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.

1st Clinic of Obstetrics and Gynecology University of Medicine and Pharmacy of Târgu Mureş Târgu Mureş Romania

A C Camargo Cancer Center São Paulo Brazil

Copenhagen University Hospital Rigshospitalet Copenhagen Denmark

Department of Gynecologic Oncology and Reproductive Medicine University of Texas MD Anderson Cancer Center Houston Texas USA

Department of Gynecologic Oncology Imperial College London London UK

Fudan University Shanghai Cancer Center Shanghai China

General University Hospital Prague 1st Faculty of Medicine Charles University Prague Czech Republic

Ginecologia y Obstetricia Hospital Italiano de Buenos Aires Buenos Aires Argentina

Gynecologic Oncology UPMC Pittsburgh USA

Hospital de Cancer de Barretos Barretos Brazil

Hospital Erasto Gaertner Curitiba Brazil

Instituto de Cancerologia de las Americas Medellin Colombia

Instituto Nacional del Cancer Bogota Colombia

IOP Instituto de Oncologia do Parana Curitiba Brazil

Karolinska Institutet Stockholm Sweden

Kazahskij naucno issledovatel'skij institut onkologii i radiologii Almaty Kazakhstan

Memorial Sloan Kettering Cancer Center New York USA

North Western State Medical University N N Petrov Research Institute of Oncology Saint Petersburg Russian Federation

Oncological surgery Clinica Astorga Envigado Colombia

Queen Elizabeth Hospital Gateshead UK

RenJi Hospital affiliated to Shanghai Jiao Tong University School of Medicine Shanghai China

Skane University Hospital Scania Sweden

The Regional Institute of Oncology of Iasi Iasi Romania

Zobrazit více v PubMed

Parkin DM. Global cancer statistics in the year 2000. Lancet Oncol 2001;2:533–43. PubMed

F K. Patterns of cancer incidence, mortality and prevalence across five continents: defining priorities to predict cancer disparities in different geographic regions of the world. J Clin Oncol 2006;24:2137–50. PubMed

Cervical cancer: Estimated Incidence, Mortality and Prevalence Worldwide in 2012. International Agency for research on Cancer and World Health Organization; 2012. 2012.

Jemal A et al. Global cancer statistics. CA Cancer J Clin 2011;61:69–90. PubMed

National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology Cervical Cancer (version I.2018) 2018.

NIH. Cancer Stat Facts: Cervical Cancer n.d.

Dargent DMP. Schauta’s vaginal hysterectomy combined with laparoscopic lymphadenectomy. Gyn OncBaillieres Clin Obs Gynaecol 1995;9:691–705. PubMed

Plante M, Renaud M-C, Francois H, Roy M. Vaginal radical trachelectomy: an oncologically safe fertility-preserving surgery. An updated series of 72 cases and review of the literature. Gynecol Oncol 2004;94:614–23. PubMed

Beiner ME, Hauspy J, Rosen B, Murphy J, Laframboise S, Nofech-Mozes S, Ismiil N, Rasty G, Khalifa MACA. Radical vaginal trachelectomy vs. radical hysterectomy for small early stage cervical cancer: a matched case-control study. Gynecol Oncol 2008;110:168–71. PubMed

Dursun P, LeBlanc E NM. Radical vaginal trachelectomy (Dargent’s operation): a critical review of the literature. Eur J Surg Oncol 2007;33:933–41. PubMed

Hertel H Radical vaginal trachelectomy (RVT) combined with laparoscopic pelvic lymphadenectomy: prospective multicenter study of 100 patients with early cervical cancer. Gynecol Oncol 2006;103:506–11. PubMed

Ungar Laszlo, Palfalvi Laszlo, Hogg Russel, Siklos Pal, Boyle Deborah C.M., Giuseppe Del Priore J richard S. Abdominal radical trachelectomy: a fertility-preserving option for women with early-stage cervical cancer. BJOG an Int J Obstet Gynecol 2005;112:366–9. PubMed

Rene Pareja F, Ramirez PT, Borrero M, Angel G. Abdominal radical trachelectomy for invasive cervical cancer: a case series and literature review. Gynecol Oncol 2008;111:555–60. PubMed

Abu-Rustum NR, Sonoda Y, Black D, Levine DA, Chi DS, Barakat RR. Fertility- sparing radical abdominal trachelectomy for cervical carcinoma: Technique and review of the literature. Gynecol Oncol 2006;103:807–13. PubMed

Cibula D, Sláma J, Svárovsk J, Fischerova D, Freitag P, Zikán M, et al. Abdominal radical trachelectomy in fertility-sparing treatment of early-stage cervical cancer. Int J Gynecol Cancer 2009;19:1407–11. PubMed

Cǎpîlna ME, Ioanid N, Scripcariu V, Gavrilescu MM, Szabo B. Abdominal radical trachelectomy: A Romanian series. Int J Gynecol Cancer 2014;24:615–9. PubMed PMC

Ramirez PT, Schmeler KM, Malpica A, Soliman PT. Safety and feasibility of robotic radical trachelectomy in patients with early-stage cervical cancer. Gynecol Oncol 2010;116:512–5. PubMed

Vieira MA, Rendón GJ, Munsell M, Echeverri L, Frumovitz M, Schmeler KM, et al. Radical trachelectomy in early-stage cervical cancer: A comparison of laparotomy PubMed

and minimally invasive surgery. Gynecol Oncol 2015;138:585–9. Lu Q, Liu C, Zhang Z. Total laparoscopic radical trachelectomy in the treatment of early-stage cervical cancer. Curr Opin Obstet Gynecol 2014;26:302–7. PubMed

Park NY, Chong GO, Cho YL, Park ISLY. Total laparoscopic nerve-sparing radical trachelectomy. J Laparoendosc Adv Surg Tech A 2009;19:53–8. PubMed

Kucukmetin A, Biliatis I, Ratnavelu N, Patel A, Cameron I, Ralte A, et al. Laparoscopic radical trachelectomy is an alternative to laparotomy with improved perioperative outcomes in patients with early-stage cervical cancer. Int J Gynecol Cancer 2014;24:135–40. PubMed

Bentivegna E, Gouy S, Maulard A, Chargari C, Leary A, Morice P. Oncological outcomes after fertility-sparing surgery for cervical cancer: a systematic review. PubMed

Lancet Oncol 2016;17:e240–53. Ramirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, et al. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med 2018:NEJMoa1806395. PubMed

Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N CJ. Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inf 2009;42:377–81. PubMed PMC

Pareja R, Rendón GJ, Sanz-Lomana CM, Monzón O, Ramirez PT. Surgical, oncological, and obstetrical outcomes after abdominal radical trachelectomy – A systematic literature review. Gynecol Oncol 2013;131:77–82. PubMed

KE P and Nonparametric M estimation from incomplete observations. J Am Stat Assoc 1958;53:457–81.

Gooley TA, Leisenring W, Crowley J and SB. Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Stat Med 1999;18:695–706. PubMed

Fine JPGR. A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc 1999;94:496–509.

Melamed A, Margul DJ, Chen L, Keating NL, del Carmen MG, Yang J, et al..Survival after Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer. N Engl J Med 2018:NEJMoa1804923. PubMed PMC

Mo L Effects of a Simulated CO2 Pneumoperitoneum Environment on the Proliferation, Apoptosis, and Metastasis of Cervical Cancer Cells In Vitro. Med Sci Monit 2014;20:2497–503. PubMed PMC

Volz J, Köster S, Spacek Z, Paweletz N. The influence of pneumoperitoneum used in laparoscopic surgery on an intraabdominal tumor growth. Cancer 1999;86:770–4. PubMed

Open vs minimally invasive radical trachelectomy in early-stage cervical cancer: International Radical Trachelectomy Assessment Study