Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer

This study has suspended participant recruitment.
(Trial Management related issues)
Sponsor:
Collaborator:
Peter MacCallum Cancer Centre, Australia
Information provided by:
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00193934
First received: September 12, 2005
Last updated: September 30, 2009
Last verified: September 2009
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study to Determine the Relationships Between Survival and FIGO Stage, Tumour Volume and Corpus Invasion in Cervical Cancer

Resource links provided by NLM:


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

Estimated Enrollment: 280
Study Start Date: January 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
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
Sampling Method:   Non-Probability Sample
Study Population

Newly diagnosed cervical cancer patients, Female

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

Locations
United States, Missouri
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Australia, New South Wales
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2069
Westmead Hospital
Wentworthville, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane Hospital
Herston, Queensland, Australia, 4029
North Queensland Oncology Service
Townsville, Queensland, Australia, 4810
Premion - Tugun
Tugun, Queensland, Australia, 4224
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3002
India
Tata Memorial Hospital
Mumbai, India
Meenakshi Mission Hospital
Tamil Nadu, India
New Zealand
Auckland Hospital
Auckland, New Zealand, 1001
Christchurch Hospital
Christchurch, New Zealand, 4710
Dunedin Hospital
Dunedin, New Zealand
Singapore
National University Hospital
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:
Responsible Party: Associate Professor Kailash Narayan, Trans Tasman Radiation Oncology Group
ClinicalTrials.gov Identifier: NCT00193934     History of Changes
Other Study ID Numbers: TROG 04.02
Study First Received: September 12, 2005
Last Updated: September 30, 2009
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

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

ClinicalTrials.gov processed this record on April 17, 2014