Cancer of the Uterine CervixNCT00193934
Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer
An observational study of Cancer of the Uterine Cervix, run by Trans Tasman Radiation Oncology Group at 16 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer of the Uterine Cervix
- How many people
- 109 participants
- Where
- 16 sitesin 5 countries
- Study dates
- Jan 2006to 15 May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed cervical cancer patients, Female
Who may be able to join
- 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
Show all 9Show fewer
- Treatment not yet started.
- Written informed consent.
- Available for follow-up.
Who cannot join
- Lymphoma, small cell carcinoma and melanoma histology.
- Previous hysterectomy
- Pregnancy
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
Australia9 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Royal Brisbane Hospital
Herston, Queensland, 4029
Liverpool Hospital
Liverpool, New South Wales, 1871
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3002
Calvary Mater Newcastle
Newcastle, New South Wales, 2298
Royal North Shore Hospital
Sydney, New South Wales, 2069
North Queensland Oncology Service
Townsville, Queensland, 4810
Premion - Tugun
Tugun, Queensland, 4224
Westmead Hospital
Wentworthville, New South Wales, 2145
New Zealand3 sites
Auckland Hospital
Auckland, 1001
Christchurch Hospital
Christchurch, 4710
Dunedin Hospital
Dunedin
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Prospective Study to Determine the Relationships Between Survival and FIGO Stage, Tumour Volume and Corpus Invasion in Cervical Cancer
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.
Read the 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.
- Conditions
- Cancer of the Uterine Cervix
- Keywords
- 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
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Cervical Cancer Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJan 2006
- Primary completionMay 2014
- Study completion15 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer of the Uterine CervixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Peter MacCallum Cancer Centre, Australia
- Responsible party
- Principal investigator, TROG Administrator, Trans Tasman Radiation Oncology Group
- Investigators
- Gerard Adams, Study chair, Oceania Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193934
- Sponsor's protocol ID
- TROG 04.02
- Status last verified
- Jul 2017
- First submitted
- 12 Sep 2005
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1097/01.coc.0000091358.78047.b5.
PubMed 14528092Narayan 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. doi: 10.1046/j.1525-1438.2003.13026.x.
PubMed 14675351Narayan 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. doi: 10.1111/j.1525-1438.2005.00128.x.
PubMed 16014109
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Determine the Relationships Between Survival and FIGO Stage, Tumour Volume and Corpus Invasion in Cervical Cancer
- ClinicalTrials.gov ID
- NCT00193934
- Acronym / sponsor ID
- TROG 04.02
- Conditions
- Cancer of the Uterine Cervix
- Keywords
- 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 type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Trans Tasman Radiation Oncology GroupUniversity, hospital or other
- Collaborators
- Peter MacCallum Cancer Centre, Australia
- Study start
- Jan 2006
- Primary completion
- May 2014 (actual)
- Study completion
- 15 May 2014 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Cervical Cancer Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed cervical cancer patients, Female
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- Lymphoma, small cell carcinoma and melanoma histology.
- Previous hysterectomy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: End of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Background: PubMed 14528092Narayan 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. doi: 10.1097/01.coc.0000091358.78047.b5.
- Background: PubMed 14675351Narayan 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. doi: 10.1046/j.1525-1438.2003.13026.x.
- Background: PubMed 16014109Narayan 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. doi: 10.1111/j.1525-1438.2005.00128.x.
- Click here for more information about this study on the TROG official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Adams study chair
Oceania Oncology
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of the Uterine Cervix, run by Trans Tasman Radiation Oncology Group at 16 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Australia, New Zealand, India, United States, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00193934, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.