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Brief Title: Induction Chemotherapy Plus Chemoradiation as First Line Treatment for Locally Advanced Cervical Cancer
Official Title: A Phase III Multicentre Trial of Weekly Induction Chemotherapy Followed by Standard Chemoradiation Versus Standard Chemoradiation Alone in Patients With Locally Advanced Cervical Cancer
Study ID: NCT01566240
Brief Summary: Chemoradiation has been the standard treatment for advanced cervical cancer for a decade, but one third of women still die from a failure to control systemic disease. In a recent multicentre phase II trial of 46 women the investigators found that, 68% of women had tumours that responded to weekly induction chemotherapy prior to chemoradiation. The induction chemotherapy had acceptable toxicity and did not compromise the standard chemoradiation treatment. In addition, the overall survival and progression free survival at 3 years was 66% (95% CI 4779). These results, together with acceptable toxicity, provide justification for evaluating induction chemotherapy prior to chemoradiation in a randomised phase III trial. The investigators aim to investigate in a randomised trial whether additional induction chemotherapy given on a weekly schedule immediately before standard chemoradiation leads to an improvement in overall survival. The investigators plan to recruit 770 women with locally advanced cervical cancer who are eligible for standard chemoradiation, they will be randomised to weekly carboplatin and paclitaxel chemotherapy for 6 weeks followed by chemoradiation or to chemoradiation alone. The trial will recruit for 4 years with 5 years of follow up period.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Instituto do Câncer do Estado de São Paulo, São Paulo, , Brazil
Chittaranjan National Cancer Institute (CNCI), Kolkata, , India
Saroj Gupta Cancer Centre and Research Institute, Kolkata, , India
Istituto Europeo di Oncologia, Milan, Lombardy, Italy
Instituto Nacional de Cancerologia (INCAN), Mexico City, , Mexico
North Devon District Hospital, Barnstaple, Devon, United Kingdom
University College London Hospital, London, Greater London, United Kingdom
Weston Park Hospital, Sheffield, South Yorkshire, United Kingdom
Belfast City Hospital, Belfast, , United Kingdom
Pilgrim Hospital, Boston, , United Kingdom
Royal Sussex County Hospital, Brighton, , United Kingdom
Velindre Cancer Centre, Cardiff, , United Kingdom
Cheltenham General Hospital, Cheltenham, , United Kingdom
Royal Derby Hospital, Derby, , United Kingdom
Royal Devon and Exeter NHS Foundation Trust, Exeter, , United Kingdom
Beatson WOSCC, Glasgow, , United Kingdom
Gloucester Royal Hospital, Gloucester, , United Kingdom
Grantham and District Hospital, Grantham, , United Kingdom
Castle Hill Hospital, Hull, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
Lincoln County Hospital, Lincoln, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust, London, , United Kingdom
Imperial College Healthcare NHS Trust, London, , United Kingdom
St Bart's Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
James Cook University Hospital, Middlesbrough, , United Kingdom
Northampton General Hospital, Northampton, , United Kingdom
Norfolk and Norwich University Hospital, Norwich, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Royal Stoke University Hospital, Stoke-On-Trent, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
The Clatterbridge Cancer Centre, Wirral, , United Kingdom
New Cross Hospital, Wolverhampton, , United Kingdom
Name: Mary Dr McCormack, MBBS, FRCR
Affiliation: University College London Hospitals
Role: PRINCIPAL_INVESTIGATOR