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

18 Years
Not Enrolling
Cancer of the Uterine Cervix

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Trial Information

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

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

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

It is intended to collect follow up information on all patients until one year after the
final patient is registered on study.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Kailash Narayan, FRANZCR

Investigator Role:

Study Chair

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia


Australia: Human Research Ethics Committee

Study ID:

TROG 04.02



Start Date:

January 2006

Completion Date:

December 2012

Related Keywords:

  • Cancer of the Uterine Cervix
  • 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
  • Uterine Cervical Neoplasms



Washington University School of Medicine Saint Louis, Missouri  63110