We 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 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.

Condition
Cancer of the Uterine Cervix

Further Study Details: 

Expected Total Enrollment:  280

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

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
• 4. Prior malignancy excluding BCC skin.

Please refer to this study by ClinicalTrials.gov identifier  NCT00193934

Kailash Narayan, FRANZCR      +61 3 96561111    Kailash.Narayan@petermac.org

Australia, Victoria
      Peter MacCallum Cancer Centre, Melbourne,  Victoria,  3002,  Australia

Study chairs or principal investigators

Kailash Narayan, FRANZCR,  Study Chair,  Peter MacCallum Cancer Centre, Australia   

Study ID Numbers:  TROG 04.02
Last Updated:  September 16, 2005
Record first received:  September 12, 2005
ClinicalTrials.gov Identifier:  NCT00193934
Health Authority: Australia: Human Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-20