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Cervical CancerSHAPENCT01658930

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

A study testing Radical Hysterectomy + pelvic lymph node dissection and Simple hysterectomy + pelvic lymph node dissection in people with Cervical Cancer, run by Canadian Cancer Trials Group at 87 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Radical Hysterectomy + pelvic lymph node dissection and Simple hysterectomy + pelvic lymph node dissection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
87 sitesin 11 countries
Study dates
10 Dec 2012to 4 Nov 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 33Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

87 sites in 11 countries.

87 sites in 11 countries

France28 sites

  • CHU Amiens

    Amiens, 80054

  • Institut Bergonie Bordeaux

    Bordeaux, 33076

  • CHRU de Brest

    Brest, 29609

  • CHU de Chambery

    Chambéry, 73011

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003

  • Centre Jean Perrin - Clermont-Ferrand

    Clermont-Ferrand, 63011

  • Centre Georges Francois Leclerc - Dijon

    Dijon, 21079

  • CHU de Dijon

    Dijon, 21079

  • Centre Oscar Lambret - Lille

    Lille, 59000

  • CHRU de Lille

    Lille, 59037

  • CHU Limoges

    Limoges, 87042

  • Hospices Civils de Lyon

    Lyon, 69229

  • Centre Leon Berard - Lyon

    Lyon, 69373

  • Institut Paoli Calmettes - Marseille

    Marseille, 13273

  • Institut Regional du Cancer de Montpellier

    Montpellier, 34298

  • Institut Arnault Tzank - Mougins

    Mougins, 06254

  • CHU de Nice

    Nice, 06003

  • CHU de Nimes

    Nîmes, 30029

  • Hopital Europeen Georges Pompidou - Paris

    Paris, 75015

  • CHU de Reims

    Reims, 51092

  • CHU de Rennes

    Rennes, 35033

  • Clinique Mutualiste de la Sagesse - Rennes

    Rennes, 35043

  • Clinique Mathilde - Rouen

    Rouen, 76175

  • ICO - Rene Gauducheau

    Saint-Herblain, 44805

  • CHU de Strasbourg

    Strasbourg, 67091

  • CHU de Bordeaux

    Talence, 33404

  • Institut Claudius Regaud - Toulouse

    Toulouse, 31059

  • CHRU de Tours

    Tours, 37044

Other trials in France

Germany21 sites

  • Hochtaunus-Kliniken gGmbH

    Bad Homburg, 61352

  • DRK Kliniken Berlin Koepenick

    Berlin, 12559

  • DRK Klinikum Berlin Westend

    Berlin, 14050

  • Martin-Luther-Krankenhaus Berlin

    Berlin, 14193

  • GYNAEKOLOGICUM Bremen

    Bremen, 28211

  • Universitaetsfrauenklinik Duesseldorf

    Düsseldorf, 40225

  • Kaiserswerther Diakonie - Florence-Nightingale-Krankenhaus

    Düsseldorf, 40489

  • Kliniken Essen Mitte

    Essen, 45136

  • Universitaetsfrauenklinik Freiburg

    Freiburg im Breisgau, 79106

  • Universitaetsfrauenklinik Greifswald

    Greifswald, 17475

  • Universitaetsklinikum Hamburg - Eppendorf

    Hamburg, 20246

  • Agaplesion Diakonieklinikum Hamburg

    Hamburg, 20259

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitaetsklinikum des Saarlandes

    Homburg-Saar, 66421

  • Universitaetsfrauenklinik Jena

    Jena, 07747

  • Universitaetsfrauenklinik Luebeck

    Lübeck, 23538

  • Universitaetsfrauenklinik Mainz

    Mainz, 55131

  • Klinikum der Universitaet Muenchen - LMU Campus Grosshadern

    München, 81377

  • Universitaetsfrauenklinik Tuebingen

    Tübingen, 72076

  • Universitaetsfrauenklinik Ulm

    Ulm, 89075

  • Marien-Hospital Witten

    Witten, 58452

Other trials in Germany

Canada16 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Greenfield Park, Quebec, J4V 2H1

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • London Regional Cancer Program

    London, Ontario, N6A 5W9

  • Trillium Health Partners - Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

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

    Montreal, Quebec, H1T 2M4

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • Study site

    Québec, Quebec, G1R 2J6

  • CIUSSS de l'Estrie - Centre hospitalier

    Sherbrooke, Quebec, J1H 5N4

  • University Health Network

    Toronto, Ontario, M5G 2M9

  • Clinical Research Unit at Vancouver Coastal

    Vancouver, British Columbia, V5Z 1M9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Austria7 sites

  • Barmherzige Brueder Graz

    Graz, 8020

  • Medical University of Graz

    Graz, 8036

  • Medical University of Innsbruck

    Innsbruck, 6020

  • LKH Leoben

    Leoben, 8700

  • Landes- Frauen- und Kinderklinik Linz

    Linz, 4020

  • LKH Salzburg

    Salzburg, 5020

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

United Kingdom6 sites

  • East Kent Hospitals University NHS Foundation Trust

    Canterbury, Ethelbert Road, CT1 3NG

  • South Tees Hospitals NHS Foundation Trust

    Middlesbrough, Marton Road, TS4 3BW

  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, Glossop Road, S10 2TJ

  • Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ

  • Southend University Hospital

    Westcliff-on-Sea, Essex, SS0 0RY

Other trials in United Kingdom

Belgium3 sites

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000

  • CHR de la Citadelle liege

    Liège, 4000

  • CHU Sart Tilman Liege

    Liège, 4000

Other trials in Belgium

Netherlands2 sites

  • LUMC

    Leiden, 2300 RC

  • Erasmus MC

    Rotterdam, 3000CA

Other trials in Netherlands

China1 site

  • Shanghai Cancer Center

    Shanghai, 200032

Other trials in China

Ireland1 site

  • St James Hospital

    Dublin, Leinster, Dublin 8

Other trials in Ireland

Norway1 site

  • Oslo University Hospital

    Oslo, Postboks 4953 Nydalen, 0424

Other trials in Norway

Russia1 site

  • Hertzen Moscow Scientific Research

    Moscow

Other trials in Russia

About this study

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)

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.

Read the 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.

Conditions
Cervical Cancer
Being tested
Radical Hysterectomy + pelvic lymph node dissection, Simple hysterectomy + pelvic lymph node dissection
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radical Hysterectomy + pelvic lymph node dissectionProcedure or surgery

    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 dissectionProcedure or surgery

    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.

Study groups in NCT01658930
Study groupRoleWhat they receive
Radical HysterectomyActive comparatorNot described
Receives: Procedure: Radical Hysterectomy + pelvic lymph node dissection
Simple HysterectomyExperimentalNot described
Receives: Procedure: Simple hysterectomy + pelvic lymph node dissection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years

Secondary outcomes (4)

  1. Pelvic Relapse-free Survival

    It 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 year pelvic relapse-free survival was estimated by Kaplan-Meier method.

    Measured: 3 years

  2. Extra-pelvic Relapse-free Survival

    It was defined as the time from randomization to the documented reappearance of disease provided that this recurrence is outside of pelvic. Patients who relapsed in pelvic field were censored at the time of first documented pelvic relapse. Patients who died before any relapse or alive without recurrence were censored at the date of death or last known alive date. 3 year extra-pelvic relapse-free survival was estimated by Kaplan-Meier method.

    Measured: 3 years

  3. Relapse-free Survival

    It was defined as the time from randomization to the first time when either a pelvic or extra-pelvic recurrence was documented. Patients who died before any recurrence or alive without recurrence were censored at the date of death or last known alive date. 3 year relapse-free survival was estimated by Kaplan-Meier method.

    Measured: 3 years

  4. Overall Survival

    It was defined as the time from randomization until death from any cause. The living patients were censored at the date of last known alive. 3 year overall survival was estimated by Kaplan-Meier method.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2012 (estimated)
  2. Study start10 Dec 2012
  3. Primary completion11 Mar 2023
  4. Study completion4 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01658930
Sponsor's protocol ID
CX5
Acronym
SHAPE
Status last verified
Nov 2024
First submitted
3 Aug 2012
Last updated
17 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38416430

  • 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.

    PubMed 39453395

  • 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.

    PubMed 39353164

  • 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.

    PubMed 37650664

Questions about this trial

What is this clinical trial studying?

A study testing Radical Hysterectomy + pelvic lymph node dissection and Simple hysterectomy + pelvic lymph node dissection in people with Cervical Cancer, run by Canadian Cancer Trials Group at 87 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in France, Germany, Canada, Austria, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pelvic Recurrence Rate at 3 Years (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01658930, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.

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