Robot-assisted approach to cervical cancer (RACC): an international multi-center, open-label randomized controlled trial

Abstract

BackgroundRadical hysterectomy with pelvic lymphadenectomy represents the standard treatment for early-stage cervical cancer. Results from a recent randomized controlled trial demonstrate that minimally invasive surgery is inferior to laparotomy with regards to disease-free and overall survival.Primary ObjectiveTo investigate the oncologic safety of robot-assisted surgery for early-stage cervical cancer as compared with standard laparotomy.Study HypothesisRobot-assisted laparoscopic radical hysterectomy is non-inferior to laparotomy in regards to recurrence-free survival with the advantage of fewer post-operative complications and superior patient-reported outcomes.Trial DesignProspective, multi-institutional, international, open-label randomized clinical trial. Consecutive women with early-stage cervical cancer will be assessed for eligibility and subsequently randomized 1:1 to either robot-assisted laparoscopic surgery or laparotomy. Institutional review board approval will be required from all participating institutions. The trial is coordinated from Karolinska University Hospital, Sweden.Major Inclusion/Exclusion CriteriaWomen over 18 with cervical cancer FIGO (2018) stages IB1, IB2, and IIA1 squamous, adenocarcinoma, or adenosquamous will be included. Women are not eligible if they have evidence of metastatic disease, serious co-morbidity, or a secondary invasive neoplasm in the past 5 years.Primary EndpointRecurrence-free survival at 5 years between women who underwent robot-assisted laparoscopic surgery versus laparotomy for early-stage cervical cancer.Sample SizeThe clinical non-inferiority margin in this study is defined as a 5-year recurrence-free survival not worsened by >7.5%. With an expected recurrence-free survival of 85%, the study needs to observe 127 events with a one-sided level of significance (α) of 5% and a power (1−β) of 80%. With 5 years of recruitment and 3 years of follow-up, the necessary number of events will be reached if the study can recruit a total of 768 patients.Estimated Dates for Completing Accrual and Presenting ResultsTrial launch is estimated to be May 2019 and the trial is estimated to close in May 2027 with presentation of data shortly thereafter.Trial RegistrationThe trial is registered at ClinicalTrials.gov (NCT03719547).

SUCCOR study: an international European cohort observational study comparing minimally invasive surgery versus open abdominal radical hysterectomy in patients with stage IB1 cervical cancer

“…The second one is a multicenter randomized controlled trial designed in China. 32 Again, in their protocol, the use of uterine manipulator and the method of vaginal excision is to be reported.…”

Comparison of long-term survival of total abdominal radical hysterectomy and laparoscopy-assisted radical vaginal hysterectomy in patients with early cervical cancer: Korean multicenter, retrospective analysis

“…The non-inferiority of survival outcomes of LARVH compared with TARH were assessed by 5-year PFS and OS difference of the between-group (LARVH minus TARH) with a non-inferiority margin of −7.2%. This was based on results from LACC-trial and other similar trials [11,19]. Non-inferiority of LARVH was rejected if the lower limit of the 95% confidence interval (CI) of the between-group difference (LARVH minus TARH) was less than the non-inferiority margin of −7.2%.…”

On Quality Improvement in Gynaecological Cancer Surgery

“…Cancer recurrence and disease-free survival are issues that still need to be further explored before the expensive robotic technique can be fully accepted, even if laparoscopic and some robotic evidence does not show any difference in oncologic safety in endometrial cancer (Koskas, et al 2016, Lindfors, et al 2018. Recently, a randomised trial started called "Robot-assisted approach to cervical cancer (RACC)", an international multicentre open-label study between robotic and abdominal radical hysterectomy with pelvic lymphadenectomy for woman with cervical cancer, studying the five-year recurrence-free survival, postoperative complications and patient-reported outcomes (Falconer, et al 2019).…”