Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000145404
Ethics application status
Approved
Date submitted
21/02/2007
Date registered
26/02/2007
Date last updated
19/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 04.02 - Prospective Study to Determine the Relationships Between Survival and International Federation of Gynecology and Obstetrics (FIGO) Stage, Tumour Volume and Corpus Invasion in relation to prognostic information in patients with Cervical Cancer
Secondary ID [1] 345 0
ClinicalTrials.gov: NCT00193934
Universal Trial Number (UTN)
Trial acronym
TROG 04.02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer of the uterine cervix 1639 0
Condition category
Condition code
Cancer 1748 1748 0 0
Womb (Uterine or endometrial cancer)
Cancer 1749 1749 0 0
Cervical (Cervix)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Newly diagnosed cervical cancer patients will have key prognostic variables (FIGO stage, tumour diameter, corpus invasion etc) 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. The duration will be 5 years.
Intervention code [1] 1481 0
None
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2436 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] 2436 0
Patients will be followed up at yearly intervals until death.
Primary outcome [2] 2437 0
Assess the prognostic significance, with respect to overall survival, of the factors, tumour volume. Overall survival is defined as the date of registration to date of death from any cause.
Timepoint [2] 2437 0
Patients will be followed up at yearly intervals until death.
Primary outcome [3] 2438 0
Assess the prognostic significance, with respect to overall survival, of the factors, corpus invasion. Overall survival is defined as the date of registration to date of death from any cause.
Timepoint [3] 2438 0
Patients will be followed up at yearly intervals until death.
Secondary outcome [1] 4205 0
Assess the degree of correlation between maximum clinical diameter of the tumour and primary tumour volume, determined after baseline assessment (time of registration)
Timepoint [1] 4205 0
The tumour is only measured at this time point. After treatment, only the site and date of first relapse is followed up.
Secondary outcome [2] 4206 0
Assess what relationships exist between FIGO stage, tumour volume and corpus invasion, determined after baseline assessment (time of registration)
Timepoint [2] 4206 0
The tumour is only measured at this time point. After treatment, only the site and date of first relapse is followed up.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Lymphoma, small cell carcinoma and melanoma histology.- Previous hysterectomy- Pregnancy- Prior malignancy excluding basal cell carcinoma (BCC) of the skin.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/01/2002
Actual
6/01/2006
Date of last participant enrolment
Anticipated
Actual
9/06/2009
Date of last data collection
Anticipated
Actual
15/05/2015
Sample size
Target
280
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment outside Australia
Country [1] 439 0
New Zealand
State/province [1] 439 0
Country [2] 440 0
Singapore
State/province [2] 440 0

Funding & Sponsors
Funding source category [1] 1896 0
Other Collaborative groups
Name [1] 1896 0
Royal Australian and New Zealand College of Radiologists
Country [1] 1896 0
Australia
Funding source category [2] 1897 0
Hospital
Name [2] 1897 0
Auckland Hospital
Country [2] 1897 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
TROG Cancer Research
Address
c/- Calvary Mater Newcastle
Edith Street
Waratah
NSW
2298
Country
Australia
Secondary sponsor category [1] 1715 0
None
Name [1] 1715 0
Address [1] 1715 0
Country [1] 1715 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3522 0
Auckland Hospital
Ethics committee address [1] 3522 0
Multi-Region Ethics Committee
Ministry of Health
180 Molesworth St
PO Box 5013
Wellington
Ethics committee country [1] 3522 0
New Zealand
Date submitted for ethics approval [1] 3522 0
Approval date [1] 3522 0
Ethics approval number [1] 3522 0
Ethics committee name [2] 3523 0
Christchurch Hospital
Ethics committee address [2] 3523 0
Christachurch, NZ
Ethics committee country [2] 3523 0
New Zealand
Date submitted for ethics approval [2] 3523 0
Approval date [2] 3523 0
Ethics approval number [2] 3523 0
Ethics committee name [3] 3524 0
Dunedin Hospital
Ethics committee address [3] 3524 0
Dunedin, Otago, NZ
Ethics committee country [3] 3524 0
New Zealand
Date submitted for ethics approval [3] 3524 0
Approval date [3] 3524 0
Ethics approval number [3] 3524 0
Ethics committee name [4] 3525 0
National University Hospital
Ethics committee address [4] 3525 0
Ethics committee country [4] 3525 0
Singapore
Date submitted for ethics approval [4] 3525 0
Approval date [4] 3525 0
Ethics approval number [4] 3525 0
Ethics committee name [5] 3526 0
Calvary Mater Newcastle
Ethics committee address [5] 3526 0
Waratah, NSW
Ethics committee country [5] 3526 0
Australia
Date submitted for ethics approval [5] 3526 0
Approval date [5] 3526 0
Ethics approval number [5] 3526 0
Ethics committee name [6] 3527 0
Peter MacCallum Cancer Centre
Ethics committee address [6] 3527 0
Melbourne, VIC
Ethics committee country [6] 3527 0
Australia
Date submitted for ethics approval [6] 3527 0
Approval date [6] 3527 0
28/07/2005
Ethics approval number [6] 3527 0
Ethics committee name [7] 3528 0
Royal Brisbane and Women’s Hospital
Ethics committee address [7] 3528 0
Herston, QLD
Ethics committee country [7] 3528 0
Australia
Date submitted for ethics approval [7] 3528 0
Approval date [7] 3528 0
Ethics approval number [7] 3528 0
Ethics committee name [8] 3529 0
Royal North Shore Hospital
Ethics committee address [8] 3529 0
St Leonards, NSW
Ethics committee country [8] 3529 0
Australia
Date submitted for ethics approval [8] 3529 0
Approval date [8] 3529 0
Ethics approval number [8] 3529 0
Ethics committee name [9] 3530 0
Townsville Hospital
Ethics committee address [9] 3530 0
Townsville, QLD
Ethics committee country [9] 3530 0
Australia
Date submitted for ethics approval [9] 3530 0
Approval date [9] 3530 0
Ethics approval number [9] 3530 0
Ethics committee name [10] 3531 0
Westmead Hospital
Ethics committee address [10] 3531 0
Wentworthville, NSW
Ethics committee country [10] 3531 0
Australia
Date submitted for ethics approval [10] 3531 0
Approval date [10] 3531 0
Ethics approval number [10] 3531 0
Ethics committee name [11] 7008 0
Liverpool Hospital
Ethics committee address [11] 7008 0
Liverpool, NSW
Ethics committee country [11] 7008 0
Australia
Date submitted for ethics approval [11] 7008 0
Approval date [11] 7008 0
Ethics approval number [11] 7008 0
2006/108

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
www.trog.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27415 0
Dr Farshad Foroudi
Address 27415 0
Peter MacCallum Cancer Centre
St Andrew's Place
Melbourne
VIC
3002
Country 27415 0
Australia
Phone 27415 0
+61 2 3 96561111
Fax 27415 0
Email 27415 0
[email protected]
Contact person for public queries
Name 10670 0
Rebecca Montgomery
Address 10670 0
TROG Cancer Research
PO Box 88
Waratah NSW 2298
Country 10670 0
Australia
Phone 10670 0
+61 2 4014 3911
Fax 10670 0
+61 2 4014 3902
Email 10670 0
[email protected]
Contact person for scientific queries
Name 1598 0
Rebecca Montgomery
Address 1598 0
TROG Cancer Research
PO Box 88
Waratah NSW 2298
Country 1598 0
Australia
Phone 1598 0
+61 2 4014 3911
Fax 1598 0
Email 1598 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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