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Sponsors and Collaborators: |
Trans-Tasman Radiation Oncology Group (TROG) Peter MacCallum Cancer Centre, Australia |
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Information provided by: | Trans-Tasman Radiation Oncology Group (TROG) |
ClinicalTrials.gov Identifier: | NCT00193934 |
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.
Condition |
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Cancer of the Uterine Cervix |
Study Type: | Observational |
Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
Official Title: | Prospective Study to Determine the Relationships Between Survival and FIGO Stage, Tumour Volume and Corpus Invasion in Cervical Cancer |
Estimated Enrollment: | 280 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | September 2010 |
Groups/Cohorts |
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1: Case
Cervical Cancer Patients
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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:
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 older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kailash Narayan, FRANZCR | +61 3 96561111 | Kailash.Narayan@petermac.org |
United States, Missouri | |
Washington University School of Medicine | Not yet recruiting |
St Louis, Missouri, United States, 63110 | |
Australia, New South Wales | |
Liverpool Hospital | Recruiting |
Liverpool, New South Wales, Australia, 1871 | |
Contact: Shalini Vinod +61 2 9828 5276 shalini.vinod@swsahs.nsw.gov.au | |
Newcastle Mater Misericordiae Hospital | Recruiting |
Newcastle, New South Wales, Australia, 2298 | |
Contact: Peter O'Brien +61 2 4921 1175 Peter.Obrien@mater.health.nsw.gov.au | |
Royal North Shore Hospital | Recruiting |
Sydney, New South Wales, Australia, 2069 | |
Contact: Graeme Morgan +61 2 9926 5010 Gmorgan@nsccahs.health.nsw.gov.au | |
Westmead Hospital | Recruiting |
Wentworthville, New South Wales, Australia, 2145 | |
Contact: Viet Do +61 2 9845 6499 vietdo@radonc.wsahs.nsw.gov.au | |
Australia, Queensland | |
East Coast Cancer Centre | Not yet recruiting |
Tugun, Queensland, Australia, 4224 | |
Contact: Helen Peres | |
Royal Brisbane Hospital | Recruiting |
Herston, Queensland, Australia, 4029 | |
Contact: Robyn Cheuk +61 7 3636 7687 Robyn_Cheuk@health.qld.gov.au | |
North Queensland Oncology Service | Recruiting |
Townsville, Queensland, Australia, 4810 | |
Contact: Joshua Dass +61 7 4796 1622 joshua_dass@health.qld.gov.au | |
Australia, South Australia | |
Royal Adelaide Hospital | Not yet recruiting |
Adelaide, South Australia, Australia, 5000 | |
Contact: Eric Yeoh +61 8 8222 4000 eyeoh@mail.rah.sa.gov.au | |
Australia, Victoria | |
Peter MacCallum Cancer Centre | Recruiting |
Melbourne, Victoria, Australia, 3002 | |
Contact: Kailash Narayan, FRANZCR +61 3 9656 1111 Kailash.Narayan@petermac.org | |
India | |
Tata Memorial Hospital | Not yet recruiting |
Mumbai, India | |
Meenakshi Mission Hospital | Not yet recruiting |
Tamil Nadu, India | |
New Zealand | |
Christchurch Hospital | Recruiting |
Christchurch, New Zealand, 4710 | |
Auckland Hospital | Recruiting |
Auckland, New Zealand, 1001 | |
Contact: Maria Pearse +64 9 307 4949 mariap@adhb.govt.nz | |
Dunedin Hospital | Recruiting |
Dunedin, New Zealand | |
Contact: John North +64 3 474 7947 johnn@healthotago.co.nz | |
Singapore | |
National University Hospital | Recruiting |
Singapore, Singapore |
Study Chair: | Kailash Narayan, FRANZCR | Peter MacCallum Cancer Centre, Australia |
Study ID Numbers: | TROG 04.02 |
Study First Received: | September 12, 2005 |
Last Updated: | July 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00193934 |
Health Authority: | Australia: Human Research Ethics Committee |
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 |
Genital Diseases, Female Uterine Cervical Neoplasms Uterine Cervical Diseases Genital Neoplasms, Female |
Neoplasm Metastasis Uterine Diseases Uterine Neoplasms Urogenital Neoplasms |
Neoplasms Neoplasms by Site |