About this trial
This study is a multicenter, open-label, non-inferiority, randomized controlled, investigator-initiated clinical trial comparing the efficacy and safety of open radical hysterectomy versus minimally invasive radical hysterectomy using an endoscopic stapler as surgical treatments for early cervical cancer.
Eligibility criteria
Qualifiers
2018 FIGO stage IB2 or IIA1 cervical cancer (tumor maximum diameter ≥2 cm and <4 cm)
Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
Planned for Type B or C radical hysterectomy
With adequate bone marrow, renal, and hepatic function
Disqualifiers
Histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
Tumor size less than 2 cm classified as 2018 FIGO stage IA1, IA2, or IB1 disease
The following are observed on preoperative CT or MRI
Tumor size ≥4 cm
Trial design
Treatments tested in this trial
- Open radical hysterectomy
- Minimally invasive radical hysterectomy
Treatment groups
Sponsors and collaborators
Seoul National University Hospital
Lead sponsor
Ajou University School of Medicine
Collaborator
SMG-SNU Boramae Medical Center
Collaborator
Konkuk University
Collaborator
DongGuk University
Collaborator
Keimyung University
Collaborator
National Cancer Center, Korea
Collaborator
The Catholic University of Korea
Collaborator
Wonju Severance Christian Hospital
Collaborator
Kangbuk Samsung Hospital
Collaborator
Asan Medical Center
Collaborator
Samsung Medical Center
Collaborator
Sinchon Severance Hospital, Yonsei University College of Medicine
Collaborator