International radical trachelectomy assessment: IRTA study

Abstract

BackgroundRadical 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 ObjectiveTo 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 HypothesisWe hypothesize that minimally invasive radical trachelectomy has similar oncologic outcomes to those of the open approach.Study DesignThis 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 CriteriaPatients 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 CriteriaPrior 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 EndpointThe 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 SizeAn 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.

Minimally invasive radical hysterectomy: an analysis of oncologic outcomes from Hospital Italiano (Argentina)

“…New investigations in progress will clarify some doubts about the tumor size,15 as well as, technical issues such as isolation of the vagina during colpotomy, or the combination of two surgical techniques, laparoscopic and vaginal, as potential strategies in the minimally invasive approach.…”

Minimally invasive versus open radical trachelectomy for early-stage cervical cancer: protocol for a multicenter randomized controlled trial in China

“… ► To our knowledge, this is the first multicenter RCT designed for the comparison of oncologic and fertility outcomes of different surgical routes of RT, despite a registered retrospective multicenter trial [ 22 ]. ► With the advantage of sufficient patients with early-stage CC in the study centers, this study can be implemented as soon as possible.…”

“…► To our knowledge, this is the first multicenter RCT designed for the comparison of oncologic and fertility outcomes of different surgical routes of RT, despite a registered retrospective multicenter trial [ 22 ].…”

Fertility-sparing Surgery for Patients with Cervical, Endometrial, and Ovarian Cancers

“…Robust outcomes data is currently limited for MIS radical trachelectomy; 8 the International Radical Trachelectomy Assessment (IRTA) study recently demonstrated no difference in disease-free survival or overall survival between open and MIS radical trachelectomy for FIGO 2009 stage 1A2 and 1B1. 14,15 However, recurrence was more common with MIS approaches if tumor size was >1cm or pre-operative CKC was not performed. 15 Survival outcomes are similar between vaginal and abdominal approaches, and recurrence radical trachelectomy is 2.0-5.8%, and.…”

“…14,15 However, recurrence was more common with MIS approaches if tumor size was >1cm or pre-operative CKC was not performed. 15 Survival outcomes are similar between vaginal and abdominal approaches, and recurrence radical trachelectomy is 2.0-5.8%, and. 16,17 For women with stage IB2 tumors, radical trachelectomy can be considered but should be performed via the abdominal approach in order to obtain wider parametrial margins.…”