Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer

NCT ID: NCT00193934

Last Updated: 2017-07-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 109 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2014-05-15

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.

Conditions

Cancer of the Uterine Cervix

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Cervical Cancer Patients

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peter MacCallum Cancer Centre, Australia

OTHER

Sponsor Role: collaborator

Trans Tasman Radiation Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

TROG Administrator

Rebecca Montgomery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerard Adams

Role: STUDY_CHAIR

Oceania Oncology

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Liverpool Hospital

Liverpool, New South Wales, Australia

Calvary Mater Newcastle

Newcastle, New South Wales, Australia

Royal North Shore Hospital

Sydney, New South Wales, Australia

Westmead Hospital

Wentworthville, New South Wales, Australia

Royal Brisbane Hospital

Herston, Queensland, Australia

North Queensland Oncology Service

Townsville, Queensland, Australia

Premion - Tugun

Tugun, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Tata Memorial Hospital

Mumbai, , India

Meenakshi Mission Hospital

Tamil Nadu, , India

Auckland Hospital

Auckland, , New Zealand

Christchurch Hospital

Christchurch, , New Zealand

Dunedin Hospital

Dunedin, , New Zealand

National University Hospital

Singapore, , Singapore

Countries

United States; Australia; India; New Zealand; Singapore

References

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.

Reference Type: BACKGROUND

PMID: 14528092 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14675351 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16014109 (View on PubMed)

Related Links

http://www.trog.com.au

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

Other Identifiers

TROG 04.02

Identifier Type: -

Identifier Source: org_study_id