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ISRCTN
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ISRCTN64141244
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ClinicalTrials.gov identifier
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Public title
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Protocol for a Randomised Phase II Study of the Stanford V regimen compared with ABVD for the treatment of Advanced Hodgkin's Disease
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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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STANFORD V
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Study hypothesis
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To compare the Stanford V regimen with Adriamycin, Bleomycin, Vinblastine, Dacarbazine (ABVD) for the treatment of Advanced Hodgkin's Disease.
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Ethics approval
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This trial is currently awaiting approval for an amendment, and sites will be able to recruit once this has been granted.
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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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Lymphoma (Hodgkin's)
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Participants - inclusion criteria
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1. Histologically confirmed Hodgkin's disease
2. Clinical stage IIB, IIIA, IIIB or IV
3. Aged 18 - 60 years
4. No previous history of malignancy, except for basal cell or squamous cell carcinoma of the skin
5. Normal values for Full Blood Count (FBC), hepatic and renal function, unless directly attributable to involvement by Hodgkin's disease
6. Written informed consent
7. All patients must be assessed by the treating haematologist/medical oncologist and radiation oncologist TOGETHER prior to study entry. This is an absolute requirement for the study eligibility
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Participants - exclusion criteria
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1. Previous therapy for Hodgkin’s disease
2. Clinical evidence of infection with the Human Immunodeficiency Virus (HIV)
3. Pre-existing cardiac or pulmonary disease
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Anticipated start date
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01/01/2001
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Anticipated end date
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30/06/2008
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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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700
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Interventions
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STANFORD V regimen: Chemotherapy with mustine, doxorubicin, vinblastine, prednisolone, vincristine, bleomycin and etoposide
ABVD Regimen: Chemotherapy with doxorubicin, bleomycin, vinblastine and dacarbazine
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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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British National Lymphoma Investigation (BNLI) (UK)
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Trial website
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Publications
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1. 2007 questionnaire-based audit in http://www.ncbi.nlm.nih.gov/pubmed/17959922
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19738111
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Contact name
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Mr
Paul
Mouncey
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Address
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Lymphoma Trials Office
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 7679 8038
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Email
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pm@ctc.ucl.ac.uk
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Sponsor
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British National Lymphoma Investigation (BNLI) (UK)
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Address
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CRC and UCL Cancer Trials Centre
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 7679 8060
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Fax
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+44(0)20 7679 8061
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Email
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bnli@ctc.ucl.ac.uk
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Sponsor website:
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http://www.bnli.ucl.ac.uk
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Date applied
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19/08/2002
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Last edited
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17/11/2009
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Date ISRCTN assigned
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19/08/2002
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