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ISRCTN
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ISRCTN93127929
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ClinicalTrials.gov identifier
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Public title
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UKHAN1 - A Trial of Chemotherapy With Radiotherapy in the Treatment of Advanced Squamous Carcinoma of the Head and Neck
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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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UKCCCRUKHAN1
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Study hypothesis
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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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Head and Neck
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Participants - inclusion criteria
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1. Histological confirmation of squamous cell carcinoma
2. All stages, except T1N0
3. No occult primaries
4. No evidence of distant metastases
5. Fit and willing to receive any of the randomised treatment options
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Participants - exclusion criteria
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Not provided at time of registration
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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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31/12/1991
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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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Not provided at time of registration
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Interventions
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1. Group A: Radiotherapy alone.
2. Group B: Radiotherapy plus simultaneous chemotherapy (two courses during radiotherapy).
3.Group C: Radiotherapy plus subsequent chemotherapy (two courses to start 14 days and 28 days following radiotherapy).
4. Group D: Radiotherapy plus simultaneous and subsequent chemotherapy. (A total of four courses of chemotherapy, two simultaneous with radiotherapy treatment and two 14 days and 28 days following the completion of radiotherapy.)
Radiotherapy is given according to standard local practices. Suggested radiotherapy regimens include 60 Gy in 6 weeks or 45-55 Gy in 3-4 weeks. Recommended chemotherapy regimens are single agent methotrexate or combination chemotherapy with vincristine, bleomycin, methotrexate and 5-fluorouracil (VBMF). Patients in whom the primary tumour has been surgically excised are randomised to group A or group B only.
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Primary outcome measure(s)
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Not provided at time of registration
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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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Cancer Research UK
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
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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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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19/08/2002
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Last edited
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14/05/2008
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Date ISRCTN assigned
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19/08/2002
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