Magnetic Resonance Imaging (MRI) Staging of Cervix 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.

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Key information

Conditions

Cancer of the Uterine Cervix Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Liverpool Hospital, Liverpool, New South Wales, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

Lymphoma, small cell carcinoma and melanoma histology.
Previous hysterectomy
Pregnancy

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Trans Tasman Radiation Oncology Group

Other

Collaborators

Peter MacCallum Cancer Centre, Australia

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2014
Study completion: 2014
First posted: Sep 19, 2005
Registry last updated: Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed