Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer
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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 |
| 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 |
Newly diagnosed cervical cancer patients, Female
Inclusion Criteria:
- Newly diagnosed, biopsy proven carcinoma of the uterine cervix.
- Squamous cell, adenocarcinoma, adenosquamous or large cell carcinoma histology.
- FIGO Stage Ib -IVa.
- Maximum clinical tumour diameter recorded.
- MRI done within 30 days prior to registration.
- Intention to treat radically
- Treatment not yet started.
- Written informed consent.
- Available for follow-up.
Exclusion Criteria:
- Lymphoma, small cell carcinoma and melanoma histology.
- Previous hysterectomy
- Pregnancy
Contacts and 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 | |
| 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 June 13, 2013