Clinical trial · Observational

Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer

Prospective Study to Determine the Relationships Between Survival and FIGO Stage, Tumour Volume and Corpus Invasion in Cervical Cancer

NCT00193934CI-TRIAL-00028583completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cancer of the Uterine Cervix	—	UNRESOLVED	—

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (1)

label
1
description
Cervical Cancer Patients

Primary outcomes (1)

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.
timeFrame
End of study

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (3)

BACKGROUNDNarayan 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. PMID 14528092
BACKGROUNDNarayan 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. PMID 14675351
BACKGROUNDNarayan 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. PMID 16014109

Registry

Dates and enrollment

Start: Jan 1, 2006
Primary completion: May 1, 2014
Completion: May 15, 2014
First posted: Sep 19, 2005
Last update posted: Jul 12, 2017
Enrollment: 109 (actual)
Lead sponsor: Trans Tasman Radiation Oncology Group OTHER
Collaborators: Peter MacCallum Cancer Centre, Australia
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

Data updated 22 days agoSource updated Jul 12, 2017source: clinicaltrials

Locations

Locations by country (16)

Country	Sites	Recruiting
Australia	9	0
New Zealand	3	0