Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

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.

Radical 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.

Simple hysterectomy + pelvic lymph node dissection

Marie Plante

Gwenael Ferron

Jae-Weon Kim

Christian Marth

John Tidy

Noreen Gleeson

Frederic Goffin

Cor de Kroon

Xiaohua Wu

Sven Mahner

Brynhildur Eyjolfsdottir

Alexey Shevchuk

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.

At this time, it is not clear which of these approaches best balances the desire to prevent cancer of the cervix from returning with the risks of side effects after surgery and in the long-term.

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

A Randomized Phase III Trial Comparing Radical Hysterectomy and Pelvic Node Dissection vs Simple Hysterectomy and Pelvic Node Dissection in Patients With Low-Risk Early Stage Cervical Cancer (SHAPE)

Pelvic relapse-free survival (PRFS), the primary endpoint of this study, is defined as the time from randomization to the time of documented evidence of recurrence within the pelvic field.

compare the two treatment arms with respect to:

* pelvic relapse-free survival
* Extra pelvic relapse-free survival
* Relapse-free survival (any site)
* Overall survival
* Treatment-related adverse events
* Patient Reported Outcomes including global quality of life and measures of sexual health
* Cost-effectiveness and cost-utility
* To observe the rates of the following in this patient population: sentinel node detection.
* Parametrial involvement
* Involvement of surgical margins
* Pelvic node involvement

Gynecologic Cancer Intergroup (GCIG)

Canadian Institutes of Health Research (CIHR)

Korean Gynecologic Oncology Group

Dutch Gynecologic Oncology Group

Cancer Trials Ireland

Arbeitsgemeinschaft Gynaekologische Onkologie Austria

Belgium Gynecologic Oncology Group

Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens

Institute of Cancer Research, United Kingdom

Shanghai Cancer Centre Deptartment of Gynecologic Oncology Fudan University

Hertzen Moscow Scientific Research Institute of Oncology

Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom Germany

Institut Claudius Regaud - Institute Universitaire du Cancer de Toulouse - Oncopole

Canadian Cancer Trials Group

Spots Global Cancer Trial Database for simple hysterectomy + pelvic lymph node dissection