Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer
NCT ID: NCT01658930
Last Updated: 2024-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
700 participants
INTERVENTIONAL
2012-12-10
2024-11-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radical Hysterectomy
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.
Simple Hysterectomy
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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:
* histologic evidence of depth of stromal invasion between 5.1-10 mm and/or lateral extension between 7.1-20.0 mm based on the local reference pathologist's measurement of the LEEP or cone specimen
* for patients who underwent a cervical biopsy only:
* radiologic evidence of less than 50% stromal invasion based on pelvic MRI
* lateral extension ≤ 20 mm based on clinical exam or radiologic imaging.
In addition to above criteria on maximal stromal invasion of ≤ 10 mm, the lesion must be no larger than 20 mm in any dimension by any assessment method (MRI, clinical or histological exam). To ensure patients meet this criterion, investigators may need to sum the lesion measurements from biopsy and other methods that evaluate it in the same plane.
Patients are eligible irrespective of the presence or absence of lymph-vascular space involvement (LVSI).
* Physical examination, recto-vaginal examination and visualization of the cervix by speculum or colposcopic examination have been done after the initial diagnostic procedure (LEEP, cone or biopsy) and prior to randomization.
* Chest x-ray or CT scan of chest AND pelvic MRI\* done after initial diagnostic procedure (LEEP, cone or biopsy) and prior to randomization.
The CT should be a 16 slice (or higher) helical scanner. Oral and intravenous contrasts are preferred (unless there is a contraindication to the use of contrast) with scan obtained in the portal phase at a slice thickness of 5mm or lower Pelvic MRI should be performed on a 1.5 or 3 Tesla magnet with pelvic phased-array coils. The MR pulse sequences will consist of T1 gradient echo in the axial plane at 5 mm slice thickness and fast spin echo in the axial, sagittal, and coronal planes at 4 mm slice thickness. The short axis (perpendicular to the tumour's long axis) with a 3 mm slice thickness is required in the best plane to show the maximum thickness of stromal invasion. Use of an anti-peristaltic agent is mandatory while intravenous use of gadolinium or diffusion-weighted imaging (DWI) is optional.
\* Note: pelvic MRI is optional if the patient has stage IA2 disease and underwent a LEEP or cone.
* After consideration of a patient's medical history, physical examination and laboratory testing, patients must be suitable candidates for surgery as defined by the attending physician / investigator.
* Patients must have no desire to preserve fertility.
* Patients fluent in English or French must be willing to complete the Quality of Life Questionnaire. The baseline assessments must be completed within 6 weeks prior to randomization. Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible. As additional GCIG groups join the study, more translations of some of the questionnaires may be added.
Patients fluent in English or French who reside in Canada and the United Kingdom must agree to participate in the economic evaluation component of this trial and complete the Health Economics Questionnaire. Similarly, patients fluent in English or French accrued from other GCIG groups who are participating in the economic evaluation must be willing to complete the Health Economics Questionnaires.
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate.
* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
* Surgery is to be done within 20 weeks of initial diagnosis (NO EXCEPTIONS). The 20-week period includes time required for diagnosis, referral, diagnostic staging, randomization and scheduling of the surgical procedure.
* Patients must be ≥ 18 years old.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Gynecologic Cancer Intergroup (GCIG)
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Korean Gynecologic Oncology Group
OTHER
Dutch Gynaecological Oncology Group
OTHER
Cancer Trials Ireland
NETWORK
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
OTHER
Belgian Gynaecological Oncology Group
OTHER
ARCAGY/ GINECO GROUP
OTHER
Institute of Cancer Research, United Kingdom
OTHER
Shanghai Cancer Centre
OTHER
P. Herzen Moscow Oncology Research Institute
OTHER_GOV
Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom Germany
OTHER
Institut Universitaire du Cancer de Toulouse
OTHER
Canadian Cancer Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Marie Plante
Role: STUDY_CHAIR
Canadian Cancer Trials Group
Gwenael Ferron
Role: STUDY_CHAIR
France-GINECO
Jae-Weon Kim
Role: STUDY_CHAIR
Korean Gynecology Oncology Group
Christian Marth
Role: STUDY_CHAIR
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
John Tidy
Role: STUDY_CHAIR
Institute of Cancer Research, United Kingdom
Noreen Gleeson
Role: STUDY_CHAIR
Ireland Co-operative Oncology Research Group
Frederic Goffin
Role: STUDY_CHAIR
Belgian Gynaecological Oncology Group
Cor de Kroon
Role: STUDY_CHAIR
The Dutch Gynecological Oncology Group (DGOG)
Xiaohua Wu
Role: STUDY_CHAIR
Fudan University
Sven Mahner
Role: STUDY_CHAIR
AGO Germany
Brynhildur Eyjolfsdottir
Role: STUDY_CHAIR
Oslo University Hospital
Alexey Shevchuk
Role: STUDY_CHAIR
Hertzen Institute, Moscow
Locations
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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
Liège, , Belgium
CHU Sart Tilman Liege
Liège, , 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
Québec, 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
Chambéry, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Centre Jean Perrin - 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
Nîmes, , 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
Düsseldorf, , Germany
Kaiserswerther Diakonie - Florence-Nightingale-Krankenhaus
Düsseldorf, , Germany
Kliniken Essen Mitte
Essen, , Germany
Universitaetsfrauenklinik Freiburg
Freiburg im Breisgau, , Germany
Universitaetsfrauenklinik Greifswald
Greifswald, , Germany
Universitaetsklinikum Hamburg - Eppendorf
Hamburg, , Germany
Agaplesion Diakonieklinikum Hamburg
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaetsklinikum des Saarlandes
Homburg-Saar, , Germany
Universitaetsfrauenklinik Jena
Jena, , Germany
Universitaetsfrauenklinik Luebeck
Lübeck, , Germany
Universitaetsfrauenklinik Mainz
Mainz, , Germany
Klinikum der Universitaet Muenchen - LMU Campus Grosshadern
München, , Germany
Universitaetsfrauenklinik Tuebingen
Tübingen, , 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, , Russia
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
Countries
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References
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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.
Kwon 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.
Ferguson 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.
Boisen 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CX5
Identifier Type: -
Identifier Source: org_study_id