Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer
SHAPE
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)
1 other identifier
interventional
700
11 countries
87
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2012
CompletedFirst Posted
Study publicly available on registry
August 7, 2012
CompletedStudy Start
First participant enrolled
December 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2024
CompletedResults Posted
Study results publicly available
November 22, 2024
CompletedDecember 17, 2024
November 1, 2024
10.3 years
August 3, 2012
May 31, 2024
November 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Pelvic Recurrence Rate at 3 Years
Pelvic recurrence rate at 3 years was estimated by 1-the Kaplan-Meier estimate for the probability of pelvic relapse free survival (PRFS) at 3 years. PRFS was defined as the time from randomization to the time when a recurrence within the pelvic field was first documented. Patients who had a relapse outside of the pelvic field documented or died before the documentation of a pelvic relapse were censored at the time of first documented extra-pelvic relapse or death. The pelvic relapse free survival of patients who were alive without any relapse at the time of final analysis was censored at the last known alive.
3 years
Secondary Outcomes (4)
Pelvic Relapse-free Survival
3 years
Extra-pelvic Relapse-free Survival
3 years
Relapse-free Survival
3 years
Overall Survival
3 years
Study Arms (2)
Radical Hysterectomy
ACTIVE COMPARATORSimple Hysterectomy
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix. Diagnosis has been made by LEEP, cone or cervical biopsy and has been reviewed and confirmed by the local reference gynecological pathologist.
- Patient has been classified as low-risk early-stage cervical cancer. These patients include:
- FIGO Stage IA2 \[FIGO Annual Report, 2009\], defined as:
- o evidence of disease by microscopy;
- for patients who underwent a LEEP or cone:
- histologic evidence of depth of stromal invasion \> 3.0 and ≤ 5.0 mm based on the local reference pathologist's measurement of the LEEP or cone specimen NB: the maximum depth of stromal invasion must be ≤ 10 mm.
- histologic evidence of lateral extension that is ≤ 7.0 mm based on the local reference pathologist's measurement of the LEEP or cone specimen; and
- negative margins (patients with positive margins are considered IB1, see below)
- for patients who underwent a cervical biopsy only:
- radiologic evidence of less than 50% stromal invasion based on pelvic MRI
- FIGO Stage IB1 \[FIGO Annual Report, 2009\] with favorable (low risk) features, defined as:
- measured stromal invasion and lateral extension that meet the criteria for IA2 (see above) but with positive margins;
- evidence of disease by clinical exam; lesion must clinically measure ≤ 20 mm
- evidence of disease by microscopy;
- for patients who underwent a LEEP or cone:
- +18 more criteria
You may not qualify if:
- Patients with FIGO 1A1 disease \[FIGO Annual Report, 2009\].
- History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours, Hodgkin's lymphoma or non-Hodgkin's lymphoma curatively treated with no evidence of disease for \> 5 years.
- Patients with evidence of lymph node metastasis on preoperative imaging or histology.
- Patients who have had or will receive neoadjuvant chemotherapy.
- Patients who are pregnant.
- Patients for whom adjuvant radiation and/or chemotherapy is planned.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Canadian Cancer Trials Grouplead
- Gynecologic Cancer Intergroup (GCIG)collaborator
- Canadian Institutes of Health Research (CIHR)collaborator
- Korean Gynecologic Oncology Groupcollaborator
- Dutch Gynaecological Oncology Groupcollaborator
- Cancer Trials Irelandcollaborator
- Arbeitsgemeinschaft Gynaekologische Onkologie Austriacollaborator
- Belgian Gynaecological Oncology Groupcollaborator
- ARCAGY/ GINECO GROUPcollaborator
- Institute of Cancer Research, United Kingdomcollaborator
- Shanghai Cancer Centrecollaborator
- P. Herzen Moscow Oncology Research Institutecollaborator
- Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom Germanycollaborator
- Institut Universitaire du Cancer de Toulousecollaborator
Study Sites (87)
Barmherzige Brueder Graz
Graz, 8020, Austria
Medical University of Graz
Graz, 8036, Austria
Medical University of Innsbruck
Innsbruck, 6020, Austria
LKH Leoben
Leoben, 8700, Austria
Landes- Frauen- und Kinderklinik Linz
Linz, 4020, Austria
LKH Salzburg
Salzburg, 5020, Austria
Medical University of Vienna
Vienna, 1090, Austria
UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
CHR de la Citadelle liege
Liège, 4000, Belgium
CHU Sart Tilman Liege
Liège, 4000, Belgium
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Clinical Research Unit at Vancouver Coastal
Vancouver, British Columbia, V5Z 1M9, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
London Regional Cancer Program
London, Ontario, N6A 5W9, Canada
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6, Canada
University Health Network
Toronto, Ontario, M5G 2M9, Canada
Unknown Facility
Greenfield Park, Quebec, J4V 2H1, Canada
CIUSSS de l'Est-de-I'lle-de-Montreal
Montreal, Quebec, H1T 2M4, Canada
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
The Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Unknown Facility
Québec, Quebec, G1R 2J6, Canada
CIUSSS de l'Estrie - Centre hospitalier
Sherbrooke, Quebec, J1H 5N4, Canada
Shanghai Cancer Center
Shanghai, 200032, China
CHU Amiens
Amiens, 80054, France
Institut Bergonie Bordeaux
Bordeaux, 33076, France
CHRU de Brest
Brest, 29609, France
CHU de Chambery
Chambéry, 73011, France
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003, France
Centre Jean Perrin - Clermont-Ferrand
Clermont-Ferrand, 63011, France
Centre Georges Francois Leclerc - Dijon
Dijon, 21079, France
CHU de Dijon
Dijon, 21079, France
Centre Oscar Lambret - Lille
Lille, 59000, France
CHRU de Lille
Lille, 59037, France
CHU Limoges
Limoges, 87042, France
Hospices Civils de Lyon
Lyon, 69229, France
Centre Leon Berard - Lyon
Lyon, 69373, France
Institut Paoli Calmettes - Marseille
Marseille, 13273, France
Institut Regional du Cancer de Montpellier
Montpellier, 34298, France
Institut Arnault Tzank - Mougins
Mougins, 06254, France
CHU de Nice
Nice, 06003, France
CHU de Nimes
Nîmes, 30029, France
Hopital Europeen Georges Pompidou - Paris
Paris, 75015, France
CHU de Reims
Reims, 51092, France
CHU de Rennes
Rennes, 35033, France
Clinique Mutualiste de la Sagesse - Rennes
Rennes, 35043, France
Clinique Mathilde - Rouen
Rouen, 76175, France
ICO - Rene Gauducheau
Saint-Herblain, 44805, France
CHU de Strasbourg
Strasbourg, 67091, France
CHU de Bordeaux
Talence, 33404, France
Institut Claudius Regaud - Toulouse
Toulouse, 31059, France
CHRU de Tours
Tours, 37044, France
Hochtaunus-Kliniken gGmbH
Bad Homburg, 61352, Germany
DRK Kliniken Berlin Koepenick
Berlin, 12559, Germany
DRK Klinikum Berlin Westend
Berlin, 14050, Germany
Martin-Luther-Krankenhaus Berlin
Berlin, 14193, Germany
GYNAEKOLOGICUM Bremen
Bremen, 28211, Germany
Universitaetsfrauenklinik Duesseldorf
Düsseldorf, 40225, Germany
Kaiserswerther Diakonie - Florence-Nightingale-Krankenhaus
Düsseldorf, 40489, Germany
Kliniken Essen Mitte
Essen, 45136, Germany
Universitaetsfrauenklinik Freiburg
Freiburg im Breisgau, 79106, Germany
Universitaetsfrauenklinik Greifswald
Greifswald, 17475, Germany
Universitaetsklinikum Hamburg - Eppendorf
Hamburg, 20246, Germany
Agaplesion Diakonieklinikum Hamburg
Hamburg, 20259, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitaetsklinikum des Saarlandes
Homburg-Saar, 66421, Germany
Universitaetsfrauenklinik Jena
Jena, 07747, Germany
Universitaetsfrauenklinik Luebeck
Lübeck, 23538, Germany
Universitaetsfrauenklinik Mainz
Mainz, 55131, Germany
Klinikum der Universitaet Muenchen - LMU Campus Grosshadern
München, 81377, Germany
Universitaetsfrauenklinik Tuebingen
Tübingen, 72076, Germany
Universitaetsfrauenklinik Ulm
Ulm, 89075, Germany
Marien-Hospital Witten
Witten, 58452, Germany
St James Hospital
Dublin, Leinster, Dublin 8, Ireland
LUMC
Leiden, 2300 RC, Netherlands
Erasmus MC
Rotterdam, 3000CA, Netherlands
Oslo University Hospital
Oslo, Postboks 4953 Nydalen, 0424, Norway
Hertzen Moscow Scientific Research
Moscow, Russia
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ, United Kingdom
Southend University Hospital
Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
East Kent Hospitals University NHS Foundation Trust
Canterbury, Ethelbert Road, CT1 3NG, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, Glossop Road, S10 2TJ, United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, Marton Road, TS4 3BW, United Kingdom
Queen Alexandra Hospital
Portsmouth, PO6 3LY, United Kingdom
Related Publications (4)
Plante M, Kwon JS, Ferguson S, Samouelian V, Ferron G, Maulard A, de Kroon C, Van Driel W, Tidy J, Williamson K, Mahner S, Kommoss S, Goffin F, Tamussino K, Eyjolfsdottir B, Kim JW, Gleeson N, Brotto L, Tu D, Shepherd LE; CX.5 SHAPE investigators; CX.5 SHAPE Investigators. Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer. N Engl J Med. 2024 Feb 29;390(9):819-829. doi: 10.1056/NEJMoa2308900.
PMID: 38416430RESULTKwon JS, McTaggart-Cowan H, Ferguson SE, Samouelian V, Lambaudie E, Guyon F, Tidy J, Williamson K, Gleeson N, de Kroon C, van Driel W, Mahner S, Hanker L, Goffin F, Berger R, Eyjolfsdottir B, Kim JW, Brotto LA, Pataky R, Yeung SST, Chan KKW, Cheung MC, Ubi J, Tu D, Shepherd LE, Plante M. Cost-effectiveness analysis of simple hysterectomy compared to radical hysterectomy for early cervical cancer: analysis from the GCIG/CCTG CX.5/SHAPE trial. J Gynecol Oncol. 2024 Nov;35(6):e117. doi: 10.3802/jgo.2024.35.e117. Epub 2024 Oct 18.
PMID: 39453395DERIVEDFerguson SE, Brotto LA, Kwon J, Samouelian V, Ferron G, Maulard A, Kroon C, Driel WV, Tidy J, Williamson K, Mahner S, Kommoss S, Goffin F, Tamussino K, Eyjolfsdottir B, Kim JW, Gleeson N, Tu D, Shepherd L, Plante M. Sexual Health and Quality of Life in Patients With Low-Risk Early-Stage Cervical Cancer: Results From GCIG/CCTG CX.5/SHAPE Trial Comparing Simple Versus Radical Hysterectomy. J Clin Oncol. 2025 Jan 10;43(2):167-179. doi: 10.1200/JCO.24.00440. Epub 2024 Oct 1.
PMID: 39353164DERIVEDBoisen M, Guido R. Emerging Treatment Options for Cervical Dysplasia and Early Cervical Cancer. Clin Obstet Gynecol. 2023 Sep 1;66(3):500-515. doi: 10.1097/GRF.0000000000000790. Epub 2023 Jul 25.
PMID: 37650664DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lois E. Shepherd
- Organization
- Canadian Cancer Trials Group
Study Officials
- STUDY CHAIR
Marie Plante
Canadian Cancer Trials Group
- STUDY CHAIR
Gwenael Ferron
France-GINECO
- STUDY CHAIR
Jae-Weon Kim
Korean Gynecology Oncology Group
- STUDY CHAIR
Christian Marth
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
- STUDY CHAIR
John Tidy
Institute of Cancer Research, United Kingdom
- STUDY CHAIR
Noreen Gleeson
Ireland Co-operative Oncology Research Group
- STUDY CHAIR
Frederic Goffin
Belgian Gynaecological Oncology Group
- STUDY CHAIR
Cor de Kroon
The Dutch Gynecological Oncology Group (DGOG)
- STUDY CHAIR
Xiaohua Wu
Fudan University
- STUDY CHAIR
Sven Mahner
AGO Germany
- STUDY CHAIR
Brynhildur Eyjolfsdottir
Oslo University Hospital
- STUDY CHAIR
Alexey Shevchuk
Hertzen Institute, Moscow
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2012
First Posted
August 7, 2012
Study Start
December 10, 2012
Primary Completion
March 11, 2023
Study Completion
November 4, 2024
Last Updated
December 17, 2024
Results First Posted
November 22, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share