Radical Versus Simple Hysterectomy and Pelvic Node Dissection in Patients With Low-risk Early Stage Cervical Cancer (SHAPE)
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Radical Hysterectomy + pelvic lymph node dissection Type: Procedure
Name: Simple hysterectomy + pelvic lymph node dissection Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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.
Locations
Barmherzige Brueder Graz
Graz, Austria
Status: Recruiting
Contact: Peter Lang
Medical University of Graz
Graz, Austria
Status: Recruiting
Contact: Arnim Bader
Medical University of Innsbruck
Innsbruck, Austria
Status: Recruiting
Contact: Astrid Berger
LKH Leoben
Leoben, Austria
Status: Recruiting
Contact: George Ralph
Landes- Frauen- und Kinderklinik Linz
Linz, Austria
Status: Recruiting
Contact: Lukas Angleitner-boubenizek
LKH Salzburg
Salzburg, Austria
Status: Recruiting
Contact: Gerhard Bogner
Medical University of Vienna
Vienna, Austria
Status: Recruiting
Contact: Alexander Reinthaller
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Status: Recruiting
Contact: Ignace Vergote
CHU Sart Tilman Liege
Liege, Belgium
Status: Not yet recruiting
Contact: Frederic Kridelka
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Status: Recruiting
Contact: Prafull Ghatage - 403 521-3721
Cross Cancer Institute
Edmonton, Alberta, Canada
Status: Recruiting
Contact: Tiffany Wells - 780 432-8902
Clinical Research Unit at Vancouver Coastal
Vancouver, British Columbia, Canada
Status: Recruiting
Contact: Janice Smith Kwon - 604 875-4203
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Status: Recruiting
Contact: Alon Altman - 204 787-3684
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada
Status: Withdrawn
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Status: Recruiting
Contact: James Bentley - 902 473-2366
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Status: Withdrawn
London Regional Cancer Program
London, Ontario, Canada
Status: Recruiting
Contact: Michel Prefontaine - 519 685-8088
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Status: Recruiting
Contact: Michael Fung Kee Fung - 613 737-8560
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
Status: Recruiting
Contact: Sarah Ferguson - 416 946-4501
Hopital Charles LeMoyne
Greenfield Park, Quebec, Canada
Status: Recruiting
Contact: Omar Moreira Bacha - 514 831-2572
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada
Status: Recruiting
Contact: Vanessa Samouelian - 514 890-8444
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Status: Recruiting
Contact: Suzanne Fortin - 514 252-3400
McGill University - Dept. Oncology
Montreal, Quebec, Canada
Status: Recruiting
Contact: Susie K.S. Lau - 514 340-8222
CHUQ-Pavillon Hotel-Dieu de Quebec
Quebec City, Quebec, Canada
Status: Recruiting
Contact: Marie Plante - 418 691-5392
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Status: Recruiting
Contact: Paul Bessette - 819 346-1110
Shanghai Cancer Center
Shanghai, China
Status: Recruiting
Contact: Xiaohua Wu - 216 417-5590
CHU Amiens
Amiens, France
Status: Recruiting
Contact: Sophie Sanguin
CHU de Chambery
Chambery, France
Status: Recruiting
Contact: Caroline Deyrolle
Centre Oscar Lambret - Lille
Lille, France
Status: Not yet recruiting
Contact: Eric Leblanc
Institut Arnault Tzank - Mougins
Mougins, France
Status: Recruiting
Contact: Dominique L Lanvin
CHU de Bordeaux
Talence, France
Status: Recruiting
Contact: Jean-luc Brun
Institut Claudius Regaud - Toulouse
Toulouse, France
Status: Recruiting
Contact: Gwenael Ferron
Centre Alexis Vautrin - Nancy
Vandoeuvre Les Nancy, France
Status: Recruiting
Contact: Frederic Marchal
St James Hospital
Dublin, Leinster, Ireland
Status: Recruiting
Contact: Noreen Gleeson
Leiden
Leiden, Netherlands
Status: Recruiting
Contact: Cor de Kroon - 61 540-8037
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Status: Not yet recruiting
Contact: Khadra Galaal
Southend University Hospital
Westcliff-on-Sea, Essex, United Kingdom
Status: Not yet recruiting
Contact: Khalil Razvi
East Kent Hospitals University NHS Foundation Trust
Canterbury, Ethelbert Road, United Kingdom
Status: Not yet recruiting
Contact: Andrew Nordin
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, Glossop Road, United Kingdom
Status: Not yet recruiting
Contact: John Tidy
South Tees Hospitals NHS Foundation Trust
Middlesbrough, Marton Road, United Kingdom
Status: Not yet recruiting
Contact: Jeremy Twigg
Start Date
September 2012
Completion Date
September 2020
Sponsors
NCIC Clinical Trials Group
Source
NCIC Clinical Trials Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page