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
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.