Spots Global Cancer Trial Database for Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer
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Trial Identification
Brief Title: Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer
Official Title: 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)
Study ID: NCT01658930
Conditions
Study Description
Brief 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Barmherzige Brueder Graz, Graz, , Austria
Medical University of Graz, Graz, , Austria
Medical University of Innsbruck, Innsbruck, , Austria
LKH Leoben, Leoben, , Austria
Landes- Frauen- und Kinderklinik Linz, Linz, , Austria
LKH Salzburg, Salzburg, , Austria
Medical University of Vienna, Vienna, , Austria
UZ Leuven, Leuven, Vlaams-Brabant, Belgium
CHR de la Citadelle liege, Liege, , Belgium
CHU Sart Tilman Liege, Liege, , Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Clinical Research Unit at Vancouver Coastal, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Trillium Health Partners - Credit Valley Hospital, Mississauga, Ontario, Canada
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
University Health Network, Toronto, Ontario, Canada
, Greenfield Park, Quebec, Canada
CIUSSS de l'Est-de-I'lle-de-Montreal, Montreal, Quebec, Canada
CHUM-Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
The Jewish General Hospital, Montreal, Quebec, Canada
, Quebec City, Quebec, Canada
CIUSSS de l'Estrie - Centre hospitalier, Sherbrooke, Quebec, Canada
Shanghai Cancer Center, Shanghai, , China
CHU Amiens, Amiens, , France
Institut Bergonie Bordeaux, Bordeaux, , France
CHRU de Brest, Brest, , France
CHU de Chambery, Chambery, , France
Centre Jean Perrin - Clermont-Ferrand, Clermont Ferrand, , France
CHU de Clermont-Ferrand, Clermont-Ferrand, , France
Centre Georges Francois Leclerc - Dijon, Dijon, , France
CHU de Dijon, Dijon, , France
Centre Oscar Lambret - Lille, Lille, , France
CHRU de Lille, Lille, , France
CHU Limoges, Limoges, , France
Hospices Civils de Lyon, Lyon, , France
Centre Leon Berard - Lyon, Lyon, , France
Institut Paoli Calmettes - Marseille, Marseille, , France
Institut Regional du Cancer de Montpellier, Montpellier, , France
Institut Arnault Tzank - Mougins, Mougins, , France
CHU de Nice, Nice, , France
CHU de Nimes, Nimes, , France
Hopital Europeen Georges Pompidou - Paris, Paris, , France
CHU de Reims, Reims, , France
CHU de Rennes, Rennes, , France
Clinique Mutualiste de la Sagesse - Rennes, Rennes, , France
Clinique Mathilde - Rouen, Rouen, , France
ICO - Rene Gauducheau, Saint-Herblain, , France
CHU de Strasbourg, Strasbourg, , France
CHU de Bordeaux, Talence, , France
Institut Claudius Regaud - Toulouse, Toulouse, , France
CHRU de Tours, Tours, , France
Hochtaunus-Kliniken gGmbH, Bad Homburg, , Germany
DRK Kliniken Berlin Koepenick, Berlin, , Germany
DRK Klinikum Berlin Westend, Berlin, , Germany
Martin-Luther-Krankenhaus Berlin, Berlin, , Germany
GYNAEKOLOGICUM Bremen, Bremen, , Germany
Universitaetsfrauenklinik Duesseldorf, Duesseldorf, , Germany
Kaiserswerther Diakonie - Florence-Nightingale-Krankenhaus, Duesseldorf, , Germany
Kliniken Essen Mitte, Essen, , Germany
Universitaetsfrauenklinik Freiburg, Freiburg, , Germany
Universitaetsfrauenklinik Greifswald, Greifswald, , Germany
Universitaetsklinikum Hamburg - Eppendorf, Hamburg, , Germany
Agaplesion Diakonieklinikum Hamburg, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitaetsklinikum des Saarlandes, Homburg-Saar, , Germany
Universitaetsfrauenklinik Jena, Jena, , Germany
Universitaetsfrauenklinik Luebeck, Luebeck, , Germany
Universitaetsfrauenklinik Mainz, Mainz, , Germany
Klinikum der Universitaet Muenchen - LMU Campus Grosshadern, Muenchen, , Germany
Universitaetsfrauenklinik Tuebingen, Tuebingen, , Germany
Universitaetsfrauenklinik Ulm, Ulm, , Germany
Marien-Hospital Witten, Witten, , Germany
St James Hospital, Dublin, Leinster, Ireland
LUMC, Leiden, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Oslo University Hospital, Oslo, Postboks 4953 Nydalen, Norway
Hertzen Moscow Scientific Research, Moscow, , Russian Federation
Royal Cornwall Hospital, Truro, Cornwall, United Kingdom
Southend University Hospital, Westcliff-on-Sea, Essex, United Kingdom
East Kent Hospitals University NHS Foundation Trust, Canterbury, Ethelbert Road, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, Glossop Road, United Kingdom
South Tees Hospitals NHS Foundation Trust, Middlesbrough, Marton Road, United Kingdom
Queen Alexandra Hospital, Portsmouth, , United Kingdom
Contact Details
Name: Marie Plante
Affiliation: Canadian Cancer Trials Group
Role: STUDY_CHAIR
Name: Gwenael Ferron
Affiliation: France-GINECO
Role: STUDY_CHAIR
Name: Jae-Weon Kim
Affiliation: Korean Gynecology Oncology Group
Role: STUDY_CHAIR
Name: Christian Marth
Affiliation: Arbeitsgemeinschaft Gynaekologische Onkologie Austria
Role: STUDY_CHAIR
Name: John Tidy
Affiliation: Institute of Cancer Research, United Kingdom
Role: STUDY_CHAIR
Name: Noreen Gleeson
Affiliation: Ireland Co-operative Oncology Research Group
Role: STUDY_CHAIR
Name: Frederic Goffin
Affiliation: Belgian Gynaecological Oncology Group
Role: STUDY_CHAIR
Name: Cor de Kroon
Affiliation: The Dutch Gynecological Oncology Group (DGOG)
Role: STUDY_CHAIR
Name: Xiaohua Wu
Affiliation: Fudan University
Role: STUDY_CHAIR
Name: Sven Mahner
Affiliation: AGO Germany
Role: STUDY_CHAIR
Name: Brynhildur Eyjolfsdottir
Affiliation: Oslo University Hospital
Role: STUDY_CHAIR
Name: Alexey Shevchuk
Affiliation: Hertzen Institute, Moscow
Role: STUDY_CHAIR
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