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 635
OP 638
DO 10.1136/ijgc-2019-000273
VO 29
IS 3
A1 Salvo, Gloria
A1 Ramirez, Pedro T
A1 Leitao, Mario
A1 Cibula, David
A1 Fotopoulou, Christina
A1 Kucukmetin, Ali
A1 Rendon, Gabriel
A1 Perrotta, Myriam
A1 Ribeiro, Reitan
A1 Vieira, Marcelo
A1 Baiocchi, Glauco
A1 Falconer, Henrik
A1 Persson, Jan
A1 Wu, Xiaohua
A1 Căpilna, Mihai Emil
A1 Ioanid, Nicolae
A1 Mosgaard, Berit Jul
A1 Berlev, Igor
A1 Kaidarova, Dilyara
A1 Olawaiye, Alexander Babatunde
A1 Liu, Kaijiang
A1 Nobre, Silvana Pedra
A1 Kocian, Roman
A1 Saso, Srdjan
A1 Rundle, Stuart
A1 Noll, Florencia
A1 Tsunoda, Audrey Tieko
A1 Palsdottir, Kolbrun
A1 Li, Xiaoqi
A1 Ulrikh, Elena
A1 Hu, Zhijun
A1 Pareja, Rene
YR 2019
UL http://ijgc.bmj.com/content/29/3/635.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.