@article {Salvo635, author = {Gloria Salvo and Pedro T Ramirez and Mario Leitao and David Cibula and Christina Fotopoulou and Ali Kucukmetin and Gabriel Rendon and Myriam Perrotta and Reitan Ribeiro and Marcelo Vieira and Glauco Baiocchi and Henrik Falconer and Jan Persson and Xiaohua Wu and Mihai Emil C{\u a}pilna and Nicolae Ioanid and Berit Jul Mosgaard and Igor Berlev and Dilyara Kaidarova and Alexander Babatunde Olawaiye and Kaijiang Liu and Silvana Pedra Nobre and Roman Kocian and Srdjan Saso and Stuart Rundle and Florencia Noll and Audrey Tieko Tsunoda and Kolbrun Palsdottir and Xiaoqi Li and Elena Ulrikh and Zhijun Hu and Rene Pareja}, title = {International radical trachelectomy assessment: IRTA study}, volume = {29}, number = {3}, pages = {635--638}, year = {2019}, doi = {10.1136/ijgc-2019-000273}, publisher = {BMJ Specialist Journals}, abstract = {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.}, issn = {1048-891X}, URL = {https://ijgc.bmj.com/content/29/3/635}, eprint = {https://ijgc.bmj.com/content/29/3/635.full.pdf}, journal = {International Journal of Gynecologic Cancer} }