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International radical trachelectomy assessment: IRTA study
  1. Gloria Salvo1,
  2. Pedro T Ramirez1,
  3. Mario Leitao2,
  4. David Cibula3,
  5. Christina Fotopoulou4,
  6. Ali Kucukmetin5,
  7. Gabriel Rendon6,
  8. Myriam Perrotta7,
  9. Reitan Ribeiro8,9,
  10. Marcelo Vieira10,
  11. Glauco Baiocchi11,
  12. Henrik Falconer12,
  13. Jan Persson13,
  14. Xiaohua Wu14,
  15. Mihai Emil Căpilna15,
  16. Nicolae Ioanid16,
  17. Berit Jul Mosgaard17,
  18. Igor Berlev18,
  19. Dilyara Kaidarova19,
  20. Alexander Babatunde Olawaiye20,
  21. Kaijiang Liu21,
  22. Silvana Pedra Nobre2,
  23. Roman Kocian3,
  24. Srdjan Saso22,
  25. Stuart Rundle5,
  26. Florencia Noll7,
  27. Audrey Tieko Tsunoda8,9,
  28. Kolbrun Palsdottir12,
  29. Xiaoqi Li14,
  30. Elena Ulrikh18,
  31. Zhijun Hu21 and
  32. Rene Pareja23,24
  1. 1 Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA
  2. 2 Memorial Sloan Kettering Cancer Center, New York, USA
  3. 3 General University Hospital in Prague, First Faculty of Medicine, Charles University, Prague, Czech Republic
  4. 4 Department of Gynecologic Oncology, Imperial College London, London, UK
  5. 5 Queen Elizabeth Hospital, Gateshead, UK
  6. 6 Instituto de Cancerologia de las Americas, Medellin, Colombia
  7. 7 Ginecologia y Obstetricia, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
  8. 8 IOP Instituto de Oncologia do Parana, Curitiba, Brazil
  9. 9 Hospital Erasto Gaertner, Curitiba, Brazil
  10. 10 Hospital de Cancer de Barretos, Barretos, Brazil
  11. 11 A.C Camargo Cancer Center, São Paulo, Brazil
  12. 12 Karolinska Institutet, Stockholm, Sweden
  13. 13 Skane University Hospital, Scania, Sweden
  14. 14 Fudan University Shanghai Cancer Center, Shanghai, China
  15. 15 First Clinic of Obstetrics and Gynecology, University of Medicine and Pharmacy of Târgu Mureş, Târgu Mureş, Romania
  16. 16 The Regional Institute of Oncology of Iasi, Iasi, Romania
  17. 17 Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
  18. 18 North-Western State Medical University. N.N. Petrov Research Institute of Oncology, Saint-Petersburg, Russian Federation
  19. 19 Kazahskij naucno-issledovatel'skij institut onkologii i radiologii, Almaty, Kazakhstan
  20. 20 Gynecologic Oncology, UPMC, Pittsburgh, USA
  21. 21 RenJi Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
  22. 22 Department of Gynecologic Oncology, Imperial College London, London, UK
  23. 23 Oncological surgery, Clinica Astorga, Envigado, Colombia
  24. 24 Instituto Nacional del Cancer, Bogota, Colombia
  1. Correspondence to Dr Gloria Salvo, Department of Gynecologic Oncology & Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA; glorietasalvo{at}gmail.com

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.

  • cervical cancer
  • radical trachelectomy
  • fertility-sparing surgery
  • minimally invasive surgery
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Footnotes

  • Collaborators Brandelyn Pitcher; Bryan M Fellman.

  • Contributors GS, PTR, RP: conception or design of the work, drafting the article, critical revision of the article, final approval of the version to be published. ML, SPN, DC, RK, CF, SS, AK, SR, GR, MP, FN, RR, AT, MV, GB, HF, KP, JP, XW, XL, MEC, NI, KL, ZH, BJM, IB, EU, DK, ABO: data collection and final approval of the version to be published. BP, BMF: data analysis and interpretation.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Commissioned; internally peer reviewed.

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