Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer

Cancer of the Uterine Cervix Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193934
• Other study ID #: TROG 04.02
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: July 10, 2017
• Start date: January 2006
• Est. completion date: May 15, 2014

Study information

• Verified date: July 2017
• Source: Trans-Tasman Radiation Oncology Group (TROG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: May 15, 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of the Uterine Cervix
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal Brisbane Hospital	Herston	Queensland
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Calvary Mater Newcastle	Newcastle	New South Wales
Australia	Royal North Shore Hospital	Sydney	New South Wales
Australia	North Queensland Oncology Service	Townsville	Queensland
Australia	Premion - Tugun	Tugun	Queensland
Australia	Westmead Hospital	Wentworthville	New South Wales
India	Tata Memorial Hospital	Mumbai
India	Meenakshi Mission Hospital	Tamil Nadu
New Zealand	Auckland Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Dunedin Hospital	Dunedin
Singapore	National University Hospital	Singapore
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Trans-Tasman Radiation Oncology Group (TROG)	Peter MacCallum Cancer Centre, Australia

Countries where clinical trial is conducted

United States,  Australia,  India,  New Zealand,  Singapore, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		End of study

External Links

•   Click here for more information about this study on the TROG official website