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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00193934




Registration number
NCT00193934
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
12/07/2017

Titles & IDs
Public title
Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer
Scientific title
Prospective Study to Determine the Relationships Between Survival and FIGO Stage, Tumour Volume and Corpus Invasion in Cervical Cancer
Secondary ID [1] 0 0
TROG 04.02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer of the Uterine Cervix 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1 - Cervical Cancer Patients
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
End of study

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Lymphoma, small cell carcinoma and melanoma histology.
2. Previous hysterectomy
3. Pregnancy

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2014
Sample size
Target
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [4] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [5] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [6] 0 0
North Queensland Oncology Service - Townsville
Recruitment hospital [7] 0 0
Premion - Tugun - Tugun
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
1871 - Liverpool
Recruitment postcode(s) [2] 0 0
2298 - Newcastle
Recruitment postcode(s) [3] 0 0
2069 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Wentworthville
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
4810 - Townsville
Recruitment postcode(s) [7] 0 0
4224 - Tugun
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Missouri
Country [2] 0 0
India
State/province [2] 0 0
Mumbai
Country [3] 0 0
India
State/province [3] 0 0
Tamil Nadu
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland
Country [5] 0 0
New Zealand
State/province [5] 0 0
Christchurch
Country [6] 0 0
New Zealand
State/province [6] 0 0
Dunedin
Country [7] 0 0
Singapore
State/province [7] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Peter MacCallum Cancer Centre, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00193934
Trial related presentations / 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.
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. doi: 10.1046/j.1525-1438.2003.13026.x.
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. doi: 10.1111/j.1525-1438.2005.00128.x.
Public notes

Contacts
Principal investigator
Name 0 0
Gerard Adams
Address 0 0
Oceania Oncology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00193934