Clinical Trial of Minimally Invasive Surgery Versus Abdominal Surgery in Patients With Early Stage Cervical Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

minimally invasive surgery: Laparoscopic or robotic assisted radical hysterectomy

open abdominal surgery: Traditional open abdominal radical hysterectomy

Study summary

Cervical cancer is the most common cause of death from gynecological cancer world-wide. With technological innovation, minimally invasive or even non-invasive medical treatment has become a trend. Since the first cases of laparoscopic radical hysterectomy of cervical cancer have been reported in 1992, many single-center observational cohort studies have shown that compared to open abdominal surgery ，minimally invasive surgery (laparoscopic or robotic radical hysterectomy) showed advantages of less blood loss, shorter hospital stay and fewer intraoperative complications, while the 5-year survival and disease-free survival were similar. The NCCN guidelines and ESGO recommendations also clearly indicated that patients with FIGO stage IA2 -IIA cervical cancer could undergo open or laparoscopic/robotic radical hysterectomy. However, in October 2018, the results of two studies published in the《New England Journal of Medicine》have subverted our traditional perception of minimally invasive surgery and caused widespread controversy in the field of gynecologic oncology treatment. Both studies showed that the survival rate in the minimally invasive surgery group was lower than that in the open surgery group.

The results of these two studies have brought unprecedented doubts and challenges to the minimally invasive surgery for cervical cancer. The MD Anderson Cancer Center has even stopped minimally invasive surgery for cervical cancer. Several hospitals in Hong Kong have responded similarly. The NCCN guidelines are also quickly updated based on the results of those studies: patients should be informed of the results of this study and doctors should respect the patient's choices. The above research results have also attracted the attention of many gynecological oncologists in the mainland China. Some experts questioned the design of this study design as well as surgical skills. We need to look at these findings cautiously. So, we launched a real-world study of clinical outcomes affected by different surgical treatment for patients of early stage cervical cancer. We plan to recruit 2000 patients with early cervical cancer from 20-30 selected surgical centers nationwide and perform surgery on patients with qualified and experienced doctors.We will inform the patients current status of the study in detail, divide the patients into different observational group according to their choices on surgical methods. The patients will be followed up closely after surgery. We will compare the differences in clinical outcomes between the two surgical methods and conduct subgroup and stratified analysis. We hope that this study can truly reflect the actual status and clinical l level of early cervical cancer treatment in China, and provide a high level of clinical evidence for the treatment of cervical cancer in China .

Eligibility

Primary outcome measure(s)

• disease-free survival (DFS) of 3 years — 3 years
  DFS was definite as the time from surgery to disease recurrence
• overall survival (OS) of 5 years — up to 5 years
  OS was defined as time from surgery to death by any cause

Trial sites (1)

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