Prior neoadjuvant chemotherapy or radiotherapy to the pelvis for cervical cancer at any time, prior lymphadenectomy, or pelvic retroperitoneal surgery, pregnant patients, aborted trachelectomy (intra-operative conversion to radical hysterectomy), or vaginal approach.Primary Endpoint The primary endpoint is disease-free survival measured as the time from surgery until recurrence or death due to disease. To evaluate the primary objective, we will compare disease-free survival among patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive radical trachelectomy.Sample Size An estimated 535 patients will be included; 256 open and 279 minimally invasive radical trachelectomy. Previous studies have shown that recurrence rates in the open group range from 3.8% to 7.6%. Assuming that the 4.5-year disease-free survival rate for patients who underwent open surgery is 95.0%, we have 80% power to detect a 0.44 HR using α level 0.10. This corresponds to an 89.0% disease-free survival rate at 4.5 years in the minimally invasive group.