Objective: The aim of this prospective clinical multicenter study "Uterus 6" of the German Association of Gynecologic Oncologists (AGO) was to prove the recurrence rate of patients treated with pelvic lymphadenectomy and radical vaginal trachelectomy (RVT). We also wanted to prove the surgical safety of RVT.
Methods: Between March 1995 and November 2005, we intend to treat 108 patients with cervical cancer (TNM stage 1A1, L1 n = 18, 1A2 n = 21, 1B1 n = 69) by RVT. Eight patients were excluded since the study criteria were not met after RVT (tumor size >2 cm, neuroendocrine tumor type, tumor-involved resection margins, or positive pelvic lymph nodes). Thus, 100 patients were treated by RVT according to protocol. With 4 recurrences in a sample size of 100 patients, an upper limit of the 95% confidence interval (including continuity correction) of 10.5% was calculated. Recruitment had to be stopped if five or more recurrences occurred.
Results: The median follow-up time was 29 (1-128) months. Three (3%) recurrences occurred in 100 patients treated with RVT according to protocol. Thus, the upper confidence limit was 9.2%. The projected 5-year recurrence-free and overall survival rates were 97% and 98%. The average duration of surgery was 253 (115-402) min. Perioperative complications were: postoperative bleeding, embolism of the external iliac artery, retroperitoneal lymphocele, or paralytic ileus in one patient, respectively.
Conclusions: RVT combined with laparoscopic pelvic and parametric lymphadenectomy for treatment of patients with early stage cervical cancer < or =2 cm results in a recurrence-free survival of more than 90.8%.