Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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Age
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ECOG performance status
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smoking status
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date of histological diagnosis
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histologic type and features
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presenting haemoglobin
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standard FIGO staging
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maximum clinical tumour diameter measured at EUA
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detailed staging diagram drawn at EUA
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nodal status (by surgical pathology or CT or MRI or both and PET if available)
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date of MRI
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MRI tumour diameters
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presence or absence of corpus invasion on MRI
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Cervical Cancer Patients |
Outcome Measures
Primary Outcome Measures
- Assess the prognostic significance, with respect to overall survival, of the factors, FIGO stage. Overall survival is defined as the date of registration to date of death from any cause. [End of study]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Newly diagnosed, biopsy proven carcinoma of the uterine cervix.
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Squamous cell, adenocarcinoma, adenosquamous or large cell carcinoma histology.
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FIGO Stage Ib -IVa.
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Maximum clinical tumour diameter recorded.
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MRI done within 30 days prior to registration.
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Intention to treat radically
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Treatment not yet started.
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Written informed consent.
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Available for follow-up.
Exclusion Criteria:
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Lymphoma, small cell carcinoma and melanoma histology.
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Previous hysterectomy
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 2 | Liverpool Hospital | Liverpool | New South Wales | Australia | 1871 |
| 3 | Calvary Mater Newcastle | Newcastle | New South Wales | Australia | 2298 |
| 4 | Royal North Shore Hospital | Sydney | New South Wales | Australia | 2069 |
| 5 | Westmead Hospital | Wentworthville | New South Wales | Australia | 2145 |
| 6 | Royal Brisbane Hospital | Herston | Queensland | Australia | 4029 |
| 7 | North Queensland Oncology Service | Townsville | Queensland | Australia | 4810 |
| 8 | Premion - Tugun | Tugun | Queensland | Australia | 4224 |
| 9 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
| 10 | Peter MacCallum Cancer Centre | Melbourne | Victoria | Australia | 3002 |
| 11 | Tata Memorial Hospital | Mumbai | India | ||
| 12 | Meenakshi Mission Hospital | Tamil Nadu | India | ||
| 13 | Auckland Hospital | Auckland | New Zealand | 1001 | |
| 14 | Christchurch Hospital | Christchurch | New Zealand | 4710 | |
| 15 | Dunedin Hospital | Dunedin | New Zealand | ||
| 16 | National University Hospital | Singapore | Singapore |
Sponsors and Collaborators
- Trans Tasman Radiation Oncology Group
- Peter MacCallum Cancer Centre, Australia
Investigators
- Study Chair: Gerard Adams, Oceania Oncology
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Narayan K, McKenzie A, Fisher R, Susil B, Jobling T, Bernshaw D. Estimation of tumor volume in cervical cancer by magnetic resonance imaging. Am J Clin Oncol. 2003 Oct;26(5):e163-8.
- Narayan K, McKenzie AF, Hicks RJ, Fisher R, Bernshaw D, Bau S. Relation between FIGO stage, primary tumor volume, and presence of lymph node metastases in cervical cancer patients referred for radiotherapy. Int J Gynecol Cancer. 2003 Sep-Oct;13(5):657-63.
- Narayan K. Arguments for a magnetic resonance imaging-assisted FIGO staging system for cervical cancer. Int J Gynecol Cancer. 2005 Jul-Aug;15(4):573-82. Review.
- TROG 04.02