Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gynecologic Cancer Intergroup (GCIG) | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Korean Gynecologic Oncology Group | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radical Hysterectomy | Active Comparator |
| |
| Simple Hysterectomy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical Hysterectomy + pelvic lymph node dissection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
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:
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:
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).
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.
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barmherzige Brueder Graz | Graz | 8020 | Austria | |||
| Medical University of Graz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38416430 | Result | 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. | |
| 39453395 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 16, 2022 | May 31, 2024 |
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Simple hysterectomy + pelvic lymph node dissection | Procedure | 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. |
|
| 3 years |
| 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. | 3 years |
| 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. | 3 years |
| 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. | 3 years |
| Study Chair |
| Brynhildur Eyjolfsdottir | Oslo University Hospital | Study Chair |
| Alexey Shevchuk | Hertzen Institute, Moscow | Study Chair |
| 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 |
| 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 |
| 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 |
| Derived |
| 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. |
| 39353164 | Derived | 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. |
| 37650664 | Derived | 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. |
| FG001 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
All participants randomized to this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All patients randomized. | Posted | Number | 90% Confidence Interval | percentage of participants | 3 years |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All patients randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All patients randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All patients randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All patients randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years |
|
Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 7 | 344 | 0 | 344 | 208 | 344 |
| EG001 | 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. | 7 | 338 | 0 | 338 | 181 | 338 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspareunia | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lois E. Shepherd | Canadian Cancer Trials Group | 6135336430 | LShepherd@ctg.queensu.ca |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 6, 2022 | May 31, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Austria |
|
| Netherlands |
|
| Belgium |
|
| Norway |
|
| China |
|
| Ireland |
|
| United Kingdom |
|
| France |
|
| Germany |
|
| Russia |
|
| South Korea |
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|