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Spots Global Cancer Trial Database for Induction Chemotherapy Plus Chemoradiation as First Line Treatment for Locally Advanced Cervical Cancer

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Trial Identification

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

Conditions

Cervical Cancer

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Mary Dr McCormack, MBBS, FRCR

Affiliation: University College London Hospitals

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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