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Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer
This study is currently recruiting participants.
Verified by Trans-Tasman Radiation Oncology Group (TROG), July 2007
First Received: September 12, 2005   Last Updated: July 31, 2007   History of Changes
Sponsors and Collaborators: Trans-Tasman Radiation Oncology Group (TROG)
Peter MacCallum Cancer Centre, Australia
Information provided by: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00193934
  Purpose

The researchers propose that it may be corpus invasion, rather than tumour volume per se, which is one of the important determinants of ultimate outcome in cervix cancer. The aim of the proposed prospective, multicentre study, is to confirm the results of our retrospective studies, specifically that corpus invasion or tumour volume or both contribute important prognostic information over and above that provided by the currently used International Federation of Gynecology and Obstetrics (FIGO) staging system. A successful outcome would have important implications for the staging, and management as well as the biologic understanding of the behaviour of cervical cancer.


Condition
Cancer of the Uterine Cervix

MedlinePlus related topics: Cancer Cervical Cancer MRI Scans
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study
Official Title: Prospective Study to Determine the Relationships Between Survival and FIGO Stage, Tumour Volume and Corpus Invasion in Cervical Cancer

Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Estimated Enrollment: 280
Study Start Date: September 2005
Estimated Study Completion Date: September 2010
Groups/Cohorts
1: Case
Cervical Cancer Patients

Detailed Description:

This will be a prospective, multicentre, prognostic factor, follow-up study. The study is designed to be as simple as possible: newly diagnosed cervical cancer patients will have key prognostic variables collected at baseline. The treatment received will be documented at the end of treatment and patients will then be followed for first relapse and survival.

Registration of a patient on this study can be undertaken after EUA, biopsy confirmed diagnosis, anatomic staging diagram and MRI have been done and before any treatment has commenced.

Treatment must be curative in intent (termed radical therapy) but otherwise can be at the discretion of the investigator. Radical hysterectomy alone, hysterectomy followed by adjuvant radiotherapy, radical chemo-radiotherapy or radical radiotherapy will be allowed. Details of the planned and given treatment regimen will be recorded.

All patients will have the following trial data documented at the time of registration:

  • Age
  • ECOG performance status
  • smoking status
  • date of histological diagnosis
  • histologic type and features
  • presenting haemoglobin
  • standard FIGO staging
  • maximum clinical tumour diameter measured at EUA
  • detailed staging diagram drawn at EUA
  • nodal status (by surgical pathology or CT or MRI or both and PET if available)
  • date of MRI
  • MRI tumour diameters
  • presence or absence of corpus invasion on MRI
  • planned treatment details

All patients will be assessed pre-treatment, immediately following treatment and will be followed up for local control and survival at yearly intervals from the date of registration.

It is intended to collect follow up information on all patients until one year after the final patient is registered on study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Newly diagnosed, biopsy proven carcinoma of the uterine cervix.
  2. Squamous cell, adenocarcinoma, adenosquamous or large cell carcinoma histology.
  3. FIGO Stage Ib -IVa.
  4. Maximum clinical tumour diameter recorded.
  5. MRI done within 30 days prior to registration.
  6. Intention to treat radically
  7. Treatment not yet started.
  8. Written informed consent.
  9. Available for follow-up.

Exclusion Criteria:

  1. Lymphoma, small cell carcinoma and melanoma histology.
  2. Previous hysterectomy
  3. Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193934

Contacts
Contact: Kailash Narayan, FRANZCR +61 3 96561111 Kailash.Narayan@petermac.org

Locations
United States, Missouri
Washington University School of Medicine Not yet recruiting
St Louis, Missouri, United States, 63110
Australia, New South Wales
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 1871
Contact: Shalini Vinod     +61 2 9828 5276     shalini.vinod@swsahs.nsw.gov.au    
Newcastle Mater Misericordiae Hospital Recruiting
Newcastle, New South Wales, Australia, 2298
Contact: Peter O'Brien     +61 2 4921 1175     Peter.Obrien@mater.health.nsw.gov.au    
Royal North Shore Hospital Recruiting
Sydney, New South Wales, Australia, 2069
Contact: Graeme Morgan     +61 2 9926 5010     Gmorgan@nsccahs.health.nsw.gov.au    
Westmead Hospital Recruiting
Wentworthville, New South Wales, Australia, 2145
Contact: Viet Do     +61 2 9845 6499     vietdo@radonc.wsahs.nsw.gov.au    
Australia, Queensland
East Coast Cancer Centre Not yet recruiting
Tugun, Queensland, Australia, 4224
Contact: Helen Peres            
Royal Brisbane Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Robyn Cheuk     +61 7 3636 7687     Robyn_Cheuk@health.qld.gov.au    
North Queensland Oncology Service Recruiting
Townsville, Queensland, Australia, 4810
Contact: Joshua Dass     +61 7 4796 1622     joshua_dass@health.qld.gov.au    
Australia, South Australia
Royal Adelaide Hospital Not yet recruiting
Adelaide, South Australia, Australia, 5000
Contact: Eric Yeoh     +61 8 8222 4000     eyeoh@mail.rah.sa.gov.au    
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3002
Contact: Kailash Narayan, FRANZCR     +61 3 9656 1111     Kailash.Narayan@petermac.org    
India
Tata Memorial Hospital Not yet recruiting
Mumbai, India
Meenakshi Mission Hospital Not yet recruiting
Tamil Nadu, India
New Zealand
Christchurch Hospital Recruiting
Christchurch, New Zealand, 4710
Auckland Hospital Recruiting
Auckland, New Zealand, 1001
Contact: Maria Pearse     +64 9 307 4949     mariap@adhb.govt.nz    
Dunedin Hospital Recruiting
Dunedin, New Zealand
Contact: John North     +64 3 474 7947     johnn@healthotago.co.nz    
Singapore
National University Hospital Recruiting
Singapore, Singapore
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Peter MacCallum Cancer Centre, Australia
Investigators
Study Chair: Kailash Narayan, FRANZCR Peter MacCallum Cancer Centre, Australia
  More Information

Additional Information:
Publications:
Study ID Numbers: TROG 04.02
Study First Received: September 12, 2005
Last Updated: July 31, 2007
ClinicalTrials.gov Identifier: NCT00193934     History of Changes
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Women's Health
Multidisciplinary, multicentre prospective study
Cancer:mechanisms of growth, invasion, metastases
Figo Stages cervical cancer
Advances in diagnosis using radiological methods
Quantitative Magnetic Resonance Imaging
Patient Management Strategies
Selecting patients for therapy

Study placed in the following topic categories:
Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Genital Neoplasms, Female
Neoplasm Metastasis
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

Additional relevant MeSH terms:
Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009