Radical Versus Simple Hysterectomy and Pelvic Node Dissection in Patients W... | Recruiting
Radical Versus Simple Hysterectomy ... | Recruiting
Radical Versus Simple Hysterectomy and Pelvic Node Dissection in Patients With Low-risk Early Stage Cervical Cancer (SHAPE)

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Medical Conditions
  • Cervical Cancer
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01658930
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
  • 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.
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Procedure : Radical Hysterectomy + pelvic lymph node dissection, Procedure : Simple hysterectomy + pelvic lymph node dissection

Study Arm Groups : Radical Hysterectomy, Simple Hysterectomy

Intervention Type
See Interventions above
Primary Outcome Measures
    Pelvic relapse-free survival; 7 years
Secondary Outcome Measures
    Efficacy comparison between treatment arms; 7 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Female
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
700
Participant Inclusion Criteria
    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:

    - 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;

    - 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:

    - 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Kent and Canterbury Hospital
Canterbury
England
CT1 3NG
Truro
TR1 3LJ
Southend NHS Trust Hospital
Southend-on-Sea
England
SS0 0RY
Middlesbrough
TS4 3BW
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
Portsmouth
Hampshire
PO6 3LY
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
Glossop Road
S10 2TJ
Trial Contact(s)
Primary Trial Contact
Lois Shepherd
6135336430
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Austria, Belgium, Canada, China, France, Germany, Ireland, Netherlands, Russian Federation, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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)
EudraCT Number
Not available for this trial
Funder(s)
  • GCIG: Gynecologic Cancer InterGroup
  • Canadian Institutes of Health Research (CIHR)
  • Korean Gynecologic Oncology Group
  • Dutch Gynecologic Oncology Group
  • Cancer Trials Ireland
  • Arbeitsgemeinschaft Gynaekologische Onkologie Austria
  • Belgium Gynecologic Oncology Group
  • Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens
  • Institute of Cancer Research, United Kingdom
  • European Society of Gynecological Oncology
  • Shanghai Cancer Centre Deptartment of Gynecologic Oncology Fudan University
  • Hertzen Moscow Scientific Research Institute of Oncology
  • Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom Germany
Other Study ID Numbers
CX5
Sponsor(s)
Canadian Cancer Trials Group
Key Dates

Recruitment Start Date

Aug 2012

Recruitment End Date

Sep 2019

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

03 Aug 2012

Date updated in source

14 Aug 2017