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ISRCTN
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ISRCTN79554459
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DOI
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10.1186/ISRCTN79554459
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A study of potentially curative local therapy alone, or preceded by chemotherapy, in the treatment of Stage Ib-IVa cervical carcinoma
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Scientific title
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Acronym
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N/A
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Serial number at source
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CeCa
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Study hypothesis
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This study aims to address the question of whether neo-adjuvant chemotherapy provides a survival advantage over local treatment alone in patients with cervical carcinoma.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cervical cancer
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Participants - inclusion criteria
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1. Histologically proven invasive cancer of the cervix Stage Ib through to IVa
2. Patients must be fit enough to receive adjuvant chemotherapy, and the chosen definitive treatment
3. World Health Organisation (WHO) performance status zero to one or creatinine clearance of at least 60 ml/min
4. The informed consent of the patient
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Participants - exclusion criteria
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1. Previous chemotherapy
2. Renal, hepatic or bone marrow dysfunction which in the opinion of the investigator is sufficient to prejudice therapy (including local treatment and chemotherapy
3. Previous malignancy other than basal cell carcinoma
4. Medical or psychological conditions precluding treatment
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Anticipated start date
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01/01/1991
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Anticipated end date
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03/11/1995
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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313 participants intended, only 48 randomised.
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Interventions
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Chemotherapy patients randomised to chemotherapy, will receive this treatment prior to local therapy. Chemotherapy will consist of: cisplatin (50 mg/m^2), methotrexate (100 mg/m^2) and folinic acid (15 mg orally every six hours, to commence 30 hours after the start of intravenous cisplatin and methotrexate, for eight doses). Cisplatin and methotrexate will be given intravenously for three cycles, once every two to three weeks depending upon tolerance. Adequate hydration should be given before and after administration of cisplatin. No immediate chemotherapy (local therapy). Because of the diversity of approach with regard to surgery and especially radiotherapy, no specific schedule will be laid down.
However all patients entering the study should receive radical local treatment which is regarded as potentially curative within that situation. Ideally, each institution should use a standard treatment policy throughout the study. Local therapy should be started as soon as possible after diagnosis or within three weeks of completing chemotherapy in those patients randomised to chemotherapy.
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Primary outcome measure(s)
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Survival and time to recurrence
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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Trial not published on its own. The results were published in the meta-analysis entitled Neoadjuvant chemotherapy for locally advanced cervical cancer: a systematic review and meta-analysis of individual patient data from 21 randomised trials. Neoadjuvant Chemotherapy for Cervical Cancer Meta-analysis Collaboration (European Journal of Cancer 39 [2003] 2470-2486) - see http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14602133
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Contact name
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Prof
Max
Parmar
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Email
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Max.parmar@ctu.mrc.ac.uk
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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28/02/2001
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Last edited
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31/07/2009
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Date ISRCTN assigned
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28/02/2001
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