Efficacy of different surgical approaches in the clinical and survival outcomes of patients with early-stage cervical cancer: protocol of a phase III multicentre randomised controlled trial in China

Abstract

IntroductionIn the last three decades, minimally invasive surgery (MIS) for radical hysterectomy (RH) has become a popular treatment option for early-stage cervical cancer. However, a recently published randomised controlled trial (LACC trial) and an epidemiological study in the USA revealed strong evidence against the survival advantage of MIS for RH. However, the influencing factors of research centres and the learning curves of surgeons in these studies lacked sufficient evaluation. The efficacy of different surgical approaches for early-stage cervical cancer in the clinical and survival outcomes remains to be validated.Methods and analysisPatients diagnosed with FIGO (2009) stage IA1 (with lymphovascular space invasion), IA2 or IB1 cervical cancer with histological subtype of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma will be recruited in this multicentre randomised controlled study. Patients will be randomly assigned to undergo MIS (robot-assisted or laparoscopic RH) or abdominal RH. Within 2 years, 1448 patients in 28 centres in China will be recruited to meet the criteria of a non-inferiority threshold of HR of 1.6 with bilateral nominal α <0.05 and power of 0.8. All surgeries will be performed by the indicated experienced surgeons. At least 100 RH cases in the individual past one decade of practice will be analysed as proof of learning curves. The primary objective of this study is 5-year disease-free survival. The secondary objectives include the overall survival rate, progression-free survival rate, disease-free survival rate, cost-effectiveness and quality of life.Ethics and disseminationThis study has been approved by the Institutional Review Board of Peking Union Medical College Hospital and is filed on record by all other centres. Written informed consent will be obtained from all eligible participants before enrolment. The results will be disseminated through community events, academic conferences, student theses and peer-reviewed journals.Trial registration numberNCT03739944.

Efficacy of different surgical approaches on survival outcomes in patients with early-stage cervical cancer: protocol for a multicentre longitudinal study in China

“…28 Chinese centres (online supplementary file 1), same as the RACC trial 36 will collect patients' medical records. Each expert included in this study will provide the medical records of at least 100 consecutive patients who were hospitalised between 1 January 2009 and 31 December 2015, according to a predefined template.…”

“…36 This trial is based on a participating expert-centred design rather than a study site-centred design. 36 However, the two most important questions that arose from the RACC study (NCT03739944) await answers. One is the safety of MIRH for patients with early-stage cervical cancer that was inferior, reported in the Laparoscopic Approach to Cervical Cancer (LACC) trial and other studies.…”

“…Some authors also argued that the reduction in survival in patients receiving MIRH could be due to tumour manipulation and subsequent cancer spread. 48 In general, based on the participating surgeons of an RCT, 36 we will perform this multicentre longitudinal study to compare the survival outcomes of patients undergoing ARH and MIRH and to qualify the learning curves of participating surgeons. Other essential issues, including tumour diameters and definite surgical procedures which were considered as potential risk factors, will be also evaluated in this study.…”

Reply

“…Additional trials are welcome. Results of studies such as NCT03739944, which require participating surgeons to have completed at minimum of 100 radical hysterectomies for early-stage cervical cancer over 10 years, 5 can be generalized only to maximally experienced gynecologic oncologists. At this time, the best evidence available from the LACC trial illustrates significantly reduced survival following MH.…”

<p>Perioperative Complications and Safety Evaluation of Robot-Assisted Radical Hysterectomy of Cervical Cancer After Neoadjuvant Chemotherapy</p>

“…In previous studies, a great deal of articles focused on the long-term effects after RRH, [9][10][11][12][13] while researches on the short-term effects were rare relatively. In order to better evaluate this therapeutic approach, we concentrated on the short-term perioperative impacts of RRH on patients.…”