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ISRCTN
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ISRCTN68133429
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DOI
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10.1186/ISRCTN68133429
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A trial comparing conventional fractionation with 'CHART' in the treatment of head and neck cancer
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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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CH02
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Study hypothesis
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To compare the effectiveness of radical fractionated radiotherapy given daily over 6 weeks with CHART over 12 days, with respect to local tumour control, survival and morbidity
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Lay summary
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Not provided at time of registration
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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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Cancer
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Participants - inclusion criteria
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1. Histologically proven squamous cell carcinoma of all grades at one of the following sites: Nasal sinuses, Nasopharynx, Oral cavity, Oropharynx, Hypopharynx, Carcinoma of the larynx
2. A radical course of external beam radiotherapy is the appropriate sole treatment
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Participants - exclusion criteria
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There should be no evidence of distant metastases beyond the regional nodes in the neck
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Anticipated start date
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01/01/1990
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Anticipated end date
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01/03/1995
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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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500
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Interventions
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Conventional radiotherapy arm - 2 Gy, once daily five days a week over six weeks (large volume - 44 Gy in 22 fractions followed by small volume - 16 Gy in eight fractions)
CHART arm - 1.5 Gy, three time daily over 12 treatment days (large volume - 37.5 Gy in 25 fractions followed by small volume - 16.5 Gy in 11 fractions)
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Primary outcome measure(s)
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1. Local tumour control
2. Survival
3. Morbidity
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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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Contact name
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Dr
James
Lyddiard
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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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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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05/11/2012
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Date ISRCTN assigned
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28/02/2001
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