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ISRCTN
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ISRCTN76747656
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ClinicalTrials.gov identifier
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Public title
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A phase II randomised study of cisplatinum and nifedipine in end stage 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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LIVERPL-HN1
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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 cancer
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Participants - inclusion criteria
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1. Patients with either advanced squamous cell carcinoma of the head and neck, not previously treated, or recurrent squamous cell carcinoma of the head and neck after previous radiotherapy or surgery
2. Measurable histologically confirmed, squamous cell carcinoma of the head and neck. The primary sites will be:
2.1. Mouth
2.2. Nasopharynx
2.3. Oropharynx
2.4. Hypopharynx
2.5. Larynx
2.6. Nose and sinuses
2.7. Middle ear
3. No prior chemotherapy
4. Not suitable for surgery or radiotherapy with a curative purpose
5. Karnofsky performance greater than 50
6. Minimum of three weeks since prior radiotherapy and or surgery and patients must have fully recovered from such prior treatments
7. Adequate bone marrow and renal function
8. No active infection
9. No concomitant or prior malignancy except adequately treated basal cell carcinoma of the skin and in situ carcinoma of the uterine cervix
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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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01/01/2003
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Anticipated end date
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01/01/2004
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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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Patients are randomised to one of two treatment regimens:
1. Group A: Cisplatinum repeated every 21 days for a maximum of six cycles
2. Group B: Cisplatinum plus nifedipine repeated every 21 days for a maximum of six cycles
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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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Not provided at time of registration
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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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North West Cancer Research Fund (UK)
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Address
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22 Oxford Street
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City/town
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Liverpool
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Zip/Postcode
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L7 7BL
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Country
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United Kingdom
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Tel
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+44 (0)151709 2919
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Fax
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+44 (0)151 708 7997
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Email
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GenSec@cancerresearchnorthwest.co.uk
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Date applied
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19/08/2002
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Last edited
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19/05/2008
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Date ISRCTN assigned
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19/08/2002
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