ClinicalTrials.gov

History of Changes for Study: NCT01658930
Radical Versus Simple Hysterectomy and Pelvic Node Dissection in Patients With Early Stage Cervical Cancer
Latest version (submitted July 18, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 August 6, 2012 None (earliest Version on record)
2 August 9, 2012 Eligibility, Arms and Interventions, Study Status and Study Identification
3 November 21, 2012 Study Status
4 April 9, 2013 Recruitment Status, Study Status, Contacts/Locations and Oversight
5 June 7, 2013 Outcome Measures, Study Status and Arms and Interventions
6 December 17, 2013 Study Status
7 February 4, 2014 Contacts/Locations, Study Status and Eligibility
8 August 11, 2014 Study Status
9 October 1, 2014 Study Status and Eligibility
10 October 15, 2014 Contacts/Locations and Study Status
11 May 8, 2015 Arms and Interventions, Study Status, Study Identification, Eligibility, Outcome Measures and Sponsor/Collaborators
12 May 12, 2015 Contacts/Locations and Study Status
13 June 8, 2015 Contacts/Locations and Study Status
14 July 16, 2015 Contacts/Locations and Study Status
15 August 10, 2015 Contacts/Locations and Study Status
16 September 14, 2015 Contacts/Locations and Study Status
17 October 19, 2015 Contacts/Locations and Study Status
18 November 18, 2015 Contacts/Locations and Study Status
19 December 14, 2015 Contacts/Locations and Study Status
20 February 8, 2016 Contacts/Locations and Study Status
21 March 10, 2016 Study Status and Sponsor/Collaborators
22 March 16, 2016 Contacts/Locations and Study Status
23 March 22, 2016 Sponsor/Collaborators and Study Status
24 May 9, 2016 Contacts/Locations and Study Status
25 June 13, 2016 Contacts/Locations and Study Status
26 July 12, 2016 Contacts/Locations and Study Status
27 August 8, 2016 Contacts/Locations and Study Status
28 November 14, 2016 Contacts/Locations and Study Status
29 March 10, 2017 Study Status and Sponsor/Collaborators
30 March 27, 2017 Study Status and Contacts/Locations
31 May 8, 2017 Contacts/Locations and Study Status
32 July 10, 2017 Contacts/Locations and Study Status
33 August 14, 2017 Contacts/Locations and Study Status
34 October 10, 2017 Contacts/Locations and Study Status
35 November 13, 2017 Contacts/Locations and Study Status
36 December 11, 2017 Contacts/Locations and Study Status
37 January 8, 2018 Contacts/Locations and Study Status
38 February 13, 2018 Contacts/Locations and Study Status
39 March 16, 2018 Study Status, Contacts/Locations and Sponsor/Collaborators
40 March 21, 2018 Contacts/Locations and Study Status
41 April 10, 2018 Contacts/Locations and Study Status
42 May 14, 2018 Contacts/Locations and Study Status
43 June 11, 2018 Contacts/Locations and Study Status
44 July 11, 2018 Contacts/Locations and Study Status
45 August 20, 2018 Contacts/Locations and Study Status
46 November 13, 2018 Contacts/Locations and Study Status
47 March 11, 2019 Contacts/Locations and Study Status
48 June 10, 2019 Contacts/Locations, Study Design and Study Status
49 June 19, 2019 Study Status, IPDSharing and Sponsor/Collaborators
50 September 10, 2019 Contacts/Locations and Study Status
51 November 11, 2019 Contacts/Locations and Study Status
52 December 2, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
53 March 24, 2020 Study Status, Oversight, Study Identification and Eligibility
54 February 10, 2021 Study Status
55 January 20, 2022 Study Status
56 July 18, 2022 Outcome Measures, Study Status and Eligibility
Comparison Format:

Scroll up to access the controls

Study NCT01658930
Submitted Date:  August 6, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: CX5
Brief Title: Radical Versus Simple Hysterectomy and Pelvic Node Dissection in Patients With Early Stage Cervical Cancer
Official Title: SHAPE TRIAL: Simple Hysterectomy And Pelvic Node Dissection in Early Cervix Cancer 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
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2012
Overall Status: Not yet recruiting
Study Start: September 2012
Primary Completion: September 2019 [Anticipated]
Study Completion: March 2020 [Anticipated]
First Submitted: August 3, 2012
First Submitted that
Met QC Criteria:
August 6, 2012
First Posted: August 7, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 6, 2012
Last Update Posted: August 7, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: NCIC Clinical Trials Group
Responsible Party: Sponsor
Collaborators: Gynecologic Cancer Intergroup (GCIG)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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.
Open or close this module Conditions
Conditions: Cervical Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 700 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Radical Hysterectomy Procedure: Radical Hysterectomy
Regardless of treatment assignment, surgery will include pelvic lymph node dissection with optional sentinel lymph node (SN) mapping. If SN mapping is to be done, the mode is optional, but the laparoscopic approach is preferred.
Experimental: Simple Hysterectomy Procedure: Simple hysterectomy
Regardless of treatment assignment, surgery will include pelvic lymph node dissection with optional sentinel lymph node (SN) mapping. If SN mapping is to be done, the mode is optional, but the laparoscopic approach is preferred.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Pelvic relapse-free survival
[ Time Frame: 7 years ]

Pelvic relapse-free survival (PRFS), the primary endpoint of this study, is defined as the time from randomization to the time when any documented evidence of recurrence within the pelvic field.
Secondary Outcome Measures:
1. Efficacy comparison between treatment arms
[ Time Frame: 7 years ]

compare the two treatment arms with respect to:

  • Extrapelvic relapse-free survival
  • Relapse-free survival (any site)
  • Overall survival
  • Treatment-related toxicity
  • Patient Reported Outcomes including global quality of life and measures of sexual health
  • Cost-effectiveness and cost-utility
2. Occurrence rates in patient population
[ Time Frame: 7 years ]

observe rates of the following in this patient population:

  • Sentinel node detection
  • Parametrial involvement
  • Involvement of surgical margins
  • Pelvic node involvement
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix diagnosed within 12 weeks prior to randomization. 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:

    • evidence of disease by microscopy;
  • for patients who underwent a LEEP or cone:
  • histologic evidence of depth of stromal invasion between 3.0-5.0 mm based on the local reference pathologist's measurement of the LEEP or cone specimen;
  • histologic evidence of lateral extension that is not greater than 7.0 mm based on the local reference pathologist's measurement of the LEEP or cone specimen; and
  • negative margins
  • 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:

    • a clinically visible lesion or a microscopically diagnosed lesion measuring > 5 mm depth of invasion or > 7 mm in lateral extension;
    • histologic evidence of less than 10mm stromal invasion based on the local reference pathologist's measurement of the LEEP or cone specimen Note: this criterion will not apply to patients who underwent a cervical biopsy only;
    • Radiologic evidence of maximum dimension of ≤ 20 mm as seen by pelvic MRI; and
    • Radiologic evidence of less than 50% stromal invasion based on pelvic MRI. Note: Patients are eligible irrespective of the presence or absence of lymph-vascular space involvement (LVSI).
  • The histologic grade of cervical cancer must be 1, 2, 3 or not assessable [FIGO Annual Report, 2009].
  • 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. Staging criteria described in 5.1.2 must be satisfied based on these examinations.
  • 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 required (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 not required 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, French or Spanish must be willing to complete the Quality of Life Questionnaire and the Sexual Health Questionnaire. The baseline assessments must be completed within 6 weeks prior to randomization. Inability (illiteracy in English, French or Spanish, 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 enrollment 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 8 weeks of randomization.
  • Patients must be ≥ 18 years old.

Exclusion Criteria:

  • 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.
Open or close this module Contacts/Locations
Central Contact Person: Ralph Meyer
Telephone: 6135336430
Email: rmeyer@ctg.queensu.ca
Study Officials: Marie Plante
Study Chair
CHUQ - Hotel-Dieu de Quebec
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services