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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.
Full 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.
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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
Primary purpose
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700 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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