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

NACompletedINTERVENTIONAL
Enrollment

700

Participants

Timeline

Start Date

December 10, 2012

Primary Completion Date

March 11, 2023

Study Completion Date

November 4, 2024

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.

Trial Locations (87)

1090

Medical University of Vienna, Vienna

3000

UZ Leuven, Leuven

4000

CHR de la Citadelle liege, Liège

CHU Sart Tilman Liege, Liège

4020

Landes- Frauen- und Kinderklinik Linz, Linz

5020

LKH Salzburg, Salzburg

6020

Medical University of Innsbruck, Innsbruck

8020

Barmherzige Brueder Graz, Graz

8036

Medical University of Graz, Graz

8700

LKH Leoben, Leoben

12559

DRK Kliniken Berlin Koepenick, Berlin

13273

Institut Paoli Calmettes - Marseille, Marseille

14050

DRK Klinikum Berlin Westend, Berlin

14193

Martin-Luther-Krankenhaus Berlin, Berlin

17475

Universitaetsfrauenklinik Greifswald, Greifswald

20246

Universitaetsklinikum Hamburg - Eppendorf, Hamburg

20259

Agaplesion Diakonieklinikum Hamburg, Hamburg

21079

Centre Georges Francois Leclerc - Dijon, Dijon

CHU de Dijon, Dijon

23538

Universitaetsfrauenklinik Luebeck, Lübeck

28211

GYNAEKOLOGICUM Bremen, Bremen

29609

CHRU de Brest, Brest

30029

CHU de Nimes, Nîmes

30625

Medizinische Hochschule Hannover, Hanover

31059

Institut Claudius Regaud - Toulouse, Toulouse

33076

Institut Bergonie Bordeaux, Bordeaux

33404

CHU de Bordeaux, Talence

34298

Institut Regional du Cancer de Montpellier, Montpellier

35033

CHU de Rennes, Rennes

35043

Clinique Mutualiste de la Sagesse - Rennes, Rennes

37044

CHRU de Tours, Tours

40225

Universitaetsfrauenklinik Duesseldorf, Düsseldorf

40489

Kaiserswerther Diakonie - Florence-Nightingale-Krankenhaus, Düsseldorf

44805

ICO - Rene Gauducheau, Saint-Herblain

45136

Kliniken Essen Mitte, Essen

51092

CHU de Reims, Reims

55131

Universitaetsfrauenklinik Mainz, Mainz

58452

Marien-Hospital Witten, Witten

59000

Centre Oscar Lambret - Lille, Lille

59037

CHRU de Lille, Lille

61352

Hochtaunus-Kliniken gGmbH, Bad Homburg

63003

CHU de Clermont-Ferrand, Clermont-Ferrand

63011

Centre Jean Perrin - Clermont-Ferrand, Clermont-Ferrand

66421

Universitaetsklinikum des Saarlandes, Homburg-Saar

67091

CHU de Strasbourg, Strasbourg

69229

Hospices Civils de Lyon, Lyon

69373

Centre Leon Berard - Lyon, Lyon

72076

Universitaetsfrauenklinik Tuebingen, Tübingen

73011

CHU de Chambery, Chambéry

75015

Hopital Europeen Georges Pompidou - Paris, Paris

76175

Clinique Mathilde - Rouen, Rouen

79106

Universitaetsfrauenklinik Freiburg, Freiburg im Breisgau

80054

CHU Amiens, Amiens

81377

Klinikum der Universitaet Muenchen - LMU Campus Grosshadern, München

87042

CHU Limoges, Limoges

89075

Universitaetsfrauenklinik Ulm, Ulm

200032

Shanghai Cancer Center, Shanghai

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V5Z 1M9

Clinical Research Unit at Vancouver Coastal, Vancouver

R3E 0V9

CancerCare Manitoba, Winnipeg

B3H 1V7

QEII Health Sciences Centre, Halifax

L4M 6M2

Royal Victoria Regional Health Centre, Barrie

N6A 5W9

London Regional Cancer Program, London

L5M 2N1

Trillium Health Partners - Credit Valley Hospital, Mississauga

K1H 8L6

Ottawa Hospital Research Institute, Ottawa

M5G 2M9

University Health Network, Toronto

J4V 2H1

Greenfield Park

H1T 2M4

CIUSSS de l'Est-de-I'lle-de-Montreal, Montreal

H2X 3E4

CHUM-Centre Hospitalier de l'Universite de Montreal, Montreal

H3T 1E2

The Jewish General Hospital, Montreal

G1R 2J6

Québec

J1H 5N4

CIUSSS de l'Estrie - Centre hospitalier, Sherbrooke

06254

Institut Arnault Tzank - Mougins, Mougins

06003

CHU de Nice, Nice

07747

Universitaetsfrauenklinik Jena, Jena

Dublin 8

St James Hospital, Dublin

2300 RC

LUMC, Leiden

3000CA

Erasmus MC, Rotterdam

0424

Oslo University Hospital, Oslo

Unknown

Hertzen Moscow Scientific Research, Moscow

TR1 3LJ

Royal Cornwall Hospital, Truro

SS0 0RY

Southend University Hospital, Westcliff-on-Sea

CT1 3NG

East Kent Hospitals University NHS Foundation Trust, Canterbury

S10 2TJ

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

TS4 3BW

South Tees Hospitals NHS Foundation Trust, Middlesbrough

PO6 3LY

Queen Alexandra Hospital, Portsmouth

All Listed Sponsors
collaborator

Gynecologic Cancer Intergroup (GCIG)

OTHER

collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

Korean Gynecologic Oncology Group

OTHER

collaborator

Dutch Gynaecological Oncology Group

OTHER

collaborator

Cancer Trials Ireland

NETWORK

collaborator

Arbeitsgemeinschaft Gynaekologische Onkologie Austria

OTHER

collaborator

Belgian Gynaecological Oncology Group

OTHER

collaborator

ARCAGY/ GINECO GROUP

OTHER

collaborator

Institute of Cancer Research, United Kingdom

OTHER

collaborator

Shanghai Cancer Centre

OTHER

collaborator

P. Herzen Moscow Oncology Research Institute

OTHER_GOV

collaborator

Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom Germany

OTHER

collaborator

Institut Universitaire du Cancer de Toulouse

OTHER

lead

Canadian Cancer Trials Group

NETWORK

NCT01658930 - Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer | Biotech Hunter | Biotech Hunter