PT  - JOURNAL ARTICLE
AU  - Gloria Salvo
AU  - Pedro T Ramirez
AU  - Mario Leitao
AU  - David Cibula
AU  - Christina Fotopoulou
AU  - Ali Kucukmetin
AU  - Gabriel Rendon
AU  - Myriam Perrotta
AU  - Reitan Ribeiro
AU  - Marcelo Vieira
AU  - Glauco Baiocchi
AU  - Henrik Falconer
AU  - Jan Persson
AU  - Xiaohua Wu
AU  - Mihai Emil Căpilna
AU  - Nicolae Ioanid
AU  - Berit Jul Mosgaard
AU  - Igor Berlev
AU  - Dilyara Kaidarova
AU  - Alexander Babatunde Olawaiye
AU  - Kaijiang Liu
AU  - Silvana Pedra Nobre
AU  - Roman Kocian
AU  - Srdjan Saso
AU  - Stuart Rundle
AU  - Florencia Noll
AU  - Audrey Tieko Tsunoda
AU  - Kolbrun Palsdottir
AU  - Xiaoqi Li
AU  - Elena Ulrikh
AU  - Zhijun Hu
AU  - Rene Pareja
TI  - International radical trachelectomy assessment: IRTA study
AID  - 10.1136/ijgc-2019-000273
DP  - 2019 Feb 13
TA  - International Journal of Gynecologic Cancer
PG  - ijgc-2019-000273
4099  - http://ijgc.bmj.com/content/early/2019/02/13/ijgc-2019-000273.short
4100  - http://ijgc.bmj.com/content/early/2019/02/13/ijgc-2019-000273.full
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.