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ISRCTN
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ISRCTN11978947
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ClinicalTrials.gov identifier
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Public title
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Interferon alpha in combination with thalidomide in the treatment of metastatic renal cell carcinoma - a randomised phase II study
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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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CO0.024
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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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Metastatic renal cell carcinoma
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Participants - inclusion criteria
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1. Measurable progressive disease (greater than 1 cm non-irradiated marker lesions)
2. Calculated creatinine clearance greater than 60 ml/min or ethylene diamine tetra-acetic acid (EDTA) clearance greater than 40 ml/min
3. Normal bilirubin
4. Liver enzymes less than 5 x upper limit of normal range
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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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01/02/2001
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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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Two arms:
1. Interferon-alpha three times per week. The first three doses will be 4.5 miu, 4.5 miu, 9 mui, then 9 mui six times each fortnight, for 12 weeks initially, then for a further 12 weeks if stable disease or better. Then 12-weekly cycles until progression.
2. Interferon-alpha and thalidomide. Interferon as above. Thalidomide 200 mg per day orally to be taken at night at least 2 h after the evening meal.
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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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UK Co-ordinating Committee for Cancer Research (UKCCCR)
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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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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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unknown@sponsor.com
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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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