Minimally Invasive Radical Hysterectomy Using Endoscopic Stapler in Stage IB2 or IIA1 Cervical Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20+
SponsorSeoul National University Hospital

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

494 Participants
are divided into 2 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