Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer

Summary

The reason this study is being done is to see if a simple hysterectomy is as good as a radical hysterectomy in preventing cancer of the cervix from returning, and whether, because less tissue surrounding the uterus is removed during surgery, there are fewer side-effects after the surgery and in the long-term.

Conditions

• Cervical Cancer

Interventions

PROCEDURE

Radical Hysterectomy + pelvic lymph node dissection

This procedure may be performed abdominally, laparoscopically, robotically or vaginally. The uterus, cervix, medial 1/3 of parametria, 2cm of the uterosacral ligaments and upper 1-2cm of the vagina are to be removed en bloc. The uterine artery is ligated laterally to the ureters and the ureters are unroofed to the ureterovesical junction.

PROCEDURE

Simple hysterectomy + pelvic lymph node dissection

This procedure may be performed abdominally, laparoscopically, robotically or vaginally. Extrafascial hysterectomy involves removal of the uterus with cervix without adjacent parametria. The uterine arteries are transected medial to the ureters at the level of the isthmus and the uterosacral ligaments are transected at the level of the cervix. Surgeons should pay special attention to make sure that the whole cervix is removed. As such, a maximum of 0.5 cm of vaginal cuff can be removed to ensure the complete removal of the cervix.

Sponsors & Collaborators

• Gynecologic Cancer Intergroup (GCIG)

  collaborator OTHER

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Korean Gynecologic Oncology Group

  collaborator OTHER

• Dutch Gynaecological Oncology Group

  collaborator OTHER

• Cancer Trials Ireland

  collaborator NETWORK

• Arbeitsgemeinschaft Gynaekologische Onkologie Austria

  collaborator OTHER

• Belgian Gynaecological Oncology Group

  collaborator OTHER

• ARCAGY/ GINECO GROUP

  collaborator OTHER

• Institute of Cancer Research, United Kingdom

  collaborator OTHER

• Shanghai Cancer Centre

  collaborator OTHER

• P. Herzen Moscow Oncology Research Institute

  collaborator OTHER_GOV

• Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom Germany

  collaborator OTHER

• Institut Universitaire du Cancer de Toulouse

  collaborator OTHER

• Canadian Cancer Trials Group

  lead NETWORK

Principal Investigators

• Marie Plante · Canadian Cancer Trials Group

• Gwenael Ferron · France-GINECO

• Jae-Weon Kim · Korean Gynecology Oncology Group

• Christian Marth · Arbeitsgemeinschaft Gynaekologische Onkologie Austria

• John Tidy · Institute of Cancer Research, United Kingdom

• Noreen Gleeson · Ireland Co-operative Oncology Research Group

• Frederic Goffin · Belgian Gynaecological Oncology Group

• Cor de Kroon · The Dutch Gynecological Oncology Group (DGOG)

• Xiaohua Wu · Fudan University

• Sven Mahner · AGO Germany

• Brynhildur Eyjolfsdottir · Oslo University Hospital

• Alexey Shevchuk · Hertzen Institute, Moscow

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-10

Primary Completion

2023-03-11

Completion

2024-11-04

Countries

• Austria
• Belgium
• Canada
• China
• France
• Germany
• Ireland
• Netherlands
• Norway
• Russia
• United Kingdom

Study Locations