Clinical trial NCT00193934: Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer
Official title: Prospective Study to Determine the Relationships Between Survival and FIGO Stage, Tumour Volume and Corpus Invasion in Cervical Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Trans Tasman Radiation Oncology Group
Sponsor class: OTHER
Collaborators: name: Peter MacCallum Cancer Centre, Australia
First posted: 2005-09-19
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed cervical cancer patients, Female

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.

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 criteria: 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

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Sydney
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Wentworthville
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane Hospital
state: Queensland
city: Townsville
country: Australia
facility: North Queensland Oncology Service
state: Queensland
city: Tugun
country: Australia
facility: Premion - Tugun
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Mumbai
country: India
facility: Tata Memorial Hospital
city: Tamil Nadu
country: India
facility: Meenakshi Mission Hospital
city: Auckland
country: New Zealand
facility: Auckland Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: Oceania Oncology
name: Gerard Adams
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.