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ISRCTN
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ISRCTN57679341
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ClinicalTrials.gov identifier
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Public title
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LCH-II Langerhans cell histiocytosis: treatment protocol of the second international 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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LCH 9605
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Study hypothesis
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To compare intensification of treatment with an improved outcome.
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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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Austria, United Kingdom
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Disease/condition/study domain
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Miscellaneous
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Participants - inclusion criteria
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1. Definitive diagnosis of Langerhans cell histiocytosis
2. Aged under 18 years with involvement of haematopetic system, liver, lungs or spleen or aged under 2 years
3. No prior treatment for Langerhans cell histiocytosis
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Participants - exclusion criteria
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Does not comply with above criteria
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Anticipated start date
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01/01/2002
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Anticipated end date
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31/12/2007
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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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193
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Interventions
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Risk group patients are randomised to either:
1. Arm A: Initial treatment with oral prednisone and vinblastine. Continuation treatment with oral 6-mercaptopurine plus pulses of oral prednisone and vinblastine.
2. Arm B: Initial treatment with oral prednisone and vinblastine. Continuation treatment with oral 6-mercaptopurine plus pulses of oral prednisone and vinblastine followed by etoposide.
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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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Children's Cancer Research Institute (Austria)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18089850
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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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01/07/2001
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Last edited
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04/08/2008
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Date ISRCTN assigned
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01/07/2001
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